Post-Concussion Syndrome, Traumatic Brain Injury With Brief Loss of Consciousness
Conditions
Keywords
HBO2, HBOT, mTBI, Brain injury, PCS, PTSD, hyperbaric oxygen
Brief summary
Purpose of this study is to investigate the mechanisms of action of hyperbaric oxygen therapy for persistent post-concussive symptoms after mild tramatic brain injury
Detailed description
Active duty military personnel and Veterans received for 60-minute daily chamber sessions in which they received HBO2, 1.5 atmospheres absolute (ATA), or sham intervention (1.2 ATA, room air) for post concussion syndrome (PCS). The study is to provide a rationale for the selection of outcome assessments to serve as primary and secondary endpoints for a pivotal randomized clinical trial of hyperbaric oxygen for the treatment of PCS. The participants will undergo a comprehensive battery of symptom and quality of life assessments. The distribution of response, change in response over time, homogeneity of variance across subgroups, and relationships between outcome measures will be compared by treatment assignment with a cohort from a study of similar design among a normal study population.
Interventions
DRUGHyperbaric oxygen (HBO2) at 1.5 atms
The Hyperbaric oxygen (HBO2) at 1.5 atms (active) group (hyperbaric oxygen-chamber compressed to 1.5 atm abs and breathing 100% oxygen). Each participant should complete 40 sessions over the course of 12 weeks, one session per day, five per week.
DRUGSham control 1.2 atms
The chamber will be compressed with air to 1.2 atm abs to simulate the active group. Participants will don a hood and breathe 21% oxygen (room air). Each participant will complete 40 sessions, one session per day, five sessions per week, within 12 weeks following randomization. Breathing air at a pressure of 1.2 atm abs is equivalent to inhaling 25% oxygen at sea level pressure (1.0 atm abs).
Sponsors
U.S. Army Medical Research and Development Command
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* On active duty (TRICARE beneficiary) at the time of consent and through the 6-month visit or a Veteran, as well as Active Duty military who become Veterans after enrollment. * Men and women 18-65 years of age at the time of study enrollment. * Able to equalize middle ear pressure in a test of chamber pressure and tolerate the chamber environment. * Able to speak and read English, as primary language. * Agrees to and appears able to participate in all outcome assessments. * Agrees to provide blood samples for clinical lab tests. * Demonstrates the ability to offer informed consent and signs the study informed consent document. * Participants stationed or living outside the Colorado Springs/Denver, Colorado area must be willing and able to travel. A reliable companion may accompany the participant if travel supervision is required. * Active duty participants must obtain a letter of support from a supervisor or commanding officer prior to the outcome assessments (and travel, if necessary) to the OAC. Participants must have a history of at least one (minimum requirement) mild traumatic brain injury (mTBI) with persistent symptoms that meets all the following criteria: * Brain injury that occurred more than 3 months prior to baseline screening at the local site, with the most recent injury occurring no more than 5 years prior to randomization. * Most recent traumatic brain injury (TBI) occurred on active duty. * TBI was caused by non-penetrating trauma or blast exposure. * TBI resulted in at least one of the following at the time of injury: a period of loss of or a decreased level of consciousness (up to 30 minutes); a loss of memory for events immediately before or after the injury (up to 24 hours); or alteration in mental state at the time of the injury (becoming dazed or confused). * Has current complaints of TBI symptoms such as headache, dizziness, or cognitive or affective problems that score at least 3 post-concussive symptoms as assessed by the OSU TBI-ID. * Has received current standard of care pharmacologic and nonpharmacologic interventions for TBI and any concomitant post traumatic stress disorder (PTSD) with no significant change in psychoactive therapy for at least 1 month. * Creatinine level that is less than or equal to the EACH laboratory's upper limit of normal. If the creatinine level exceeds the EACH laboratory's upper limit of normal, participants cannot have a CT scan due to risk of contrast dye-induced renal failure. Such participants may be randomized but must be approved by the Study Director.
Exclusion criteria
* Prisoners. * Pregnant Women. * Minors. * Individuals whose most recent TBI was sustained during illegal activity. * Potential active duty participants stationed \>1 hour outside the designated recruitment area of a participating local site will be excluded unless the command authorizes temporary relocation and appropriate relocation resources. * Potential Veteran participants who live \>1 hour outside the designated recruitment area of a participating local site, must be willing and able to travel to the local site to participate in all required local site visits without additional financial assistance than that which is described in the Veteran Payment Schedule (consent attachment C). * Active duty individuals with anticipated prolonged TAD/TDY or deployment within 6 months of study enrollment will be excluded. * Veterans with anticipated prolonged travel or relocation within 6 months of study enrollment will be excluded. An individual with any of the following characteristics will be excluded from this study based on contraindications to hyperbaric pressurization and hyperbaric oxygenation or other study assessment measures: * Women who are pregnant or who plan to become pregnant during the study period. * Women who are breastfeeding. * Women of childbearing potential who do not agree to practice an acceptable form of birth control during the study period. * Epilepsy or seizure disorder not stable on anticonvulsant therapy (stable defined as 6 months seizure-free). * Inability to protect airway or requires frequent suctioning. * Known or suspected perilymphatic fistula. * Presence of tracheostomy (due to limitations in autoinflation of the middle ear space). * Diabetes (risk of hypoglycemia). * Creatinine level that exceeds 1.5 times the EACH laboratory's upper limit of normal. * A diagnosis (from patient report or medical record evidence within one year) of untreated clinical hypo- or hyperthyroidism. * Allergy to iodine-based contrast dye (
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Summary of Treatment-Emergent Adverse Events | months 3, 6, 4, 5 and 7-12. Extended f/u up to 36 months | Safety was evaluated in-person during the first 3 months and at month 6, and via telephone follow-up calls at months 4, 5, and 7-12. Extended annual follow-up continued for up to 36 months through January 2016. |
| Summary of Study Intervention-Related Adverse Events | months 3, 6, 4, 5 and 7-12. Extended f/u up to 36 months | Safety was evaluated in-person during the first 3 months and at month 6, and via telephone follow-up calls at months 4, 5, and 7-12. Extended annual follow-up continued for up to 36 months through January 2016. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Presence of Post Concussion Symptoms Following Traumatic Brain Injury Using The Rivermead Post-Concussion Symptom Questionnaire (RPQ) - Change From Baseline (ITT Population) | Baseline to week 13, Months 6 and 12 | RPQ was created to measure the severity of post-concussion symptoms following traumatic brain injury. Scale compares any current symptoms to pre-injury levels to account for potential symptom exacerbation due to the TBI. The RPQ is the most commonly used clinical measure for mild TBI research because it is simple and reflects psychosocial function. The RPQ is intended to measure the presence and severity of 16 of the most commonly reported post-concussion symptoms found in the literature. The RPQ scale includes 16 common post-concussion symptom items whose responses range from 0= Not experienced at to 4= A severe problem. Total range is 0 to 64. The scores were derived by totaling the corresponding question scores for each domain and it's change from baseline. |
| Presence of Post Concussion Symptoms Following Traumatic Brain Injury Using The Rivermead Post-Concussion Symptom Questionnaire (RPQ3) - Change From Baseline (ITT Population) | Baseline to week 13, Months 6 and 12 | RPQ-3 was created to measure the severity of post-concussion symptoms following traumatic brain injury. Scale compares any current symptoms to pre-injury levels to account for potential symptom exacerbation due to the TBI. The RPQ is the most commonly used clinical measure for mild TBI research because it is simple and reflects psychosocial function. The RPQ is intended to measure the presence and severity of 16 of the most commonly reported post-concussion symptoms found in the literature. The RPQ scale includes 16 common post-concussion symptom items whose responses range from 0= Not experienced at to 4= A severe problem. Total range is 0 to 64. RPQ-3 ranges from 0-12 and access a subset of symptoms. Analyses of the RPQ-3 domain scores are presented separately. For the RPQ-3 total scales, the scores were derived by totaling the corresponding question scores for each domain and it's change from baseline. |
| Presence of Post Concussion Symptoms Following Traumatic Brain Injury Using The Rivermead Post-Concussion Symptom Questionnaire (RPQ13) - Change From Baseline (ITT Population) | Baseline to week 13, Months 6 and 12 | RPQ was created to measure the severity of post-concussion symptoms following traumatic brain injury. Scale compares any current symptoms to pre-injury levels to account for potential symptom exacerbation due to the TBI. The RPQ is the most commonly used clinical measure for mild TBI research because it is simple and reflects psychosocial function. The RPQ is intended to measure the presence and severity of 16 of the most commonly reported post-concussion symptoms found in the literature. The RPQ scale includes 16 common post-concussion symptom items whose responses range from 0= Not experienced at to 4= A severe problem. Total range is 0 to 64. RPQ-13 ranges from 0-52 and access's 13 remaining symptoms. Analyses of the RPQ-13 domain scores are presented separately. For RPQ-13 total scales, the scores were derived by totaling the corresponding question scores for each domain and change from baseline. |
