Post-Concussion SyndromeNCT05643482
Hyperbaric Oxygen Therapy for Post-Concussion Syndrome
A study testing Hyperbaric Oxygen Treatment in people with Post-Concussion Syndrome, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial summary
The purpose of this study is to decrease symptom burden, improve cognitive function, and improve quality of life outcomes in subjects with mild TBI and persisting post-concussion syndrome using Hyperbaric Oxygen Treatment compared to a sham intervention. Specific Aims: 1. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Post-Concussion Syndrome
- What is being tested?
- Hyperbaric Oxygen Treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2023to 12 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Must have been evaluated within 3 weeks of injury and given a diagnosis of concussion by a medical professional
- Must be experiencing persistent symptoms 3-12 months after injury as defined as having at least symptoms that are moderate to severe (score 3-4) OR at least a total score of 10 with at least 1 symptom rated moderate to severe (3-4) on the Rivermead Post-Concussion Questionnaire (RPQ).
Who cannot join
- Clinically significant cardiac, neurological, psychological/psychiatric, or respiratory impairment in the opinion of the investigators, including but not limited to:
- Pulmonary:
- COPD with CO2 retention; previous/current imaging showing hyperinflation/air trapping/bullous disease/blebs
- Current pneumothorax or previous spontaneous pneumothorax
- Cardiac:
- Uncontrolled HTN (systolic >180 or diastolic >100)
Show all 46Show fewer
- Known Ejection fraction < 35%
- Pacemaker / ICD in place (not approved for chamber use)
- Hematological/Oncological:
- Current chemotherapeutic drug use, and past history of bleomycin use.
- Hereditary Spherocytosis
- Sickle cell anemia
- Neurological and Psychological:
- Implanted nerve stimulators
- Uncontrolled seizure disorder
- Drug or alcohol abuse/dependence
- Current treatment for alcohol cessation with disulfiram
- Claustrophobia
- Head and Neck:
- Inability to equilibrate the pressure of middle ears and sinuses
- Current or previous retinal detachment
- Retinal or vitreous surgery within the past 3 months
- Miscellaneous:
- Current fever or active infection
- Implanted devices not on the approved list for use with HBOT
- Women who are pregnant. Women with childbearing potential are required to use effective birth control if not surgically sterile or postmenopausal for >2 years.
- Undergoing vestibular or other therapy during the intervention
- Planning a change in medication during the intervention
- Relative exclusion criteria: Diagnosis of the conditions listed below will require approval of the hyperbaric medicine physician for enrollment into the study.
- Asthma
- Optic neuritis
- Otosclerosis surgery
- Thoracic surgery
- Chronic sinusitis
- Medications: Individuals with recent (within the past six months) or concurrent use of these medications must be approved by the hyperbaric medicine physician.
- Antabuse - Predisposes to oxygen toxicity
- Antiseizure medications - Potential participants must have levels of their seizure medications checked within a week of their initial screening visit because low levels can predispose to oxygen toxicity. Laboratory testing must be completed by their outside treating physicians to provide to the research staff for review; the study will not obtain labs for monitoring medication levels as part of the inclusion/exclusion criteria
- Meclizine - Predisposes to oxygen toxicity
- Bleomycin - May cause pulmonary fibrosis that can lead to air embolism or pneumothorax in the patient receiving hyperbaric oxygen treatment.
- Certain ointments/creams that cannot be removed - These may be allowed if covered with cotton dressings.
- Narcotics - Can lead to cessation of the hypoxic respiratory drive.
- Nitroprusside - HBOT vasoconstrictive effect interacts with nitroprusside's vasodilator effect, making intensive monitoring mandatory.
- Penicillin - Predisposes to oxygen toxicity
- Promethazine (Phenergan) - Predisposes to oxygen toxicity.
- Corticosteroids - Decreases the threshold for oxygen toxicity.
- Sulfamylon - Promotes CO2 buildup causing peripheral vasodilatation. When coupled with vasoconstriction, results are worse than with using either agent alone. Use silver sulfadiazine instead for wound care.
Trial locations and contacts
1 site in 1 country.
United States1 site
Institute for Exercise and Environmental Medicine/University of Texas Southwestern Medical Center
Dallas, Texas, 75231
About this study
Official title: Hyperbaric Oxygen Therapy for Post-Concussion Syndrome: A Double-Blind, Randomized, Placebo-Controlled Pilot Study
The purpose of this study is to decrease symptom burden, improve cognitive function, and improve quality of life outcomes in subjects with mild TBI and persisting post-concussion syndrome using Hyperbaric Oxygen Treatment compared to a sham intervention.
