Traumatic Brain Injury, Post-Concussive Symptoms, Post-Traumatic Stress Disorder
Conditions
Keywords
Hyperbaric Oxygen Therapy, Treatment Durability, Cognitive Function, Mental Health, Quality of Life, Veterans, Traumatic Brain Injury, Persistent Post-Concussive Symptoms (PCS)
Brief summary
This study is designed to better understand the long-term effects of hyperbaric oxygen therapy (HBOT). Our goal is to determine whether improvements after treatment are maintained over time and whether additional benefits appear months after treatment has ended. We will evaluate changes in cognitive function, mental health, and daily functioning to help strengthen the scientific evidence supporting the use of HBOT and guide future treatment recommendations.
Detailed description
This study is designed to evaluate the long-term effects of hyperbaric oxygen therapy (HBOT) following the completion of treatment. While previous research has demonstrated promising improvements, less is known about whether these benefits are sustained over time or whether additional improvements continue to emerge after treatment has ended. The primary objective of this study is to evaluate the persistence of therapeutic effects following the completion of Hyperbaric Oxygen Therapy (HBOT) in veterans, with a focus on cognitive function and symptom reduction related to PTSD, depression, and anxiety. Follow-up assessments will be conducted 12 weeks post-treatment to determine the durability of these outcomes. The second objective is to evaluate potential delayed (latency) effects of HBOT on cognitive performance, psychological symptoms (e.g., PTSD, depression, anxiety), and functional status. The findings of this study will help identify the persistence of treatment effects, characterize the timeline of durability, and strengthen the scientific evidence supporting the long-term use of HBOT for individuals with traumatic brain injury, persistent post-concussive symptoms, and post-traumatic stress disorder.
Interventions
Hyperbaric Oxygen Therapy (HBOT): Participants will receive 100% medical oxygen (USP) administered under hyperbaric conditions at 2.0 atmospheres absolute (ATA) for 60 minutes with a scheduled air break over 40 treatment sessions.
Sponsors
Summit Hyperbarics and Wellness
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
This study utilizes a quasi-longitudinal design incorporating follow-up assessments to examine the sustained effects of Hyperbaric Oxygen Therapy (HBOT) on cognitive function, mental health, and quality of life in a cohort of veterans. Follow-up evaluations will employ validated cognitive and psychometric instruments to assess the durability of HBOT's therapeutic effects post-intervention. The post-treatment assessment is scheduled 12 weeks after each subject's final HBOT session.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. At least 18 years of age. 2. Veteran status 3. Clinically diagnosed with a mTBI, PCS, PTSD, Anxiety, or Depression disorder. 4. Successfully completed the parent Hyperbaric Oxygen Therapy (HBOT) intervention, consisting of the full study treatment protocol (40 HBOT sessions). 5. Willing and able to read, understand, and provide written informed consent for participation in the 12-week follow-up study. Additionally, the Participant has clear consciousness and the ability to express self-feelings independently. 6. Completed cognitive and psychological measurements. 7. Clinical diagnoses cause significant impairment in social or occupational functioning or some other functional capacity. 8. Stability on any current psychoactive medications (antidepressants, anti-anxiety medications, antipsychotics, stimulants, and mood stabilizers).
Exclusion criteria
1. Acute medical illness or infection 2. Severe or unstable physical disorders or major cognitive deficits 3. Current manic, psychotic episodes, or serious suicidal ideations 4. Non-English speakers 5. Inability to attend scheduled follow-up visits 6. Significant life events, new neurological injury, or new psychiatric diagnosis or hospitalization occurring after completion of the HBOT intervention that, in the opinion of the investigator, could confound cognitive, psychological, or quality-of-life outcomes. 7. Participation in another interventional clinical study or receipt of a therapeutic intervention following completion of HBOT that could influence cognitive, psychological, or quality-of-life outcomes.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| NeuroTrax | Baseline (post-HBOT completion) and 12 weeks after the final HBOT session | A computerized cognitive test to measure various cognitive functions, including memory, executive functioning, visual-spatial perception, verbal function, attention, information processing speed, and motor skills. |
| PTSD Checklist for DSM-5 (PCL-5) | Baseline (post-HBOT completion) and 12 weeks after the final HBOT session | Self-report questionnaire to assess symptoms of PTSD |
| Patient Health Questionnaire-9 (PHQ-9) | Baseline (post-HBOT completion) and 12 weeks after the final HBOT session | Self-report questionnaire to assess depression severity |
| Generalized Anxiety Disorder 7-item scale (GAD-7) | Baseline (post-HBOT completion) and 12 weeks after the final HBOT session | Self-report questionnaire to measure anxiety severity |
| World Health Organization Quality of Life (WHOQOL-BREF) | Baseline (post-HBOT completion) and 12 weeks after the final HBOT session | Self-report questionnaire to rate a person's perception of his/her position in their life in the context of physical, psychological, level of independence, social relationships, and environment facets |
Countries
United States
Contacts
CONTACTTroy Nickel, PhD
Outcome results
None listed