| Presence of Post Concussion Symptoms Following Traumatic Brain Injury Using The Rivermead Post-Concussion Symptom Questionnaire (RPQ) - Change From Baseline (Per Protocol (PP) Population) | Baseline to week 13, Months 6 and 12 | RPQ was created to measure the severity of post-concussion symptoms following traumatic brain injury. Scale compares any current symptoms to pre-injury levels to account for potential symptom exacerbation due to the TBI. The RPQ is the most commonly used clinical measure for mild TBI research because it is simple and reflects psychosocial function. The RPQ is intended to measure the presence and severity of 16 of the most commonly reported post-concussion symptoms found in the literature. The RPQ scale includes 16 common post-concussion symptom items whose responses range from 0= Not experienced at to 4= A severe problem. Total range is 0 to 64. RPQ-3 ranges from 0-12 and access a subset of symptoms. For the RPQ total scales, the scores were derived by totaling the corresponding question scores for each domain and change from baseline. |
| Presence of Post Concussion Symptoms Following Traumatic Brain Injury Using The Rivermead Post-Concussion Symptom Questionnaire (RPQ, RPQ3 and RPQ13) - Baseline (ITT Population) | Baseline | RPQ/RPQ-3 was created to measure the severity of post-concussion symptoms following traumatic brain injury. Scale compares any current symptoms to pre-injury levels to account for potential symptom exacerbation due to the TBI. The RPQ is the most commonly used clinical measure for mild TBI research because it is simple and reflects psychosocial function. The RPQ is intended to measure the presence and severity of 16 of the most commonly reported post-concussion symptoms found in the literature. The RPQ scale includes 16 common post-concussion symptom items whose responses range from 0= Not experienced at to 4= A severe problem. Total range is 0 to 64. RPQ-3 ranges from 0-12 and access a subset of symptoms. RPQ-13 ranges from 0-52 and access's 13 remaining symptoms. Analyses of the RPQ-3 and RPQ-13 domain scores are presented separately. For each of the RPQ-3, RPQ-13, and RPQ total scales, the scores were derived by totaling the corresponding question scores for each domain. |
| Presence of Post Concussion Symptoms Following Traumatic Brain Injury Using The Rivermead Post-Concussion Symptom Questionnaire (RPQ13) - Change From Baseline (Per Protocol (PP) Population) | Baseline to week 13, Months 6 and 12 | RPQ was created to measure the severity of post-concussion symptoms following traumatic brain injury. Scale compares any current symptoms to pre-injury levels to account for potential symptom exacerbation due to the TBI. The RPQ is the most commonly used clinical measure for mild TBI research because it is simple and reflects psychosocial function. The RPQ is intended to measure the presence and severity of 16 of the most commonly reported post-concussion symptoms found in the literature. The RPQ scale includes 16 common post-concussion symptom items whose responses range from 0= Not experienced at to 4= A severe problem. RPQ-13 ranges from 0-52 and access's 13 remaining symptoms. Analyses of the RPQ-13 domain scores are presented separately. The scores were derived by totaling the corresponding question scores for each domain and change from baseline. |
| Presence of Post Concussion Symptoms Following Traumatic Brain Injury Using The Rivermead Post-Concussion Symptom Questionnaire (RPQ) - Change From Baseline: 24 and 36 Months (ITT Population) | Baseline to 24 months and 36 months | RPQ was created to measure the severity of post-concussion symptoms following traumatic brain injury. Scale compares any current symptoms to pre-injury levels to account for potential symptom exacerbation due to the TBI. The RPQ is the most commonly used clinical measure for mild TBI research because it is simple and reflects psychosocial function. The RPQ is intended to measure the presence and severity of 16 of the most commonly reported post-concussion symptoms found in the literature. The RPQ scale includes 16 common post-concussion symptom items whose responses range from 0= Not experienced at to 4= A severe problem. Total range is 0 to 64. For the RPQ total scales, the scores were derived by totaling the corresponding question scores for each domain and change from baseline. |
| Presence of Post Concussion Symptoms Following Traumatic Brain Injury Using The Rivermead Post-Concussion Symptom Questionnaire (RPQ3) - Change From Baseline: 24 and 36 Months (ITT Population) | Baseline to 24 months and 36 months | RPQ-3 was created to measure the severity of post-concussion symptoms following traumatic brain injury. Scale compares any current symptoms to pre-injury levels to account for potential symptom exacerbation due to the TBI. The RPQ is the most commonly used clinical measure for mild TBI research because it is simple and reflects psychosocial function. The RPQ is intended to measure the presence and severity of 16 of the most commonly reported post-concussion symptoms found in the literature. The RPQ scale includes 16 common post-concussion symptom items whose responses range from 0= Not experienced at to 4= A severe problem. Total range is 0 to 64. RPQ-3 ranges from 0-12 and access a subset of symptoms. Analyses of the RPQ-3 domain scores are presented separately. For the RPQ-3 total scales, the scores were derived by totaling the corresponding question scores for each domain and change from baseline. |
| Presence of Post Concussion Symptoms Following Traumatic Brain Injury Using The Rivermead Post-Concussion Symptom Questionnaire (RPQ13) - Change From Baseline: 24 and 36 Months (ITT Population) | Baseline to 24 months and 36 months | RPQ was created to measure the severity of post-concussion symptoms following traumatic brain injury. Scale compares any current symptoms to pre-injury levels to account for potential symptom exacerbation due to the TBI. The RPQ is the most commonly used clinical measure for mild TBI research because it is simple and reflects psychosocial function. The RPQ is intended to measure the presence and severity of 16 of the most commonly reported post-concussion symptoms found in the literature. The RPQ scale includes 16 common post-concussion symptom items whose responses range from 0= Not experienced at to 4= A severe problem. Total range is 0 to 64. RPQ-13 ranges from 0-52 and access's 13 remaining symptoms. Analyses of the RPQ-13 domain scores are presented separately. For RPQ-13 total scales, the scores were derived by totaling the corresponding question scores for each domain and change from baseline. |
| Presence of Post Concussion Symptoms Following Traumatic Brain Injury Using The Rivermead Post-Concussion Symptom Questionnaire (RPQ3) - Change From Baseline (Per Protocol (PP) Population) | Baseline to week 13, Months 6 and 12 | RPQ/RPQ-3 was created to measure the severity of post-concussion symptoms following traumatic brain injury. Scale compares any current symptoms to pre-injury levels to account for potential symptom exacerbation due to the TBI. The RPQ is the most commonly used clinical measure for mild TBI research because it is simple and reflects psychosocial function. The RPQ is intended to measure the presence and severity of 16 of the most commonly reported post-concussion symptoms found in the literature. The RPQ scale includes 16 common post-concussion symptom items whose responses range from 0= Not experienced at to 4= A severe problem. Total range is 0 to 64. RPQ-3 ranges from 0-12 and access a subset of symptoms. For the RPQ-3total scale, the scores were derived by totaling the corresponding question scores for each domain and change from baseline. |
| Presence of Post Concussion Symptoms Following Traumatic Brain Injury Using The Rivermead Post-Concussion Symptom Questionnaire (RPQ, RPQ3 and RPQ13) - Baseline (Per Protocol (PP) Population) | Baseline | RPQ/RPQ-3 was created to measure the severity of post-concussion symptoms following traumatic brain injury. Scale compares any current symptoms to pre-injury levels to account for potential symptom exacerbation due to the TBI. The RPQ is the most commonly used clinical measure for mild TBI research because it is simple and reflects psychosocial function. The RPQ is intended to measure the presence and severity of 16 of the most commonly reported post-concussion symptoms found in the literature. The RPQ scale includes 16 common post-concussion symptom items whose responses range from 0= Not experienced at to 4= A severe problem. Total range is 0 to 64. RPQ-3 ranges from 0-12 and access a subset of symptoms. RPQ-13 ranges from 0-52 and access's 13 remaining symptoms. Analyses of the RPQ-3 and RPQ-13 domain scores are presented separately. For each of the RPQ-3, RPQ-13, and RPQ total scales, the scores were derived by totaling the corresponding question scores for each domain. |
Countries
United States
Participant flow
Recruitment details
Participants were recruited from military sites from Sept 2012 to May 2014.
Participants by arm
| Arm | Count |
|---|---|
| HBO2 at 1.5 Atomspheres Absolute (ATA) Hyperbaric oxygen (HBO2) at 1.5 atms. Stratified by site and time from injury (less than one year versus one year or more), in which participants are randomized. Each participant will complete 40 sessions, one session per day, five sessions per week, within 12 weeks following randomization.
Hyperbaric oxygen (HBO2) at 1.5 atms: The Hyperbaric oxygen (HBO2) at 1.5 atms (active) group (hyperbaric oxygen-chamber compressed to 1.5 atm abs and breathing 100% oxygen). Each participant should complete 40 sessions over the course of 12 weeks, one session per day, five per week. | 36 |
| Sham Control (1.2 Atomspheres) Sham control 1.2 atms. Each participant will complete 40 sessions, one session per day, five sessions per week, within 12 weeks following randomization. Breathing air at a pressure of 1.2 atm abs is equivalent to inhaling 25% oxygen at sea level pressure (1.0 atm abs).