Specific Aims:
- Evaluate the efficacy of hyperbaric oxygen treatment to improve outcomes for adults with persisting post-concussion syndrome. Specifically, the investigators hypothesize that a prescribed course of hyperbaric oxygen treatments (HBOT) will improve outcomes and quality of life in adults with persisting symptoms >3 months after injury.
- Decrease symptom burden as measured by the Rivermead Post-Concussion Symptoms Questionnaire (RPQ).
- Improve cognitive function as measured by the National Institutes of Health (NIH) Toolbox Cognition Battery.
- Improve quality of life as measured by the 36-Item Short Form Survey (SF-36).
- Assess the safety and tolerability of hyperbaric oxygen treatments and compliance with treatment in adults with persisting post-concussion syndrome.
- Conditions
- Post-Concussion Syndrome
- Being tested
- Hyperbaric Oxygen Treatment, Placebo gas
- Medical subject headings
- Post-Concussion Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyperbaric Oxygen TreatmentDevice
Pressurization at 2.0 ATA with 100% oxygen
Placebo gasOther
Pressurization at 2.0 ATA with 10.5% oxygen to mimic normal air
| Study group | Role | What they receive |
|---|---|---|
| HBOT Arm | Experimental | Pressurized at 2.0 atmospheres absolute of pressure (ATA) Breathe 100% oxygen 90 minute session, 5 days per week, for 20 sessions Receives: Device: Hyperbaric Oxygen Treatment |
| Control Arm | Sham comparator | Placebo Gas Pressurized at 2.0 ATA Breathe placebo gas system of 10.5% oxygen and 89.5% nitrogen to mimic the partial pressure of oxygen breathed in regular air at sea level pressure 90 minute session, 5 days per week, for 20 sessions Receives: Other: Placebo gas |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in symptom burden as measured by the Rivermead Post-Concussion Symptoms Questionnaire-3 (RPQ-3)
Change in symptom burden is measured by the Rivermead Post-Concussion Symptoms Questionnaire-3 (RPQ-3) which is a 16 item questionnaire of common cognitive, behavioral, and physical symptoms experienced following a mTBI. The RPQ is rated on a 0-4 scale with scores ranging from 0-64. Higher levels of endorsement indicate more severe symptoms. The RPQ-3 is the total score of the first three items of the RPQ and includes "headaches," "feelings of dizziness," and "nausea and/or vomiting."
Measured: Baseline, immediately after treatment
Change in symptom burden as measured by the Rivermead Post-Concussion Symptoms Questionnaire-3 (RPQ-3)
Change in symptom burden is measured by the Rivermead Post-Concussion Symptoms Questionnaire-3 (RPQ-3) which is a 16 item questionnaire of common cognitive, behavioral, and physical symptoms experienced following a mTBI. The RPQ is rated on a 0-4 scale with scores ranging from 0-64. Higher levels of endorsement indicate more severe symptoms. The RPQ-3 is the total score of the first three items of the RPQ and includes "headaches," "feelings of dizziness," and "nausea and/or vomiting."
Measured: Baseline, 1 month after treatment
Secondary outcomes (19)
Change in symptom burden as measured by the Rivermead Post-Concussion Symptoms Questionnaire-13 (RPQ-13)
Change in symptom burden is measured by the Rivermead Post-Concussion Symptoms Questionnaire (RPQ) which is a 16 item questionnaire of common cognitive, behavioral, and physical symptoms experienced following a mTBI. The RPQ is rated on a 0-4 scale with scores ranging from 0-64. Higher levels of endorsement indicate more severe symptoms. The RPQ-3 is the total score of the first three items of the RPQ and includes "headaches," "feelings of dizziness," and "nausea and/or vomiting." The RPQ-13 is the total score of the remaining 13 items on the RPQ scale.
Measured: Baseline, immediately after last treatment
Change in symptom burden as measured by the Rivermead Post-Concussion Symptoms Questionnaire-13 (RPQ-13)
Change in symptom burden is measured by the Rivermead Post-Concussion Symptoms Questionnaire (RPQ) which is a 16 item questionnaire of common cognitive, behavioral, and physical symptoms experienced following a mTBI. The RPQ is rated on a 0-4 scale with scores ranging from 0-64. Higher levels of endorsement indicate more severe symptoms. The RPQ-3 is the total score of the first three items of the RPQ and includes "headaches," "feelings of dizziness," and "nausea and/or vomiting." The RPQ-13 is the total score of the remaining 13 items on the RPQ scale.
