Traumatic Brain Injury, PTSD - Post Traumatic Stress Disorder, Anxiety, Depression, Post Concussion Symptoms
Conditions
Keywords
First responders, Traumatic Brain Injury (TBI), Post Concussion Symptoms, Hyperbaric Oxygen Therapy (HBOT), Cognitive Functioning, Post-traumatic stress disorder (PTSD), Depression, Anxiety, Quality of Life
Brief summary
The goal of this study is to examine changes in cognitive functioning and post-concussive symptoms following hyperbaric oxygen therapy (HBOT) in current and former first responders with a history of traumatic brain injury. The main questions it aims to answer are: 1. Do cognitive functioning and post-concussive symptoms change after 40 HBOT sessions? 2. Do symptoms of PTSD, depression, and anxiety, or quality of life, change after treatment? Approximately 54 participants will: * Complete medical and behavioral health screening. * Complete cognitive tests and questionnaires before and after treatment. * Receive 40 HBOT sessions at 2.0 atmospheres absolute (ATA), twice daily with at least four hours between sessions. All participants will receive HBOT. There is no comparison group, so the study cannot determine whether HBOT caused any observed changes.
Detailed description
This prospective, single-arm study will examine changes in cognitive functioning and post-concussive symptoms following hyperbaric oxygen therapy (HBOT) in approximately 54 current or former first responders with a history of traumatic brain injury (TBI). Secondary outcomes include symptoms of post-traumatic stress disorder (PTSD), depression, and anxiety, as well as quality of life. After providing informed consent, participants will undergo medical and behavioral health screening to determine eligibility for HBOT. Eligible participants will complete baseline cognitive testing and questionnaires measuring post-concussive symptoms, psychological symptoms, and quality of life. These assessments will be repeated after treatment. Participants will receive 40 HBOT sessions in a multiplace chamber at 2.0 atmospheres absolute (ATA). Each session will include two 30-minute periods of breathing 100% oxygen separated by a 5-minute air break. Sessions will take place twice daily, Monday through Friday, with at least four hours between sessions. A physician will prescribe and oversee treatment, and trained hyperbaric personnel will operate the chamber and monitor participants. Changes between baseline and post-treatment assessments will be analyzed within participants. The study will also explore whether demographic or clinical characteristics are associated with the magnitude of change. All participants will receive HBOT; there is no randomized or untreated comparison group. As a result, the study can describe changes observed following treatment but cannot establish that HBOT caused those changes.
Interventions
Participants in this arm will receive 40 hyperbaric oxygen therapy (HBOT) sessions at 2.0 atmospheres absolute (ATA). Sessions will occur twice daily, Monday through Friday, with at least four hours between sessions. Cognitive functioning, post-concussive symptoms, psychological symptoms, and quality of life will be assessed before and after treatment.
Sponsors
Summit Hyperbarics and Wellness
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Hyperbaric Oxygen Therapy (HBOT): Participants will receive 40 sessions in a multiplace hyperbaric chamber at 2.0 atmospheres absolute (ATA). Each session includes two 30-minute periods of breathing 100% oxygen, separated by a 5-minute air break. Sessions will occur twice daily, Monday through Friday, with at least four hours between sessions.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Adults aged 18 to 75 years. 2. Current or former first responder. 3. Clinically diagnosed with a traumatic brain injury (TBI) and current or persistent post-concussive syndrome, as determined by a qualified health care professional. 4. Participants with comorbid PTSD, depression, or anxiety may be enrolled if all other eligibility criteria are met; these symptoms will be assessed as secondary/exploratory outcomes. 5. Ability to provide informed consent, including the ability to read, understand, and voluntarily sign the informed consent document. 6. Completion of baseline cognitive and psychological assessment measures as part of study enrollment procedures. 7. Presence of clinically significant symptoms resulting in functional impairment in occupational, social, or other key areas of functioning, as determined by clinical evaluation. 8. Sexually active female participants of childbearing potential and sexually active male participants with female partners of childbearing potential must agree to use an acceptable method of contraception for the duration of the study and for 30 days following the final HBOT session. 9. Stable regimen of psychoactive medications (if applicable), including antidepressants, anxiolytics, antipsychotics, stimulants, and mood stabilizers, for a clinically appropriate stabilization period prior to enrollment, as determined by the study physician.
Exclusion criteria
1. Untreated pneumothorax 2. History of spontaneous pneumothorax 3. Severe sinus infection 4. Upper respiratory infection 5. Asymptomatic pulmonary lesions on chest x-ray 6. Uncontrollable high fever (greater than 39C) 7. History of chest or ear surgery 8. Congenital spherocytosis 9. Any anemia or blood disorder 10. Any convulsive disorder 11. History of optic neuritis or sudden blindness 12. Middle ear infection 13. Diabetes mellitus (insulin therapy) 14. The participant is pregnant or lactating 15. Nicotine use/substance use/addiction 16. Acute Hypoglycemia 17. Diagnosed Chronic Obstructive Pulmonary Disease (COPD) and Emphysema 18. Presenting with symptoms of cough, congestion, vomiting, diarrhea, or open wounds. 19. Active malignancy 20. Current manic, delusional, or psychotic episodes 21. Serious/current suicidal ideations 22. Severe or unstable physical disorders or major cognitive deficits 23. Inability to attend scheduled clinic visits or comply with study protocols. 24. Treated with HBOT for any reason prior to study enrollment. 25. Non-English speakers 26. History of retinal repair, including laser photocoagulation or retinal detachment surgery. 27. History of middle ear surgery, including tympanoplasty, mastoidectomy, or pressure equalization tube placement. 28. Age greater than 75 years. 29. Use of any of the following medications during the study period: Anti-metabolites (e.g., methotrexate, azathioprine); Chemotherapuetic agents (e.g., cyclophosphamide, cisplatin); Mafenide acetate e.g., Sulfamylon); Disulfiram (e.g, Antabuse); Peripheral vasodilators known to interact with oxygen exposure (e.g., nitroglycerin); and Antibacterial drugs with known HBOT interaction risks.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in NeuroTrax Global Cognitive Score | Baseline and after completion of 40 HBOT sessions (approximately 4 weeks). | Change in Global Cognitive Score from baseline to completion of 40 HBOT sessions. |
| Change in Rivermead Post-Concussion Symptoms Questionnaire (RPQ) score | Baseline and after completion of 40 HBOT sessions (approximately 4 weeks). | Change in post-concussive symptom score from baseline to completion of 40 HBOT sessions. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in PTSD Checklist for DSM-5 (PCL-5) score | Baseline and after completion of 40 HBOT sessions (approximately 4 weeks). | Change in PTSD symptom score from baseline to completion of 40 HBOT sessions. |
| Change in Patient Health Questionnaire-9 (PHQ-9) score | Baseline and after completion of 40 HBOT sessions (approximately 4 weeks). | Change in depression symptom score from baseline to completion of 40 HBOT sessions. |
| Change in Generalized Anxiety Disorder-7 (GAD-7) score | Baseline and after completion of 40 HBOT sessions (approximately 4 weeks). | Change in anxiety symptom score from baseline to completion of 40 HBOT sessions. |
| Change in World Health Organization Quality of Life-BREF (WHOQOL-BREF) domain scores | Baseline and after completion of 40 HBOT sessions (approximately 4 weeks). | Change in quality-of-life scores from baseline to completion of 40 HBOT sessions. |
Countries
United States
Contacts
CONTACTTroy Nickel, Ph.D.
PRINCIPAL_INVESTIGATORSteve Wyman, MD
Summit Hyperbarics and Wellness
Outcome results
None listed