Sham control 1.2 atms: The chamber will be compressed with air to 1.2 atm abs to simulate the active group. Participants will don a hood and breathe 21% oxygen (room air). Each participant will complete 40 sessions, one session per day, five sessions per week, within 12 weeks following randomization. Breathing air at a pressure of 1.2 atm abs is equivalent to inhaling 25% oxygen at sea level pressure (1.0 atm abs). | 35 |
| Total | 71 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | drug use | 0 | 1 |
| Overall Study | Lost to Follow-up | 0 | 1 |
| Overall Study | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | Sham Control (1.2 Atomspheres) | Total | HBO2 at 1.5 Atomspheres Absolute (ATA) |
|---|---|---|---|
| Age, Continuous | 30.8 years STANDARD_DEVIATION 5.5 | 32.8 years STANDARD_DEVIATION 7.3 | 34.8 years STANDARD_DEVIATION 8.3 |
| Common Alternative Therapy Usage Counseling | 12 participants | 28 participants | 16 participants |
| Common Alternative Therapy Usage Physical therapy | 20 participants | 34 participants | 14 participants |
| Common Alternative Therapy Usage Psychotherapy | 7 participants | 19 participants | 12 participants |
| Common Medication Usage Daily pain medication | 21 participants | 43 participants | 22 participants |
| Common Medication Usage Episodic migraine medication | 14 participants | 30 participants | 16 participants |
| Common Medication Usage Fish oil or omega-3 fatty acid | 8 participants | 17 participants | 9 participants |
| Common Medication Usage Hypnotic or sleep aid | 15 participants | 31 participants | 16 participants |
| Common Medication Usage SSRI/SNRIs | 10 participants | 22 participants | 12 participants |
| Education College degree | 5 Participants | 16 Participants | 11 Participants |
| Education Graduare degree | 1 Participants | 6 Participants | 5 Participants |
| Education High school diploma | 6 Participants | 13 Participants | 7 Participants |
| Education Less than high school diploma | 0 Participants | 0 Participants | 0 Participants |
| Education Some college | 23 Participants | 36 Participants | 13 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 6 Participants | 13 Participants | 7 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 29 Participants | 58 Participants | 29 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Lifetime mTBI History Blast injuries | 8 Participants | 23 Participants | 15 Participants |
| Lifetime mTBI History Blunt force head injuries only | 7 Participants | 14 Participants | 7 Participants |
| Lifetime mTBI History Combination of blast and blunt force injuries | 20 Participants | 34 Participants | 14 Participants |
| Military Branch Army | 28 Participants | 55 Participants | 27 Participants |
| Military Branch Marines | 5 Participants | 12 Participants | 7 Participants |
| Military Branch Navy, Air Force, and Coast Guard | 2 Participants | 4 Participants | 2 Participants |
| Military Rank E1-E10 | 35 Participants | 66 Participants | 31 Participants |
| Military Rank O-1 to O-10/W-1 to W-5 | 0 Participants | 5 Participants | 5 Participants |
| Military Status Active duty | 33 Participants | 68 Participants | 35 Participants |
| Military Status Veteran | 2 Participants | 3 Participants | 1 Participants |
| Most Recent Qualifying Injury Blast injury | 23 Participants | 46 Participants | 23 Participants |
| Most Recent Qualifying Injury Blunt force head injury | 12 Participants | 25 Participants | 13 Participants |
| Most Recent Qualifying mTBI 3 Months to 1 Year >1year to 5 years | 27 Participants | 51 Participants | 24 Participants |
| Most Recent Qualifying mTBI 3 Months to 1 Year 3 months to 1 year | 8 Participants | 20 Participants | 12 Participants |
| Number of Combat Deployments | 2.2 deployments STANDARD_DEVIATION 1.7 | 2.8 deployments STANDARD_DEVIATION 2.4 | 3.4 deployments STANDARD_DEVIATION 2.8 |
| Number of Lifetime mTBIs | 3.7 mTBIs STANDARD_DEVIATION 2.3 | 3.6 mTBIs STANDARD_DEVIATION 2.8 | 3.6 mTBIs STANDARD_DEVIATION 3.2 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 4 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 2 Participants | 4 Participants | 2 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 3 Participants | 2 Participants |
| Race (NIH/OMB) White | 28 Participants | 58 Participants | 30 Participants |
| Region of Enrollment United States | 35 Participants | 71 Participants | 36 Participants |
| Sex: Female, Male Female | 1 Participants | 1 Participants | 0 Participants |
| Sex: Female, Male Male | 34 Participants | 70 Participants | 36 Participants |
| Time From Most Recent Qualifying Mild Traumatic Brain Injury (mTBI) | 25.5 months STANDARD_DEVIATION 15.4 | 25.6 months STANDARD_DEVIATION 16.2 | 25.6 months STANDARD_DEVIATION 17.1 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 36 | 0 / 35 |
| other Total, other adverse events | 35 / 36 | 34 / 35 |
| serious Total, serious adverse events | 5 / 36 | 3 / 35 |
Outcome results
Primary
Summary of Study Intervention-Related Adverse Events
Safety was evaluated in-person during the first 3 months and at month 6, and via telephone follow-up calls at months 4, 5, and 7-12. Extended annual follow-up continued for up to 36 months through January 2016.
Time frame: months 3, 6, 4, 5 and 7-12. Extended f/u up to 36 months
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| HBO2 at 1.5 Atomspheres Absolute (ATA) | Summary of Study Intervention-Related Adverse Events | Barotitis media | 11 Participants |
| HBO2 at 1.5 Atomspheres Absolute (ATA) | Summary of Study Intervention-Related Adverse Events | Dyspnea | 2 Participants |
| HBO2 at 1.5 Atomspheres Absolute (ATA) | Summary of Study Intervention-Related Adverse Events | Dizziness | 1 Participants |
| HBO2 at 1.5 Atomspheres Absolute (ATA) | Summary of Study Intervention-Related Adverse Events | Hyperventilation | 1 Participants |
| HBO2 at 1.5 Atomspheres Absolute (ATA) | Summary of Study Intervention-Related Adverse Events | Eye pruritus | 0 Participants |
| HBO2 at 1.5 Atomspheres Absolute (ATA) | Summary of Study Intervention-Related Adverse Events | Anxiety | 1 Participants |
| HBO2 at 1.5 Atomspheres Absolute (ATA) | Summary of Study Intervention-Related Adverse Events | Headache | 1 Participants |
| HBO2 at 1.5 Atomspheres Absolute (ATA) | Summary of Study Intervention-Related Adverse Events | Myopia | 1 Participants |
| HBO2 at 1.5 Atomspheres Absolute (ATA) | Summary of Study Intervention-Related Adverse Events | Sinus barotrauma | 5 Participants |
| HBO2 at 1.5 Atomspheres Absolute (ATA) | Summary of Study Intervention-Related Adverse Events | Vertigo | 1 Participants |
| HBO2 at 1.5 Atomspheres Absolute (ATA) | Summary of Study Intervention-Related Adverse Events | Somnolence | 1 Participants |
| Sham Control (1.2 Atomspheres) | Summary of Study Intervention-Related Adverse Events | Vertigo | 1 Participants |
| Sham Control (1.2 Atomspheres) | Summary of Study Intervention-Related Adverse Events | Barotitis media | 5 Participants |
| Sham Control (1.2 Atomspheres) | Summary of Study Intervention-Related Adverse Events | Sinus barotrauma | 4 Participants |
| Sham Control (1.2 Atomspheres) | Summary of Study Intervention-Related Adverse Events | Dizziness | 1 Participants |
| Sham Control (1.2 Atomspheres) | Summary of Study Intervention-Related Adverse Events | Headache | 2 Participants |
| Sham Control (1.2 Atomspheres) | Summary of Study Intervention-Related Adverse Events | Somnolence | 1 Participants |
| Sham Control (1.2 Atomspheres) | Summary of Study Intervention-Related Adverse Events | Dyspnea | 0 Participants |
| Sham Control (1.2 Atomspheres) | Summary of Study Intervention-Related Adverse Events | Hyperventilation | 0 Participants |
| Sham Control (1.2 Atomspheres) | Summary of Study Intervention-Related Adverse Events | Anxiety | 0 Participants |
| Sham Control (1.2 Atomspheres) | Summary of Study Intervention-Related Adverse Events | Myopia | 1 Participants |
| Sham Control (1.2 Atomspheres) | Summary of Study Intervention-Related Adverse Events | Eye pruritus | 1 Participants |
Primary
Summary of Treatment-Emergent Adverse Events
Safety was evaluated in-person during the first 3 months and at month 6, and via telephone follow-up calls at months 4, 5, and 7-12. Extended annual follow-up continued for up to 36 months through January 2016.
Time frame: months 3, 6, 4, 5 and 7-12. Extended f/u up to 36 months
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| HBO2 at 1.5 Atomspheres Absolute (ATA) | Summary of Treatment-Emergent Adverse Events | Sinus barotrauma | 5 Participants |
| HBO2 at 1.5 Atomspheres Absolute (ATA) | Summary of Treatment-Emergent Adverse Events | Sinus congestion | 2 Participants |
| HBO2 at 1.5 Atomspheres Absolute (ATA) | Summary of Treatment-Emergent Adverse Events | Sinusitis | 3 Participants |
| HBO2 at 1.5 Atomspheres Absolute (ATA) | Summary of Treatment-Emergent Adverse Events | Eye disorders | 10 Participants |
| HBO2 at 1.5 Atomspheres Absolute (ATA) | Summary of Treatment-Emergent Adverse Events | Ligament sprain | 0 Participants |
| HBO2 at 1.5 Atomspheres Absolute (ATA) | Summary of Treatment-Emergent Adverse Events | Nausea | 4 Participants |
| HBO2 at 1.5 Atomspheres Absolute (ATA) | Summary of Treatment-Emergent Adverse Events | Nasopharyngitis | 3 Participants |
| HBO2 at 1.5 Atomspheres Absolute (ATA) | Summary of Treatment-Emergent Adverse Events | Suicidal ideation | 2 Participants |
| HBO2 at 1.5 Atomspheres Absolute (ATA) | Summary of Treatment-Emergent Adverse Events | Contusion | 3 Participants |
| HBO2 at 1.5 Atomspheres Absolute (ATA) | Summary of Treatment-Emergent Adverse Events | Rash | 0 Participants |
| HBO2 at 1.5 Atomspheres Absolute (ATA) | Summary of Treatment-Emergent Adverse Events | Arthralgia | 4 Participants |
| HBO2 at 1.5 Atomspheres Absolute (ATA) | Summary of Treatment-Emergent Adverse Events | Investigations | 4 Participants |
| HBO2 at 1.5 Atomspheres Absolute (ATA) | Summary of Treatment-Emergent Adverse Events | Muscle strain | 1 Participants |
| HBO2 at 1.5 Atomspheres Absolute (ATA) | Summary of Treatment-Emergent Adverse Events | Vertigo | 3 Participants |