Measured: Baseline, 1 month after treatment
Change in quality of life as measured by the Short Form Survey (SF-36)
Change in quality of life is measured by the Short Form Survey (SF-36) which consists of 36 items and measures quality of life via eight different domains including vitality, physical functioning, social functioning, emotional role, physical role, general health, social functioning, and mental health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The higher scores indicating better levels of function and/or better health. A positive change from Baseline indicates improvement.
Measured: Baseline, immediately after treatment
Change in quality of life as measured by the Short Form Survey (SF-36)
Change in quality of life is measured by the Short Form Survey (SF-36) which consists of 36 items and measures quality of life via eight different domains including vitality, physical functioning, social functioning, emotional role, physical role, general health, social functioning, and mental health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The higher scores indicating better levels of function and/or better health. A positive change from Baseline indicates improvement.
Measured: Baseline, 1 month
Global Impression of Change (GIC)
The Global Impression of Change scale is a seven-point scale in which participants are asked to rate how much the treatment has changed their activity limitations, symptoms, emotions, and overall quality of life. Possible scores range from -3 (very much worse) to +3 (very much better) with 0 being no change.
Measured: Baseline, after 5 treatment sessions (approximately 1 week after starting treatment)
Global Impression of Change (GIC)
The Global Impression of Change scale is a seven-point scale in which participants are asked to rate how much the treatment has changed their activity limitations, symptoms, emotions, and overall quality of life. Possible scores range from -3 (very much worse) to +3 (very much better) with 0 being no change.
Measured: Baseline, after 10 treatment sessions (approximately 2 weeks after starting treatment)
Global Impression of Change (GIC)
The Global Impression of Change scale is a seven-point scale in which participants are asked to rate how much the treatment has changed their activity limitations, symptoms, emotions, and overall quality of life. Possible scores range from -3 (very much worse) to +3 (very much better) with 0 being no change.
Measured: Baseline, after 15 treatment sessions (approximately 3 weeks after starting treatment)
Global Impression of Change (GIC)
The Global Impression of Change scale is a seven-point scale in which participants are asked to rate how much the treatment has changed their activity limitations, symptoms, emotions, and overall quality of life. Possible scores range from -3 (very much worse) to +3 (very much better) with 0 being no change.
Measured: Baseline, after 20 treatment sessions (approximately 3 weeks after starting treatment)
Global Impression of Change (GIC)
The Global Impression of Change scale is a seven-point scale in which participants are asked to rate how much the treatment has changed their activity limitations, symptoms, emotions, and overall quality of life. Possible scores range from -3 (very much worse) to +3 (very much better) with 0 being no change.
Measured: Baseline, 1 month post-treatment
Percentage of participant feeling of back to normal, pre-injury self at baseline as assessed based on patient rating
Percentage of participant feeling of back to normal, pre-injury self at baseline is assessed based on patient rating. Participants will be asked to rate what percent they feel back to their normal, pre-injury self at baseline
Measured: Baseline
Percent change in participant feeling of back to normal, pre-injury self as assessed based on patient rating
Percent change in participant feeling of back to normal, pre-injury self is assessed based on patient rating. Participants will be asked to rate what percent they feel back to their normal, pre-injury self at baseline
Measured: Baseline, after 5 treatment sessions (approximately 1 week after starting treatment)
Percent change in participant feeling of back to normal, pre-injury self as assessed based on patient rating.
