Traumatic Brain InjuryNCT07883668
Cognitive Effects of Hyperbaric Oxygen Therapy (HBOT) After a Traumatic Brain Injury
An observational study of Traumatic Brain Injury and Post-Concussion Syndrome, run by Assaf-Harofeh Medical Center.
Trial summary
This is a retrospective, single-center observational study evaluating the cognitive effects of hyperbaric oxygen therapy (HBOT) in adults who sustained a traumatic brain injury (TBI). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Traumatic Brain Injury, Post-Concussion Syndrome
- What is being tested?
- Hyperbaric Oxygen Therapy - HBOT
- How many people
- 1,000 participants
- Where
- No sites listed yet
- Study dates
- Oct 2026to Aug 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Number of participants: patients who received hyperbaric chamber treatment from January 2008 to 2026, estimated at approximately 1,000 patients.
Who may be able to join
- Patients with chronic neurological deficits following traumatic brain injury of any grade.
- At least 3 months elapsed since the injury.
- Treated at the Sagol Center For Hyperbaric Medicine and Resesrch with a course of HBOT
- Completed at least two cognitive assessments (before and after hyperbaric treatment).
- No other cause of brain damage.
- Aged 18 years or older.
Who cannot join
- 1. Any criteria not detailed in Inclusion criteria is considered exclusion criteria
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
This is a retrospective, single-center observational study evaluating the cognitive effects of hyperbaric oxygen therapy (HBOT) in adults who sustained a traumatic brain injury (TBI). Earlier randomized controlled work at this center demonstrated cognitive improvement after HBOT in patients with chronic deficits following mild TBI. This study evaluates a large sample size and operationalizes HBOT treatment as a continuous variable in the form of a cumulative oxygen dose, something has not been done before. Using the medical records of patients treated at the Sagol Center for Hyperbaric Medicine and Research at Shamir Medical Center between 2008 and 2026, the investigators compare computerized NeuroTrax cognitive assessments obtained before and after HBOT. The investigators quantify within-patient change across the cognitive domains and the Global Cognitive Score, and test whether the magnitude of cognitive change is associated with cumulative oxygen dose, expressed as the area under the pressure-time curve (ATA-minutes). The study includes patients across all TBI severity grades and adjusts for baseline performance, age, sex, and injury severity.
Read the detailed description
Evidence has accumulated in recent years that HBOT can promote brain neuroplasticity and produce neurological improvement in patients after stroke and after traumatic brain injury. A randomized controlled trial conducted at this center showed significant cognitive improvement and improved quality of life among patients with chronic neurological deficits following mild TBI. To date, most studies, including the earlier work at this center, focused on mild TBI, and higher severity grades have not been examined systematically. In addition, treatment protocols have customarily been classified into discrete groups by pressure, and the effect of cumulative oxygen dose treated as a continuous variable on cognitive outcome has not previously been examined.
In this study the investigators retrospectively identify patients with chronic neurological deficits after TBI of any severity who received HBOT at the Sagol Center between January 2008 and 2026 and who completed cognitive assessments before and after treatment. Neurocognitive performance is assessed with the computerized NeuroTrax battery, which yields normalized domain index scores and a Global Cognitive Score on an IQ-like scale (mean 100, standard deviation 15), adjusted for age and education. For each patient the investigators compute a cumulative oxygen dose as the area under the pressure-time curve across all sessions, and derive the proportion of sessions performed at 2.0 ATA as a continuous predictor of dose. the investigators then test the pre-treatment to post-treatment change in cognitive scores and its relationship to cumulative oxygen dose, adjusting for baseline score, age, sex, and TBI severity. Additional analyses assess regression to the mean and time since injury as controls against spontaneous recovery.
- Conditions
- Traumatic Brain Injury, Post-Concussion Syndrome
- Being tested
- Hyperbaric Oxygen Therapy - HBOT
- Medical subject headings
- Brain Injuries, Traumatic, Post-Concussion Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyperbaric Oxygen Therapy - HBOTOther
60 consecutive hyperbaric oxygen treatment (HBOT) sessions, 5 sessions per week within a three months' period 60 consecutive hyperbaric oxygen treatment (HBOT) sessions, 5 sessions per week within a three months' period
| Study group | Role | What they receive |
|---|---|---|
| Adults Treated With HBOT | Retrospective cohort of adults who completed a full treatment series of 60 hyperbaric oxygen therapy (HBOT) sessions at 2 atmospheres absolute (ATA) breathing 100% oxygen, and were approved for a maximal cardiopulmonary exercise testing (CPET). Prticipants underwent pre- and post-treatment cardiopulmonary exercise testing (CPET) and cognitive assessments as part of routine clinical evaluation. Receives: Other: Hyperbaric Oxygen Therapy - HBOT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in NeuroTrax cognitive scores from baseline vs post treatment of HBOT
Ten cognitive outcome measures, comprising the NeuroTrax domain index scores together with the Global Cognitive Score, each normalized to an IQ-like scale (mean 100, standard deviation 15).
Measured: Baseline, up to 8 weeks
Secondary outcomes (3)
Correlation between cumulative oxygen dose and cognitive change
Relationship between the cumulative oxygen dose (ATA-minutes, area under the pressure-time curve) and the magnitude of change in cognitive scores.
Measured: Baseline, up to 8 weeks
Correlation between proportion of sessions at 2.0 ATA and cognitive change
Relationship between the proportion of sessions delivered at 2.0 ATA and the magnitude of change in cognitive scores.
Measured: Baseline, up to 8 weeks
Proportion of patients crossing the clinical threshold
Proportion of patients whose cognitive scores cross a clinical threshold score of 85 from before to after treatment.