| HBO2 at 1.5 Atomspheres Absolute (ATA) | Summary of Treatment-Emergent Adverse Events | Back pain | 3 Participants |
| HBO2 at 1.5 Atomspheres Absolute (ATA) | Summary of Treatment-Emergent Adverse Events | General and administration site conditions | 3 Participants |
| HBO2 at 1.5 Atomspheres Absolute (ATA) | Summary of Treatment-Emergent Adverse Events | Barotitis media | 13 Participants |
| HBO2 at 1.5 Atomspheres Absolute (ATA) | Summary of Treatment-Emergent Adverse Events | Metabolism and nutrition disorders | 3 Participants |
| HBO2 at 1.5 Atomspheres Absolute (ATA) | Summary of Treatment-Emergent Adverse Events | Neck pain | 0 Participants |
| HBO2 at 1.5 Atomspheres Absolute (ATA) | Summary of Treatment-Emergent Adverse Events | Renal and urinary disorders | 3 Participants |
| HBO2 at 1.5 Atomspheres Absolute (ATA) | Summary of Treatment-Emergent Adverse Events | Upper respiratory tract infection | 13 Participants |
| HBO2 at 1.5 Atomspheres Absolute (ATA) | Summary of Treatment-Emergent Adverse Events | Vascular disorders | 3 Participants |
| HBO2 at 1.5 Atomspheres Absolute (ATA) | Summary of Treatment-Emergent Adverse Events | Dizziness | 5 Participants |
| HBO2 at 1.5 Atomspheres Absolute (ATA) | Summary of Treatment-Emergent Adverse Events | Congenital, familial and genetic disorders | 1 Participants |
| HBO2 at 1.5 Atomspheres Absolute (ATA) | Summary of Treatment-Emergent Adverse Events | Nasal congestion | 5 Participants |
| HBO2 at 1.5 Atomspheres Absolute (ATA) | Summary of Treatment-Emergent Adverse Events | Endocrine disorders | 1 Participants |
| HBO2 at 1.5 Atomspheres Absolute (ATA) | Summary of Treatment-Emergent Adverse Events | Headache | 4 Participants |
| HBO2 at 1.5 Atomspheres Absolute (ATA) | Summary of Treatment-Emergent Adverse Events | Hepatobiliary disorders | 1 Participants |
| HBO2 at 1.5 Atomspheres Absolute (ATA) | Summary of Treatment-Emergent Adverse Events | Dyspnea | 4 Participants |
| HBO2 at 1.5 Atomspheres Absolute (ATA) | Summary of Treatment-Emergent Adverse Events | Immune system disorders | 0 Participants |
| HBO2 at 1.5 Atomspheres Absolute (ATA) | Summary of Treatment-Emergent Adverse Events | Gastroenteritis | 1 Participants |
| HBO2 at 1.5 Atomspheres Absolute (ATA) | Summary of Treatment-Emergent Adverse Events | Neoplasms benign, malignant and unspecified | 0 Participants |
| HBO2 at 1.5 Atomspheres Absolute (ATA) | Summary of Treatment-Emergent Adverse Events | Epistaxis | 2 Participants |
| Sham Control (1.2 Atomspheres) | Summary of Treatment-Emergent Adverse Events | Neoplasms benign, malignant and unspecified | 1 Participants |
| Sham Control (1.2 Atomspheres) | Summary of Treatment-Emergent Adverse Events | Contusion | 3 Participants |
| Sham Control (1.2 Atomspheres) | Summary of Treatment-Emergent Adverse Events | Headache | 2 Participants |
| Sham Control (1.2 Atomspheres) | Summary of Treatment-Emergent Adverse Events | Nasal congestion | 3 Participants |
| Sham Control (1.2 Atomspheres) | Summary of Treatment-Emergent Adverse Events | Barotitis media | 5 Participants |
| Sham Control (1.2 Atomspheres) | Summary of Treatment-Emergent Adverse Events | Ligament sprain | 5 Participants |
| Sham Control (1.2 Atomspheres) | Summary of Treatment-Emergent Adverse Events | Muscle strain | 3 Participants |
| Sham Control (1.2 Atomspheres) | Summary of Treatment-Emergent Adverse Events | Upper respiratory tract infection | 9 Participants |
| Sham Control (1.2 Atomspheres) | Summary of Treatment-Emergent Adverse Events | Gastroenteritis | 5 Participants |
| Sham Control (1.2 Atomspheres) | Summary of Treatment-Emergent Adverse Events | Sinusitis | 4 Participants |
| Sham Control (1.2 Atomspheres) | Summary of Treatment-Emergent Adverse Events | Nasopharyngitis | 2 Participants |
| Sham Control (1.2 Atomspheres) | Summary of Treatment-Emergent Adverse Events | Arthralgia | 2 Participants |
| Sham Control (1.2 Atomspheres) | Summary of Treatment-Emergent Adverse Events | Back pain | 2 Participants |
| Sham Control (1.2 Atomspheres) | Summary of Treatment-Emergent Adverse Events | Neck pain | 4 Participants |
| Sham Control (1.2 Atomspheres) | Summary of Treatment-Emergent Adverse Events | Dizziness | 1 Participants |
| Sham Control (1.2 Atomspheres) | Summary of Treatment-Emergent Adverse Events | Dyspnea | 1 Participants |
| Sham Control (1.2 Atomspheres) | Summary of Treatment-Emergent Adverse Events | Epistaxis | 2 Participants |
| Sham Control (1.2 Atomspheres) | Summary of Treatment-Emergent Adverse Events | Sinus congestion | 2 Participants |
| Sham Control (1.2 Atomspheres) | Summary of Treatment-Emergent Adverse Events | Eye disorders | 7 Participants |
| Sham Control (1.2 Atomspheres) | Summary of Treatment-Emergent Adverse Events | Nausea | 1 Participants |
| Sham Control (1.2 Atomspheres) | Summary of Treatment-Emergent Adverse Events | Suicidal ideation | 2 Participants |
| Sham Control (1.2 Atomspheres) | Summary of Treatment-Emergent Adverse Events | Rash | 3 Participants |
| Sham Control (1.2 Atomspheres) | Summary of Treatment-Emergent Adverse Events | Investigations | 3 Participants |
| Sham Control (1.2 Atomspheres) | Summary of Treatment-Emergent Adverse Events | Vertigo | 3 Participants |
| Sham Control (1.2 Atomspheres) | Summary of Treatment-Emergent Adverse Events | General and administration site conditions | 1 Participants |
| Sham Control (1.2 Atomspheres) | Summary of Treatment-Emergent Adverse Events | Metabolism and nutrition disorders | 2 Participants |
| Sham Control (1.2 Atomspheres) | Summary of Treatment-Emergent Adverse Events | Renal and urinary disorders | 0 Participants |
| Sham Control (1.2 Atomspheres) | Summary of Treatment-Emergent Adverse Events | Vascular disorders | 0 Participants |
| Sham Control (1.2 Atomspheres) | Summary of Treatment-Emergent Adverse Events | Congenital, familial and genetic disorders | 0 Participants |
| Sham Control (1.2 Atomspheres) | Summary of Treatment-Emergent Adverse Events | Endocrine disorders | 0 Participants |
| Sham Control (1.2 Atomspheres) | Summary of Treatment-Emergent Adverse Events | Hepatobiliary disorders | 0 Participants |
| Sham Control (1.2 Atomspheres) | Summary of Treatment-Emergent Adverse Events | Immune system disorders | 1 Participants |
| Sham Control (1.2 Atomspheres) | Summary of Treatment-Emergent Adverse Events | Sinus barotrauma | 3 Participants |
Secondary
Presence of Post Concussion Symptoms Following Traumatic Brain Injury Using The Rivermead Post-Concussion Symptom Questionnaire (RPQ13) - Change From Baseline: 24 and 36 Months (ITT Population)
RPQ was created to measure the severity of post-concussion symptoms following traumatic brain injury. Scale compares any current symptoms to pre-injury levels to account for potential symptom exacerbation due to the TBI. The RPQ is the most commonly used clinical measure for mild TBI research because it is simple and reflects psychosocial function. The RPQ is intended to measure the presence and severity of 16 of the most commonly reported post-concussion symptoms found in the literature. The RPQ scale includes 16 common post-concussion symptom items whose responses range from 0= Not experienced at to 4= A severe problem. Total range is 0 to 64. RPQ-13 ranges from 0-52 and access's 13 remaining symptoms. Analyses of the RPQ-13 domain scores are presented separately. For RPQ-13 total scales, the scores were derived by totaling the corresponding question scores for each domain and change from baseline.
Time frame: Baseline to 24 months and 36 months
Population: HBO2: 25 subs consented to 24 and 36 month f/u; 23 subs completed month 24 and 9 completed month 36; 2 subs missed 24 month visit.~Sham: 17 subs consented to 24 and 36 month f/u. 17 completed month 24 and 5 completed month 36
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HBO2 at 1.5 Atomspheres Absolute (ATA) | Presence of Post Concussion Symptoms Following Traumatic Brain Injury Using The Rivermead Post-Concussion Symptom Questionnaire (RPQ13) - Change From Baseline: 24 and 36 Months (ITT Population) | Baseline to 24 months | 1.4 RPQ scores | Standard Deviation 16.1 |
| HBO2 at 1.5 Atomspheres Absolute (ATA) | Presence of Post Concussion Symptoms Following Traumatic Brain Injury Using The Rivermead Post-Concussion Symptom Questionnaire (RPQ13) - Change From Baseline: 24 and 36 Months (ITT Population) | Baseline to 36 months | 2.0 RPQ scores | Standard Deviation 7.5 |
| Sham Control (1.2 Atomspheres) | Presence of Post Concussion Symptoms Following Traumatic Brain Injury Using The Rivermead Post-Concussion Symptom Questionnaire (RPQ13) - Change From Baseline: 24 and 36 Months (ITT Population) | Baseline to 24 months | 3.0 RPQ scores | Standard Deviation 9.5 |
| Sham Control (1.2 Atomspheres) | Presence of Post Concussion Symptoms Following Traumatic Brain Injury Using The Rivermead Post-Concussion Symptom Questionnaire (RPQ13) - Change From Baseline: 24 and 36 Months (ITT Population) | Baseline to 36 months | 3.8 RPQ scores | Standard Deviation 16.8 |
Secondary
Presence of Post Concussion Symptoms Following Traumatic Brain Injury Using The Rivermead Post-Concussion Symptom Questionnaire (RPQ13) - Change From Baseline (ITT Population)
RPQ was created to measure the severity of post-concussion symptoms following traumatic brain injury. Scale compares any current symptoms to pre-injury levels to account for potential symptom exacerbation due to the TBI. The RPQ is the most commonly used clinical measure for mild TBI research because it is simple and reflects psychosocial function. The RPQ is intended to measure the presence and severity of 16 of the most commonly reported post-concussion symptoms found in the literature. The RPQ scale includes 16 common post-concussion symptom items whose responses range from 0= Not experienced at to 4= A severe problem. Total range is 0 to 64. RPQ-13 ranges from 0-52 and access's 13 remaining symptoms. Analyses of the RPQ-13 domain scores are presented separately. For RPQ-13 total scales, the scores were derived by totaling the corresponding question scores for each domain and change from baseline.