Percent change in participant feeling of back to normal, pre-injury self is assessed based on patient rating. Participants will be asked to rate what percent they feel back to their normal, pre-injury self at baseline
Measured: Baseline, after 10 treatment sessions (approximately 2 weeks after starting treatment)
Percent change in participant feeling of back to normal, pre-injury self as assessed based on patient rating
Percent change in participant feeling of back to normal, pre-injury self is assessed based on patient rating. Participants will be asked to rate what percent they feel back to their normal, pre-injury self at baseline
Measured: Baseline, after 15 treatment sessions (approximately 3 weeks after starting treatment)
Percent change in participant feeling of back to normal, pre-injury self as assessed based on patient rating
Percent change in participant feeling of back to normal, pre-injury self is assessed based on patient rating. Participants will be asked to rate what percent they feel back to their normal, pre-injury self at baseline
Measured: Baseline, after 20 treatment sessions (approximately 4 weeks after starting treatment)
Percent change in participant feeling of back to normal, pre-injury self as assessed based on patient rating
Percent change in participant feeling of back to normal, pre-injury self is assessed based on patient rating. Participants will be asked to rate what percent they feel back to their normal, pre-injury self at baseline
Measured: Baseline, 1 month post-treatment
Change in psychological/mood symptoms as measured by Brief Symptom Inventory (BSI) scale
Change in psychological/mood symptoms is measured by Brief Symptom Inventory (BSI) scale. The Brief Symptom Inventory (BSI) (secondary outcome): contains 18 items with 3 subscales measuring Depression, Anxiety, and Somatization and total raw score represents the Global Severity Index (GSI). Scores on each of the 3 subscales range from 0-24 and total GSI scores range from 0-72. Higher scores on the subscales and total GSI are indicative of more severe psychological/mood symptoms
Measured: Baseline, immediately after last treatment
Change in psychological/mood symptoms as measured by Brief Symptom Inventory (BSI) scale
Change in psychological/mood symptoms is measured by Brief Symptom Inventory (BSI) scale. The Brief Symptom Inventory (BSI) (secondary outcome): contains 18 items with 3 subscales measuring Depression, Anxiety, and Somatization and total raw score represents the Global Severity Index (GSI). Scores on each of the 3 subscales range from 0-24 and total GSI scores range from 0-72. Higher scores on the subscales and total GSI are indicative of more severe psychological/mood symptoms
Measured: Baseline, 1 month after treatment
Number of participants with adverse events
Safety (Tolerability) of the treatment is assessed by monitoring and evaluating Adverse events (AE)s by Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for 30 days post-treatment
Measured: 1 month after treatment
Number of participants who missed the treatment
The count of participants who missed the treatment is assessed.
Measured: 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2022
- Study start1 Mar 2023
- Primary completion12 May 2025
- Study completion12 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-Concussion SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized between HBOT and control group with a 1:1 allocation ratio, stratified by decade of age and gender via computer generated block randomization with block size of four.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, James Berry, University of Texas Southwestern Medical Center
- Investigators
- James Berry, M.D., Principal investigator, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05643482
- Sponsor's protocol ID
- STU-2022-0697
- Status last verified
- Oct 2025
- First submitted
- 17 Nov 2022
- Last updated
- 14 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hyperbaric Oxygen Therapy for Post-Concussion Syndrome: A Double-Blind, Randomized, Placebo-Controlled Pilot Study
- ClinicalTrials.gov ID
- NCT05643482
- Acronym / sponsor ID
- STU-2022-0697
- Conditions
- Post-Concussion Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 12 May 2025 (actual)
- Study completion
- 12 May 2025 (actual)
- First posted
- 8 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to decrease symptom burden, improve cognitive function, and improve quality of life outcomes in subjects with mild TBI and persisting post-concussion syndrome using Hyperbaric Oxygen Treatment compared to a sham intervention.
Specific Aims:
- Evaluate the efficacy of hyperbaric oxygen treatment to improve outcomes for adults with persisting post-concussion syndrome. Specifically, the investigators hypothesize that a prescribed course of hyperbaric oxygen treatments (HBOT) will improve outcomes and quality of life in adults with persisting symptoms >3 months after injury.
- Decrease symptom burden as measured by the Rivermead Post-Concussion Symptoms Questionnaire (RPQ).
- Improve cognitive function as measured by the National Institutes of Health (NIH) Toolbox Cognition Battery.
- Improve quality of life as measured by the 36-Item Short Form Survey (SF-36).
- Assess the safety and tolerability of hyperbaric oxygen treatments and compliance with treatment in adults with persisting post-concussion syndrome.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomized between HBOT and control group with a 1:1 allocation ratio, stratified by decade of age and gender via computer generated block randomization with block size of four.
| Arm | Type | Receives |
|---|---|---|
| HBOT Arm | Experimental | Device: Hyperbaric Oxygen TreatmentPressurized at 2.0 atmospheres absolute of pressure (ATA) Breathe 100% oxygen 90 minute session, 5 days per week, for 20 sessions |
| Control Arm | Sham comparator | Other: Placebo gasPlacebo Gas Pressurized at 2.0 ATA Breathe placebo gas system of 10.5% oxygen and 89.5% nitrogen to mimic the partial pressure of oxygen breathed in regular air at sea level pressure 90 minute session, 5 days per week, for 20 sessions |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Must have been evaluated within 3 weeks of injury and given a diagnosis of concussion by a medical professional
- Must be experiencing persistent symptoms 3-12 months after injury as defined as having at least symptoms that are moderate to severe (score 3-4) OR at least a total score of 10 with at least 1 symptom rated moderate to severe (3-4) on the Rivermead Post-Concussion Questionnaire (RPQ).