Measured: Baseline, up to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2026
- Study startOct 2026 (estimated)
- Primary completionAug 2030 (estimated)
- Study completionAug 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic Brain InjuryStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assaf-Harofeh Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Shay Efrati, Assaf-Harofeh Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07883668
- Sponsor's protocol ID
- 0172-26-ASF
- Status last verified
- Oct 2026
- First submitted
- 16 Sep 2026
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Effects of Hyperbaric Oxygen Therapy (HBOT) After a Traumatic Brain Injury
- ClinicalTrials.gov ID
- NCT07883668
- Acronym / sponsor ID
- 0172-26-ASF
- Conditions
- Traumatic Brain Injury, Post-Concussion Syndrome
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Assaf-Harofeh Medical CenterOther government
- Study start
- Oct 2026 (estimated)
- Primary completion
- Aug 2030 (estimated)
- Study completion
- Aug 2030 (estimated)
- First posted
- 20 Oct 2026 (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.
This is a retrospective, single-center observational study evaluating the cognitive effects of hyperbaric oxygen therapy (HBOT) in adults who sustained a traumatic brain injury (TBI). Earlier randomized controlled work at this center demonstrated cognitive improvement after HBOT in patients with chronic deficits following mild TBI. This study evaluates a large sample size and operationalizes HBOT treatment as a continuous variable in the form of a cumulative oxygen dose, something has not been done before. Using the medical records of patients treated at the Sagol Center for Hyperbaric Medicine and Research at Shamir Medical Center between 2008 and 2026, the investigators compare computerized NeuroTrax cognitive assessments obtained before and after HBOT. The investigators quantify within-patient change across the cognitive domains and the Global Cognitive Score, and test whether the magnitude of cognitive change is associated with cumulative oxygen dose, expressed as the area under the pressure-time curve (ATA-minutes). The study includes patients across all TBI severity grades and adjusts for baseline performance, age, sex, and injury severity.
Detailed description
Evidence has accumulated in recent years that HBOT can promote brain neuroplasticity and produce neurological improvement in patients after stroke and after traumatic brain injury. A randomized controlled trial conducted at this center showed significant cognitive improvement and improved quality of life among patients with chronic neurological deficits following mild TBI. To date, most studies, including the earlier work at this center, focused on mild TBI, and higher severity grades have not been examined systematically. In addition, treatment protocols have customarily been classified into discrete groups by pressure, and the effect of cumulative oxygen dose treated as a continuous variable on cognitive outcome has not previously been examined.
In this study the investigators retrospectively identify patients with chronic neurological deficits after TBI of any severity who received HBOT at the Sagol Center between January 2008 and 2026 and who completed cognitive assessments before and after treatment. Neurocognitive performance is assessed with the computerized NeuroTrax battery, which yields normalized domain index scores and a Global Cognitive Score on an IQ-like scale (mean 100, standard deviation 15), adjusted for age and education. For each patient the investigators compute a cumulative oxygen dose as the area under the pressure-time curve across all sessions, and derive the proportion of sessions performed at 2.0 ATA as a continuous predictor of dose. the investigators then test the pre-treatment to post-treatment change in cognitive scores and its relationship to cumulative oxygen dose, adjusting for baseline score, age, sex, and TBI severity. Additional analyses assess regression to the mean and time since injury as controls against spontaneous recovery.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adults Treated With HBOT | – | Other: Hyperbaric Oxygen Therapy - HBOTRetrospective cohort of adults who completed a full treatment series of 60 hyperbaric oxygen therapy (HBOT) sessions at 2 atmospheres absolute (ATA) breathing 100% oxygen, and were approved for a maximal cardiopulmonary exercise testing (CPET). Prticipants underwent pre- and post-treatment cardiopulmonary exercise testing (CPET) and cognitive assessments as part of routine clinical evaluation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Number of participants: patients who received hyperbaric chamber treatment from January 2008 to 2026, estimated at approximately 1,000 patients.
Key inclusion criteria (6 listed)
- Patients with chronic neurological deficits following traumatic brain injury of any grade.
- At least 3 months elapsed since the injury.
- Treated at the Sagol Center For Hyperbaric Medicine and Resesrch with a course of HBOT
- Completed at least two cognitive assessments (before and after hyperbaric treatment).
- No other cause of brain damage.
Key exclusion criteria (1 listed)
- 1. Any criteria not detailed in Inclusion criteria is considered exclusion criteria
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 Therapy - HBOT60 consecutive hyperbaric oxygen treatment (HBOT) sessions, 5 sessions per week within a three months' period 60 consecutive hyperbaric oxygen treatment (HBOT) sessions, 5 sessions per week within a three months' period | Other | Adults Treated With HBOT |
Primary outcome
Change in NeuroTrax cognitive scores from baseline vs post treatment of HBOT
Time frame: Baseline, up to 8 weeks
Ten cognitive outcome measures, comprising the NeuroTrax domain index scores together with the Global Cognitive Score, each normalized to an IQ-like scale (mean 100, standard deviation 15).
3 secondary outcomes
Correlation between cumulative oxygen dose and cognitive change
Time frame: Baseline, up to 8 weeks
Correlation between proportion of sessions at 2.0 ATA and cognitive change
Time frame: Baseline, up to 8 weeks
Proportion of patients crossing the clinical threshold
Time frame: Baseline, up to 8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2026.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Traumatic Brain Injury and Post-Concussion Syndrome, run by Assaf-Harofeh Medical Center.
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 6 inclusion and 1 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: opening soon, as of the sponsor's last update on 23 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shay Efrati, prof (+972-8-9779393, efratishai@outlook.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in NeuroTrax cognitive scores from baseline vs post treatment of HBOT (time frame: Baseline, up to 8 weeks). 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 23 Oct 2026.