Time frame: Baseline to week 13, Months 6 and 12
Population: 1 subject in HBO2 missed the 6 month visit and 2 subjects missed the 12 month visit. 1 subject in the sham missed the week 13 visit and, 1 subject missed the month 6 visit and 3 subjects withdrew by month 12
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HBO2 at 1.5 Atomspheres Absolute (ATA) | Presence of Post Concussion Symptoms Following Traumatic Brain Injury Using The Rivermead Post-Concussion Symptom Questionnaire (RPQ13) - Change From Baseline (ITT Population) | Week 13 change score | -0.4 RPQ scores | Standard Deviation 12.3 |
| HBO2 at 1.5 Atomspheres Absolute (ATA) | Presence of Post Concussion Symptoms Following Traumatic Brain Injury Using The Rivermead Post-Concussion Symptom Questionnaire (RPQ13) - Change From Baseline (ITT Population) | Month 6 change score | -3.0 RPQ scores | Standard Deviation 11.9 |
| HBO2 at 1.5 Atomspheres Absolute (ATA) | Presence of Post Concussion Symptoms Following Traumatic Brain Injury Using The Rivermead Post-Concussion Symptom Questionnaire (RPQ13) - Change From Baseline (ITT Population) | Month 12 change score | 5.2 RPQ scores | Standard Deviation 12.7 |
| Sham Control (1.2 Atomspheres) | Presence of Post Concussion Symptoms Following Traumatic Brain Injury Using The Rivermead Post-Concussion Symptom Questionnaire (RPQ13) - Change From Baseline (ITT Population) | Week 13 change score | 4.7 RPQ scores | Standard Deviation 11.1 |
| Sham Control (1.2 Atomspheres) | Presence of Post Concussion Symptoms Following Traumatic Brain Injury Using The Rivermead Post-Concussion Symptom Questionnaire (RPQ13) - Change From Baseline (ITT Population) | Month 6 change score | 2.3 RPQ scores | Standard Deviation 9.9 |
| Sham Control (1.2 Atomspheres) | Presence of Post Concussion Symptoms Following Traumatic Brain Injury Using The Rivermead Post-Concussion Symptom Questionnaire (RPQ13) - Change From Baseline (ITT Population) | Month 12 change score | 5.0 RPQ scores | Standard Deviation 10.4 |
Secondary
Presence of Post Concussion Symptoms Following Traumatic Brain Injury Using The Rivermead Post-Concussion Symptom Questionnaire (RPQ13) - Change From Baseline (Per Protocol (PP) Population)
RPQ was created to measure the severity of post-concussion symptoms following traumatic brain injury. Scale compares any current symptoms to pre-injury levels to account for potential symptom exacerbation due to the TBI. The RPQ is the most commonly used clinical measure for mild TBI research because it is simple and reflects psychosocial function. The RPQ is intended to measure the presence and severity of 16 of the most commonly reported post-concussion symptoms found in the literature. The RPQ scale includes 16 common post-concussion symptom items whose responses range from 0= Not experienced at to 4= A severe problem. Total range is 0 to 64. RPQ-13 ranges from 0-52 and access's 13 remaining symptoms. Analyses of the RPQ-13 domain scores are presented separately. For RPQ-13 total scales, the scores were derived by totaling the corresponding question scores for each domain change from baseline.
Time frame: Baseline to month 24 and month 36
Population: PP was defined as subs who completed 20 chamber sessions and week13 f/u. PP was also restricted to subs who didn't report illicit drug use following randomization. 67 subs satisfied the PP, 35/36 HBO2 and 32/35 sham. 4 were excluded from the PP population, 3 excluded because they completed \<20 sessions,1 because of illicit drug use during study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HBO2 at 1.5 Atomspheres Absolute (ATA) | Presence of Post Concussion Symptoms Following Traumatic Brain Injury Using The Rivermead Post-Concussion Symptom Questionnaire (RPQ13) - Change From Baseline (Per Protocol (PP) Population) | Baseline to month 24 | 1.4 RPQ scores | Standard Deviation 16.1 |
| HBO2 at 1.5 Atomspheres Absolute (ATA) | Presence of Post Concussion Symptoms Following Traumatic Brain Injury Using The Rivermead Post-Concussion Symptom Questionnaire (RPQ13) - Change From Baseline (Per Protocol (PP) Population) | Baseline to month 36 | 2.0 RPQ scores | Standard Deviation 7.5 |
| Sham Control (1.2 Atomspheres) | Presence of Post Concussion Symptoms Following Traumatic Brain Injury Using The Rivermead Post-Concussion Symptom Questionnaire (RPQ13) - Change From Baseline (Per Protocol (PP) Population) | Baseline to month 24 | 3.0 RPQ scores | Standard Deviation 9.5 |
| Sham Control (1.2 Atomspheres) | Presence of Post Concussion Symptoms Following Traumatic Brain Injury Using The Rivermead Post-Concussion Symptom Questionnaire (RPQ13) - Change From Baseline (Per Protocol (PP) Population) | Baseline to month 36 | 3.8 RPQ scores | Standard Deviation 16.8 |
Secondary
Presence of Post Concussion Symptoms Following Traumatic Brain Injury Using The Rivermead Post-Concussion Symptom Questionnaire (RPQ13) - Change From Baseline (Per Protocol (PP) Population)
RPQ was created to measure the severity of post-concussion symptoms following traumatic brain injury. Scale compares any current symptoms to pre-injury levels to account for potential symptom exacerbation due to the TBI. The RPQ is the most commonly used clinical measure for mild TBI research because it is simple and reflects psychosocial function. The RPQ is intended to measure the presence and severity of 16 of the most commonly reported post-concussion symptoms found in the literature. The RPQ scale includes 16 common post-concussion symptom items whose responses range from 0= Not experienced at to 4= A severe problem. RPQ-13 ranges from 0-52 and access's 13 remaining symptoms. Analyses of the RPQ-13 domain scores are presented separately. The scores were derived by totaling the corresponding question scores for each domain and change from baseline.
Time frame: Baseline to week 13, Months 6 and 12
Population: PP was defined as subs who completed 20 chamber sessions and week13 f/u. PP was also restricted to subs who didn't report illicit drug use following randomization. 67 subs satisfied the PP, 35/36 HBO2 and 32/35 sham. 4 were excluded from the PP population, 3 excluded because they completed \<20 sessions,1 because of illicit drug use during study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HBO2 at 1.5 Atomspheres Absolute (ATA) | Presence of Post Concussion Symptoms Following Traumatic Brain Injury Using The Rivermead Post-Concussion Symptom Questionnaire (RPQ13) - Change From Baseline (Per Protocol (PP) Population) | Week 13 change score | -0.7 RPQ scores | Standard Deviation 12.4 |
| HBO2 at 1.5 Atomspheres Absolute (ATA) | Presence of Post Concussion Symptoms Following Traumatic Brain Injury Using The Rivermead Post-Concussion Symptom Questionnaire (RPQ13) - Change From Baseline (Per Protocol (PP) Population) | Month 6 change score | -3.0 RPQ scores | Standard Deviation 11.9 |
| HBO2 at 1.5 Atomspheres Absolute (ATA) | Presence of Post Concussion Symptoms Following Traumatic Brain Injury Using The Rivermead Post-Concussion Symptom Questionnaire (RPQ13) - Change From Baseline (Per Protocol (PP) Population) | Month 12 change score | 5.4 RPQ scores | Standard Deviation 12.8 |
| Sham Control (1.2 Atomspheres) | Presence of Post Concussion Symptoms Following Traumatic Brain Injury Using The Rivermead Post-Concussion Symptom Questionnaire (RPQ13) - Change From Baseline (Per Protocol (PP) Population) | Week 13 change score | 4.9 RPQ scores | Standard Deviation 11.2 |
| Sham Control (1.2 Atomspheres) | Presence of Post Concussion Symptoms Following Traumatic Brain Injury Using The Rivermead Post-Concussion Symptom Questionnaire (RPQ13) - Change From Baseline (Per Protocol (PP) Population) | Month 6 change score | 2.9 RPQ scores | Standard Deviation 9.5 |
| Sham Control (1.2 Atomspheres) | Presence of Post Concussion Symptoms Following Traumatic Brain Injury Using The Rivermead Post-Concussion Symptom Questionnaire (RPQ13) - Change From Baseline (Per Protocol (PP) Population) | Month 12 change score | 5.1 RPQ scores | Standard Deviation 10.6 |
Secondary
Presence of Post Concussion Symptoms Following Traumatic Brain Injury Using The Rivermead Post-Concussion Symptom Questionnaire (RPQ3) - Change From Baseline: 24 and 36 Months (ITT Population)
RPQ-3 was created to measure the severity of post-concussion symptoms following traumatic brain injury. Scale compares any current symptoms to pre-injury levels to account for potential symptom exacerbation due to the TBI. The RPQ is the most commonly used clinical measure for mild TBI research because it is simple and reflects psychosocial function. The RPQ is intended to measure the presence and severity of 16 of the most commonly reported post-concussion symptoms found in the literature. The RPQ scale includes 16 common post-concussion symptom items whose responses range from 0= Not experienced at to 4= A severe problem. Total range is 0 to 64. RPQ-3 ranges from 0-12 and access a subset of symptoms. Analyses of the RPQ-3 domain scores are presented separately. For the RPQ-3 total scales, the scores were derived by totaling the corresponding question scores for each domain and change from baseline.