Key exclusion criteria (46 listed)
- Clinically significant cardiac, neurological, psychological/psychiatric, or respiratory impairment in the opinion of the investigators, including but not limited to:
- Pulmonary:
- Cardiac:
- Hematological/Oncological:
- Neurological and Psychological:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hyperbaric Oxygen TreatmentPressurization at 2.0 ATA with 100% oxygen | Device | HBOT Arm |
| Placebo gasPressurization at 2.0 ATA with 10.5% oxygen to mimic normal air | Other | Control Arm |
Primary outcome
Change in symptom burden as measured by the Rivermead Post-Concussion Symptoms Questionnaire-3 (RPQ-3)
Time frame: Baseline, immediately after treatment
Change in symptom burden is measured by the Rivermead Post-Concussion Symptoms Questionnaire-3 (RPQ-3) which is a 16 item questionnaire of common cognitive, behavioral, and physical symptoms experienced following a mTBI. The RPQ is rated on a 0-4 scale with scores ranging from 0-64. Higher levels of endorsement indicate more severe symptoms. The RPQ-3 is the total score of the first three items of the RPQ and includes "headaches," "feelings of dizziness," and "nausea and/or vomiting."
Change in symptom burden as measured by the Rivermead Post-Concussion Symptoms Questionnaire-3 (RPQ-3)
Time frame: Baseline, 1 month after treatment
Change in symptom burden is measured by the Rivermead Post-Concussion Symptoms Questionnaire-3 (RPQ-3) which is a 16 item questionnaire of common cognitive, behavioral, and physical symptoms experienced following a mTBI. The RPQ is rated on a 0-4 scale with scores ranging from 0-64. Higher levels of endorsement indicate more severe symptoms. The RPQ-3 is the total score of the first three items of the RPQ and includes "headaches," "feelings of dizziness," and "nausea and/or vomiting."
19 secondary outcomes
Change in symptom burden as measured by the Rivermead Post-Concussion Symptoms Questionnaire-13 (RPQ-13)
Time frame: Baseline, immediately after last treatment
Change in symptom burden as measured by the Rivermead Post-Concussion Symptoms Questionnaire-13 (RPQ-13)
Time frame: Baseline, 1 month after treatment
Change in quality of life as measured by the Short Form Survey (SF-36)
Time frame: Baseline, immediately after treatment
Change in quality of life as measured by the Short Form Survey (SF-36)
Time frame: Baseline, 1 month
Global Impression of Change (GIC)
Time frame: Baseline, after 5 treatment sessions (approximately 1 week after starting treatment)
Global Impression of Change (GIC)
Time frame: Baseline, after 10 treatment sessions (approximately 2 weeks after starting treatment)
Global Impression of Change (GIC)
Time frame: Baseline, after 15 treatment sessions (approximately 3 weeks after starting treatment)
Global Impression of Change (GIC)
Time frame: Baseline, after 20 treatment sessions (approximately 3 weeks after starting treatment)
Global Impression of Change (GIC)
Time frame: Baseline, 1 month post-treatment
Percentage of participant feeling of back to normal, pre-injury self at baseline as assessed based on patient rating
Time frame: Baseline
Percent change in participant feeling of back to normal, pre-injury self as assessed based on patient rating
Time frame: Baseline, after 5 treatment sessions (approximately 1 week after starting treatment)
Percent change in participant feeling of back to normal, pre-injury self as assessed based on patient rating.
Time frame: Baseline, after 10 treatment sessions (approximately 2 weeks after starting treatment)
Percent change in participant feeling of back to normal, pre-injury self as assessed based on patient rating
Time frame: Baseline, after 15 treatment sessions (approximately 3 weeks after starting treatment)
Percent change in participant feeling of back to normal, pre-injury self as assessed based on patient rating
Time frame: Baseline, after 20 treatment sessions (approximately 4 weeks after starting treatment)
Percent change in participant feeling of back to normal, pre-injury self as assessed based on patient rating
Time frame: Baseline, 1 month post-treatment
Change in psychological/mood symptoms as measured by Brief Symptom Inventory (BSI) scale
Time frame: Baseline, immediately after last treatment
Change in psychological/mood symptoms as measured by Brief Symptom Inventory (BSI) scale
Time frame: Baseline, 1 month after treatment
Number of participants with adverse events
Time frame: 1 month after treatment
Number of participants who missed the treatment
Time frame: 5 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James Berry, M.D. principal investigator
University of Texas Southwestern Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hyperbaric Oxygen Treatment in people with Post-Concussion Syndrome, run by University of Texas Southwestern Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 46 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in symptom burden as measured by the Rivermead Post-Concussion Symptoms Questionnaire-3 (RPQ-3) (time frame: Baseline, immediately after treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2025.