Time frame: Baseline to 24 months and 36 months
Population: HBO2: 25 subs consented to 24 and 36 month f/u; 23 subs completed month 24 and 9 completed month 36; 2 subs missed 24 month visit.~Sham: 17 subs consented to 24 and 36 month f/u. 17 completed month 24 and 5 completed month 36
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HBO2 at 1.5 Atomspheres Absolute (ATA) | Presence of Post Concussion Symptoms Following Traumatic Brain Injury Using The Rivermead Post-Concussion Symptom Questionnaire (RPQ3) - Change From Baseline: 24 and 36 Months (ITT Population) | Baseline to 24 months | -0.2 RPQ scores | Standard Deviation 3.2 |
| HBO2 at 1.5 Atomspheres Absolute (ATA) | Presence of Post Concussion Symptoms Following Traumatic Brain Injury Using The Rivermead Post-Concussion Symptom Questionnaire (RPQ3) - Change From Baseline: 24 and 36 Months (ITT Population) | Baseline to 36 months | -0.9 RPQ scores | Standard Deviation 2.9 |
| Sham Control (1.2 Atomspheres) | Presence of Post Concussion Symptoms Following Traumatic Brain Injury Using The Rivermead Post-Concussion Symptom Questionnaire (RPQ3) - Change From Baseline: 24 and 36 Months (ITT Population) | Baseline to 24 months | -0.1 RPQ scores | Standard Deviation 2.7 |
| Sham Control (1.2 Atomspheres) | Presence of Post Concussion Symptoms Following Traumatic Brain Injury Using The Rivermead Post-Concussion Symptom Questionnaire (RPQ3) - Change From Baseline: 24 and 36 Months (ITT Population) | Baseline to 36 months | 0.8 RPQ scores | Standard Deviation 3 |
Secondary
Presence of Post Concussion Symptoms Following Traumatic Brain Injury Using The Rivermead Post-Concussion Symptom Questionnaire (RPQ3) - Change From Baseline (ITT Population)
RPQ-3 was created to measure the severity of post-concussion symptoms following traumatic brain injury. Scale compares any current symptoms to pre-injury levels to account for potential symptom exacerbation due to the TBI. The RPQ is the most commonly used clinical measure for mild TBI research because it is simple and reflects psychosocial function. The RPQ is intended to measure the presence and severity of 16 of the most commonly reported post-concussion symptoms found in the literature. The RPQ scale includes 16 common post-concussion symptom items whose responses range from 0= Not experienced at to 4= A severe problem. Total range is 0 to 64. RPQ-3 ranges from 0-12 and access a subset of symptoms. Analyses of the RPQ-3 domain scores are presented separately. For the RPQ-3 total scales, the scores were derived by totaling the corresponding question scores for each domain and it's change from baseline.
Time frame: Baseline to week 13, Months 6 and 12
Population: 1 subject in HBO2 missed the 6 month visit and 2 subjects missed the 12 month visit. 1 subject in the sham missed the week 13 visit and, 1 subject missed the month 6 visit and 3 subjects withdrew by month 12
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HBO2 at 1.5 Atomspheres Absolute (ATA) | Presence of Post Concussion Symptoms Following Traumatic Brain Injury Using The Rivermead Post-Concussion Symptom Questionnaire (RPQ3) - Change From Baseline (ITT Population) | Week 13 change score | -0.3 RPQ scores | Standard Deviation 2.7 |
| HBO2 at 1.5 Atomspheres Absolute (ATA) | Presence of Post Concussion Symptoms Following Traumatic Brain Injury Using The Rivermead Post-Concussion Symptom Questionnaire (RPQ3) - Change From Baseline (ITT Population) | Month 6 change score | -1.4 RPQ scores | Standard Deviation 2.7 |
| HBO2 at 1.5 Atomspheres Absolute (ATA) | Presence of Post Concussion Symptoms Following Traumatic Brain Injury Using The Rivermead Post-Concussion Symptom Questionnaire (RPQ3) - Change From Baseline (ITT Population) | Month 12 change score | 0.5 RPQ scores | Standard Deviation 2.9 |
| Sham Control (1.2 Atomspheres) | Presence of Post Concussion Symptoms Following Traumatic Brain Injury Using The Rivermead Post-Concussion Symptom Questionnaire (RPQ3) - Change From Baseline (ITT Population) | Week 13 change score | 1.2 RPQ scores | Standard Deviation 2.2 |
| Sham Control (1.2 Atomspheres) | Presence of Post Concussion Symptoms Following Traumatic Brain Injury Using The Rivermead Post-Concussion Symptom Questionnaire (RPQ3) - Change From Baseline (ITT Population) | Month 6 change score | 0.3 RPQ scores | Standard Deviation 2.2 |
| Sham Control (1.2 Atomspheres) | Presence of Post Concussion Symptoms Following Traumatic Brain Injury Using The Rivermead Post-Concussion Symptom Questionnaire (RPQ3) - Change From Baseline (ITT Population) | Month 12 change score | 0.5 RPQ scores | Standard Deviation 2.6 |
Secondary
Presence of Post Concussion Symptoms Following Traumatic Brain Injury Using The Rivermead Post-Concussion Symptom Questionnaire (RPQ3) - Change From Baseline (Per Protocol (PP) Population)
RPQ-3 was created to measure the severity of post-concussion symptoms following traumatic brain injury. Scale compares any current symptoms to pre-injury levels to account for potential symptom exacerbation due to the TBI. The RPQ is the most commonly used clinical measure for mild TBI research because it is simple and reflects psychosocial function. The RPQ is intended to measure the presence and severity of 16 of the most commonly reported post-concussion symptoms found in the literature. The RPQ scale includes 16 common post-concussion symptom items whose responses range from 0= Not experienced at to 4= A severe problem. Total range is 0 to 64. RPQ-3 ranges from 0-12 and access a subset of symptoms. Analyses of the RPQ-3 domain scores are presented separately. For the RPQ-3 total scales, the scores were derived by totaling the corresponding question scores for each domain and change from baseline.
Time frame: Baseline to month 24 and month 36
Population: PP was defined as subs who completed 20 chamber sessions and week13 f/u. PP was also restricted to subs who didn't report illicit drug use following randomization. 67 subs satisfied the PP, 35/36 HBO2 and 32/35 sham. 4 were excluded from the PP population, 3 excluded because they completed \<20 sessions,1 because of illicit drug use during study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HBO2 at 1.5 Atomspheres Absolute (ATA) | Presence of Post Concussion Symptoms Following Traumatic Brain Injury Using The Rivermead Post-Concussion Symptom Questionnaire (RPQ3) - Change From Baseline (Per Protocol (PP) Population) | Baseline to month 24 | -0.2 RPQ scores | Standard Deviation 3.2 |
| HBO2 at 1.5 Atomspheres Absolute (ATA) | Presence of Post Concussion Symptoms Following Traumatic Brain Injury Using The Rivermead Post-Concussion Symptom Questionnaire (RPQ3) - Change From Baseline (Per Protocol (PP) Population) | Baseline to month 36 | -0.9 RPQ scores | Standard Deviation 2.9 |
| Sham Control (1.2 Atomspheres) | Presence of Post Concussion Symptoms Following Traumatic Brain Injury Using The Rivermead Post-Concussion Symptom Questionnaire (RPQ3) - Change From Baseline (Per Protocol (PP) Population) | Baseline to month 24 | -0.1 RPQ scores | Standard Deviation 2.7 |
| Sham Control (1.2 Atomspheres) | Presence of Post Concussion Symptoms Following Traumatic Brain Injury Using The Rivermead Post-Concussion Symptom Questionnaire (RPQ3) - Change From Baseline (Per Protocol (PP) Population) | Baseline to month 36 | 0.8 RPQ scores | Standard Deviation 3 |
Secondary
Presence of Post Concussion Symptoms Following Traumatic Brain Injury Using The Rivermead Post-Concussion Symptom Questionnaire (RPQ3) - Change From Baseline (Per Protocol (PP) Population)
RPQ/RPQ-3 was created to measure the severity of post-concussion symptoms following traumatic brain injury. Scale compares any current symptoms to pre-injury levels to account for potential symptom exacerbation due to the TBI. The RPQ is the most commonly used clinical measure for mild TBI research because it is simple and reflects psychosocial function. The RPQ is intended to measure the presence and severity of 16 of the most commonly reported post-concussion symptoms found in the literature. The RPQ scale includes 16 common post-concussion symptom items whose responses range from 0= Not experienced at to 4= A severe problem. Total range is 0 to 64. RPQ-3 ranges from 0-12 and access a subset of symptoms. For the RPQ-3total scale, the scores were derived by totaling the corresponding question scores for each domain and change from baseline.
Time frame: Baseline to week 13, Months 6 and 12
Population: PP was defined as subs who completed 20 chamber sessions and week13 f/u. PP was also restricted to subs who didn't report illicit drug use following randomization. 67 subs satisfied the PP, 35/36 HBO2 and 32/35 sham. 4 were excluded from the PP population, 3 excluded because they completed \<20 sessions,1 because of illicit drug use during study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HBO2 at 1.5 Atomspheres Absolute (ATA) | Presence of Post Concussion Symptoms Following Traumatic Brain Injury Using The Rivermead Post-Concussion Symptom Questionnaire (RPQ3) - Change From Baseline (Per Protocol (PP) Population) | Week 13 change score | -0.4 RPQ scores | Standard Deviation 2.8 |
| HBO2 at 1.5 Atomspheres Absolute (ATA) | Presence of Post Concussion Symptoms Following Traumatic Brain Injury Using The Rivermead Post-Concussion Symptom Questionnaire (RPQ3) - Change From Baseline (Per Protocol (PP) Population) | Month 6 change score | -1.4 RPQ scores | Standard Deviation 2.7 |
| HBO2 at 1.5 Atomspheres Absolute (ATA) | Presence of Post Concussion Symptoms Following Traumatic Brain Injury Using The Rivermead Post-Concussion Symptom Questionnaire (RPQ3) - Change From Baseline (Per Protocol (PP) Population) | Month 12 change score | 0.4 RPQ scores | Standard Deviation 2.9 |
| Sham Control (1.2 Atomspheres) | Presence of Post Concussion Symptoms Following Traumatic Brain Injury Using The Rivermead Post-Concussion Symptom Questionnaire (RPQ3) - Change From Baseline (Per Protocol (PP) Population) | Week 13 change score | 1.2 RPQ scores | Standard Deviation 2.3 |
| Sham Control (1.2 Atomspheres) | Presence of Post Concussion Symptoms Following Traumatic Brain Injury Using The Rivermead Post-Concussion Symptom Questionnaire (RPQ3) - Change From Baseline (Per Protocol (PP) Population) | Month 6 change score | 0.3 RPQ scores | Standard Deviation 2.2 |
| Sham Control (1.2 Atomspheres) | Presence of Post Concussion Symptoms Following Traumatic Brain Injury Using The Rivermead Post-Concussion Symptom Questionnaire (RPQ3) - Change From Baseline (Per Protocol (PP) Population) | Month 12 change score | 0.5 RPQ scores | Standard Deviation 2.7 |
Secondary
Presence of Post Concussion Symptoms Following Traumatic Brain Injury Using The Rivermead Post-Concussion Symptom Questionnaire (RPQ) - Change From Baseline: 24 and 36 Months (ITT Population)
RPQ was created to measure the severity of post-concussion symptoms following traumatic brain injury. Scale compares any current symptoms to pre-injury levels to account for potential symptom exacerbation due to the TBI. The RPQ is the most commonly used clinical measure for mild TBI research because it is simple and reflects psychosocial function. The RPQ is intended to measure the presence and severity of 16 of the most commonly reported post-concussion symptoms found in the literature. The RPQ scale includes 16 common post-concussion symptom items whose responses range from 0= Not experienced at to 4= A severe problem. Total range is 0 to 64. For the RPQ total scales, the scores were derived by totaling the corresponding question scores for each domain and change from baseline.
Time frame: Baseline to 24 months and 36 months
Population: HBO2: 25 subs consented to 24 and 36 month f/u; 23 subs completed month 24 and 9 completed month 36; 2 subs missed 24 month visit.~Sham: 17 subs consented to 24 and 36 month f/u. 17 completed month 24 and 5 completed month 36
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HBO2 at 1.5 Atomspheres Absolute (ATA) | Presence of Post Concussion Symptoms Following Traumatic Brain Injury Using The Rivermead Post-Concussion Symptom Questionnaire (RPQ) - Change From Baseline: 24 and 36 Months (ITT Population) | Baseline to 24 months | 1.2 RPQ scores | Standard Deviation 18.5 |
| HBO2 at 1.5 Atomspheres Absolute (ATA) | Presence of Post Concussion Symptoms Following Traumatic Brain Injury Using The Rivermead Post-Concussion Symptom Questionnaire (RPQ) - Change From Baseline: 24 and 36 Months (ITT Population) | Baseline to 36 months | 1.4 RPQ scores | Standard Deviation 9 |
| Sham Control (1.2 Atomspheres) | Presence of Post Concussion Symptoms Following Traumatic Brain Injury Using The Rivermead Post-Concussion Symptom Questionnaire (RPQ) - Change From Baseline: 24 and 36 Months (ITT Population) | Baseline to 24 months | 2.9 RPQ scores | Standard Deviation 11.9 |
| Sham Control (1.2 Atomspheres) | Presence of Post Concussion Symptoms Following Traumatic Brain Injury Using The Rivermead Post-Concussion Symptom Questionnaire (RPQ) - Change From Baseline: 24 and 36 Months (ITT Population) | Baseline to 36 months | 4.6 RPQ scores | Standard Deviation 19.6 |
Secondary
Presence of Post Concussion Symptoms Following Traumatic Brain Injury Using The Rivermead Post-Concussion Symptom Questionnaire (RPQ) - Change From Baseline (ITT Population)
RPQ was created to measure the severity of post-concussion symptoms following traumatic brain injury. Scale compares any current symptoms to pre-injury levels to account for potential symptom exacerbation due to the TBI. The RPQ is the most commonly used clinical measure for mild TBI research because it is simple and reflects psychosocial function. The RPQ is intended to measure the presence and severity of 16 of the most commonly reported post-concussion symptoms found in the literature. The RPQ scale includes 16 common post-concussion symptom items whose responses range from 0= Not experienced at to 4= A severe problem. Total range is 0 to 64. The scores were derived by totaling the corresponding question scores for each domain and it's change from baseline.
Time frame: Baseline to week 13, Months 6 and 12
Population: 1 subject in HBO2 missed the 6 month visit and 2 subjects missed the 12 month visit. 1 subject in the sham missed the week 13 visit and, 1 subject missed the month 6 visit and 3 subjects withdrew by month 12
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HBO2 at 1.5 Atomspheres Absolute (ATA) | Presence of Post Concussion Symptoms Following Traumatic Brain Injury Using The Rivermead Post-Concussion Symptom Questionnaire (RPQ) - Change From Baseline (ITT Population) | Week 13 change score | -0.7 RPQ scores | Standard Deviation 14.6 |
| HBO2 at 1.5 Atomspheres Absolute (ATA) | Presence of Post Concussion Symptoms Following Traumatic Brain Injury Using The Rivermead Post-Concussion Symptom Questionnaire (RPQ) - Change From Baseline (ITT Population) | Month 6 change score | -4.3 RPQ scores | Standard Deviation 14 |
| HBO2 at 1.5 Atomspheres Absolute (ATA) | Presence of Post Concussion Symptoms Following Traumatic Brain Injury Using The Rivermead Post-Concussion Symptom Questionnaire (RPQ) - Change From Baseline (ITT Population) | Month 12 change score | 5.7 RPQ scores | Standard Deviation 14.7 |
| Sham Control (1.2 Atomspheres) | Presence of Post Concussion Symptoms Following Traumatic Brain Injury Using The Rivermead Post-Concussion Symptom Questionnaire (RPQ) - Change From Baseline (ITT Population) | Month 6 change score | 2.6 RPQ scores | Standard Deviation 11.6 |
| Sham Control (1.2 Atomspheres) | Presence of Post Concussion Symptoms Following Traumatic Brain Injury Using The Rivermead Post-Concussion Symptom Questionnaire (RPQ) - Change From Baseline (ITT Population) | Week 13 change score | 5.8 RPQ scores | Standard Deviation 12.4 |
| Sham Control (1.2 Atomspheres) | Presence of Post Concussion Symptoms Following Traumatic Brain Injury Using The Rivermead Post-Concussion Symptom Questionnaire (RPQ) - Change From Baseline (ITT Population) | Month 12 change score | 5.5 RPQ scores | Standard Deviation 12.4 |
Secondary
Presence of Post Concussion Symptoms Following Traumatic Brain Injury Using The Rivermead Post-Concussion Symptom Questionnaire (RPQ) - Change From Baseline (Per Protocol (PP) Population)
RPQ was created to measure the severity of post-concussion symptoms following traumatic brain injury. Scale compares any current symptoms to pre-injury levels to account for potential symptom exacerbation due to the TBI. The RPQ is the most commonly used clinical measure for mild TBI research because it is simple and reflects psychosocial function. The RPQ is intended to measure the presence and severity of 16 of the most commonly reported post-concussion symptoms found in the literature. The RPQ scale includes 16 common post-concussion symptom items whose responses range from 0= Not experienced at to 4= A severe problem. Total range is 0 to 64. For the RPQ total scales, the scores were derived by totaling the corresponding question scores for each domain and change from baseline.
Time frame: Baseline to month 24 and month 36
Population: PP was defined as subs who completed 20 chamber sessions and week13 f/u. PP was also restricted to subs who didn't report illicit drug use following randomization. 67 subs satisfied the PP, 35/36 HBO2 and 32/35 sham. 4 were excluded from the PP population, 3 excluded because they completed \<20 sessions,1 because of illicit drug use during study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HBO2 at 1.5 Atomspheres Absolute (ATA) | Presence of Post Concussion Symptoms Following Traumatic Brain Injury Using The Rivermead Post-Concussion Symptom Questionnaire (RPQ) - Change From Baseline (Per Protocol (PP) Population) | Baseline to month 24 | 1.2 RPQ scores | Standard Deviation 18.5 |
| HBO2 at 1.5 Atomspheres Absolute (ATA) | Presence of Post Concussion Symptoms Following Traumatic Brain Injury Using The Rivermead Post-Concussion Symptom Questionnaire (RPQ) - Change From Baseline (Per Protocol (PP) Population) | Baseline to month 36 | 1.4 RPQ scores | Standard Deviation 9 |
| Sham Control (1.2 Atomspheres) | Presence of Post Concussion Symptoms Following Traumatic Brain Injury Using The Rivermead Post-Concussion Symptom Questionnaire (RPQ) - Change From Baseline (Per Protocol (PP) Population) | Baseline to month 36 | 4.6 RPQ scores | Standard Deviation 19.6 |
| Sham Control (1.2 Atomspheres) | Presence of Post Concussion Symptoms Following Traumatic Brain Injury Using The Rivermead Post-Concussion Symptom Questionnaire (RPQ) - Change From Baseline (Per Protocol (PP) Population) | Baseline to month 24 | 2.9 RPQ scores | Standard Deviation 11.9 |
Secondary
Presence of Post Concussion Symptoms Following Traumatic Brain Injury Using The Rivermead Post-Concussion Symptom Questionnaire (RPQ) - Change From Baseline (Per Protocol (PP) Population)
RPQ was created to measure the severity of post-concussion symptoms following traumatic brain injury. Scale compares any current symptoms to pre-injury levels to account for potential symptom exacerbation due to the TBI. The RPQ is the most commonly used clinical measure for mild TBI research because it is simple and reflects psychosocial function. The RPQ is intended to measure the presence and severity of 16 of the most commonly reported post-concussion symptoms found in the literature. The RPQ scale includes 16 common post-concussion symptom items whose responses range from 0= Not experienced at to 4= A severe problem. Total range is 0 to 64. RPQ-3 ranges from 0-12 and access a subset of symptoms. For the RPQ total scales, the scores were derived by totaling the corresponding question scores for each domain and change from baseline.
Time frame: Baseline to week 13, Months 6 and 12
Population: PP was defined as subs who completed 20 chamber sessions and week13 f/u. PP was also restricted to subs who didn't report illicit drug use following randomization. 67 subs satisfied the PP, 35/36 HBO2 and 32/35 sham. 4 were excluded from the PP population, 3 excluded because they completed \<20 sessions,1 because of illicit drug use during study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HBO2 at 1.5 Atomspheres Absolute (ATA) | Presence of Post Concussion Symptoms Following Traumatic Brain Injury Using The Rivermead Post-Concussion Symptom Questionnaire (RPQ) - Change From Baseline (Per Protocol (PP) Population) | Month 12 change score | 5.8 RPQ scores | Standard Deviation 14.9 |
| HBO2 at 1.5 Atomspheres Absolute (ATA) | Presence of Post Concussion Symptoms Following Traumatic Brain Injury Using The Rivermead Post-Concussion Symptom Questionnaire (RPQ) - Change From Baseline (Per Protocol (PP) Population) | Week 13 change score | -1.0 RPQ scores | Standard Deviation 14.7 |
| HBO2 at 1.5 Atomspheres Absolute (ATA) | Presence of Post Concussion Symptoms Following Traumatic Brain Injury Using The Rivermead Post-Concussion Symptom Questionnaire (RPQ) - Change From Baseline (Per Protocol (PP) Population) | Month 6 change score | -4.3 RPQ scores | Standard Deviation 14 |
| Sham Control (1.2 Atomspheres) | Presence of Post Concussion Symptoms Following Traumatic Brain Injury Using The Rivermead Post-Concussion Symptom Questionnaire (RPQ) - Change From Baseline (Per Protocol (PP) Population) | Month 6 change score | 3.2 RPQ scores | Standard Deviation 11.3 |
| Sham Control (1.2 Atomspheres) | Presence of Post Concussion Symptoms Following Traumatic Brain Injury Using The Rivermead Post-Concussion Symptom Questionnaire (RPQ) - Change From Baseline (Per Protocol (PP) Population) | Week 13 change score | 6.1 RPQ scores | Standard Deviation 12.6 |
| Sham Control (1.2 Atomspheres) | Presence of Post Concussion Symptoms Following Traumatic Brain Injury Using The Rivermead Post-Concussion Symptom Questionnaire (RPQ) - Change From Baseline (Per Protocol (PP) Population) | Month 12 change score | 5.5 RPQ scores | Standard Deviation 12.6 |
Secondary
Presence of Post Concussion Symptoms Following Traumatic Brain Injury Using The Rivermead Post-Concussion Symptom Questionnaire (RPQ, RPQ3 and RPQ13) - Baseline (ITT Population)
RPQ/RPQ-3 was created to measure the severity of post-concussion symptoms following traumatic brain injury. Scale compares any current symptoms to pre-injury levels to account for potential symptom exacerbation due to the TBI. The RPQ is the most commonly used clinical measure for mild TBI research because it is simple and reflects psychosocial function. The RPQ is intended to measure the presence and severity of 16 of the most commonly reported post-concussion symptoms found in the literature. The RPQ scale includes 16 common post-concussion symptom items whose responses range from 0= Not experienced at to 4= A severe problem. Total range is 0 to 64. RPQ-3 ranges from 0-12 and access a subset of symptoms. RPQ-13 ranges from 0-52 and access's 13 remaining symptoms. Analyses of the RPQ-3 and RPQ-13 domain scores are presented separately. For each of the RPQ-3, RPQ-13, and RPQ total scales, the scores were derived by totaling the corresponding question scores for each domain.
Time frame: Baseline
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HBO2 at 1.5 Atomspheres Absolute (ATA) | Presence of Post Concussion Symptoms Following Traumatic Brain Injury Using The Rivermead Post-Concussion Symptom Questionnaire (RPQ, RPQ3 and RPQ13) - Baseline (ITT Population) | RPQ Total Score | 34.8 RPQ scores | Standard Deviation 13.1 |
| HBO2 at 1.5 Atomspheres Absolute (ATA) | Presence of Post Concussion Symptoms Following Traumatic Brain Injury Using The Rivermead Post-Concussion Symptom Questionnaire (RPQ, RPQ3 and RPQ13) - Baseline (ITT Population) | RPQ-3 Score | 5.8 RPQ scores | Standard Deviation 2.9 |
| HBO2 at 1.5 Atomspheres Absolute (ATA) | Presence of Post Concussion Symptoms Following Traumatic Brain Injury Using The Rivermead Post-Concussion Symptom Questionnaire (RPQ, RPQ3 and RPQ13) - Baseline (ITT Population) | RPQ-13 Score | 29.0 RPQ scores | Standard Deviation 11 |
| Sham Control (1.2 Atomspheres) | Presence of Post Concussion Symptoms Following Traumatic Brain Injury Using The Rivermead Post-Concussion Symptom Questionnaire (RPQ, RPQ3 and RPQ13) - Baseline (ITT Population) | RPQ-3 Score | 4.5 RPQ scores | Standard Deviation 2.6 |
| Sham Control (1.2 Atomspheres) | Presence of Post Concussion Symptoms Following Traumatic Brain Injury Using The Rivermead Post-Concussion Symptom Questionnaire (RPQ, RPQ3 and RPQ13) - Baseline (ITT Population) | RPQ Total Score | 28.2 RPQ scores | Standard Deviation 13.5 |
| Sham Control (1.2 Atomspheres) | Presence of Post Concussion Symptoms Following Traumatic Brain Injury Using The Rivermead Post-Concussion Symptom Questionnaire (RPQ, RPQ3 and RPQ13) - Baseline (ITT Population) | RPQ-13 Score | 23.7 RPQ scores | Standard Deviation 11.4 |
Secondary
Presence of Post Concussion Symptoms Following Traumatic Brain Injury Using The Rivermead Post-Concussion Symptom Questionnaire (RPQ, RPQ3 and RPQ13) - Baseline (Per Protocol (PP) Population)
RPQ/RPQ-3 was created to measure the severity of post-concussion symptoms following traumatic brain injury. Scale compares any current symptoms to pre-injury levels to account for potential symptom exacerbation due to the TBI. The RPQ is the most commonly used clinical measure for mild TBI research because it is simple and reflects psychosocial function. The RPQ is intended to measure the presence and severity of 16 of the most commonly reported post-concussion symptoms found in the literature. The RPQ scale includes 16 common post-concussion symptom items whose responses range from 0= Not experienced at to 4= A severe problem. Total range is 0 to 64. RPQ-3 ranges from 0-12 and access a subset of symptoms. RPQ-13 ranges from 0-52 and access's 13 remaining symptoms. Analyses of the RPQ-3 and RPQ-13 domain scores are presented separately. For each of the RPQ-3, RPQ-13, and RPQ total scales, the scores were derived by totaling the corresponding question scores for each domain.
Time frame: Baseline
Population: PP was defined as subs who completed 20 chamber sessions and week13 f/u. PP was also restricted to subs who didn't report illicit drug use following randomization. 67 subs satisfied the PP, 35/36 HBO2 and 32/35 sham. 4 were excluded from the PP population, 3 excluded because they completed \<20 sessions,1 because of illicit drug use during study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HBO2 at 1.5 Atomspheres Absolute (ATA) | Presence of Post Concussion Symptoms Following Traumatic Brain Injury Using The Rivermead Post-Concussion Symptom Questionnaire (RPQ, RPQ3 and RPQ13) - Baseline (Per Protocol (PP) Population) | RPQ Total Score | 34.7 RPQ scores | Standard Deviation 13.3 |
| HBO2 at 1.5 Atomspheres Absolute (ATA) | Presence of Post Concussion Symptoms Following Traumatic Brain Injury Using The Rivermead Post-Concussion Symptom Questionnaire (RPQ, RPQ3 and RPQ13) - Baseline (Per Protocol (PP) Population) | RPQ-3 Score | 5.8 RPQ scores | Standard Deviation 2.9 |
| HBO2 at 1.5 Atomspheres Absolute (ATA) | Presence of Post Concussion Symptoms Following Traumatic Brain Injury Using The Rivermead Post-Concussion Symptom Questionnaire (RPQ, RPQ3 and RPQ13) - Baseline (Per Protocol (PP) Population) | RPQ-13 Score | 28.9 RPQ scores | Standard Deviation 11.1 |
| Sham Control (1.2 Atomspheres) | Presence of Post Concussion Symptoms Following Traumatic Brain Injury Using The Rivermead Post-Concussion Symptom Questionnaire (RPQ, RPQ3 and RPQ13) - Baseline (Per Protocol (PP) Population) | RPQ Total Score | 27.3 RPQ scores | Standard Deviation 12.9 |
| Sham Control (1.2 Atomspheres) | Presence of Post Concussion Symptoms Following Traumatic Brain Injury Using The Rivermead Post-Concussion Symptom Questionnaire (RPQ, RPQ3 and RPQ13) - Baseline (Per Protocol (PP) Population) | RPQ-3 Score | 4.5 RPQ scores | Standard Deviation 2.5 |
| Sham Control (1.2 Atomspheres) | Presence of Post Concussion Symptoms Following Traumatic Brain Injury Using The Rivermead Post-Concussion Symptom Questionnaire (RPQ, RPQ3 and RPQ13) - Baseline (Per Protocol (PP) Population) | RPQ-13 Score | 22.8 RPQ scores | Standard Deviation 11 |