TBI (Traumatic Brain Injury)NCT07430150
Long Lasting Effect of Hyperbaric Oxygen Therapy on Cognitive Function in Traumatic Brain Injury Patients
An observational study of TBI (Traumatic Brain Injury), run by Assaf-Harofeh Medical Center at 1 site in Israel.
Trial summary
To evaluate the cognitive functions of patients who suffered brain injury due to traumatic head injury and were previously treated in a hyperbaric chamber between one and four years after the end of treatment. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- TBI (Traumatic Brain Injury)
- How many people
- 100 participants
- Where
- 1 siteIsrael
- Study dates
- 28 Dec 2021to Jan 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study population will include 100 participants, male and female, aged 18 years or older, who have been diagnosed with TBI and meet the following inclusion/exclusion criteria. Patients will be recruited for the study from the Shamir (Assaf Harofeh) Medical Center database.
Who may be able to join
- Diagnosed with traumatic brain injury
- Age 18 years or older at treatment
- Completed a 60 session hyperbaric treatment course at the Sagol Center for Hyperbaric Medicine and Research, Shamir Medical Center (Assaf Harofeh), and performed a neurocognitive evaluation by the computerized test Neurotrax.
- Willing and able to sign an informed consent. -
Who cannot join
- An inability to perform a neurocognitive computerized test.
- Any head trauma, neurodegenerative diseases or CVA after hyperbaric treatment completion.
- Diagnosis of a psychiatric disorder including: major depression, schizophrenia, bipolar disorder
- Active malignancy
- Chronic use of medications that may compromise cognitive function
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Israel1 site, 1 recruiting
- Recruiting
The Sagol Center for Hyperbaric Medicine and Research Shamir Medical Center (Assaf Harofeh)
Zrifin, 70300
Shai Efrati, Prof, 972-8-9779393, efratishai@outlook.com
About this study
To evaluate the cognitive functions of patients who suffered brain injury due to traumatic head injury and were previously treated in a hyperbaric chamber between one and four years after the end of treatment.
Read the detailed description
Study Protocol Summary:
Long-term effect of hyperbaric oxygen therapy on cognitive functions in patients after traumatic brain injury
Study number: 0172-21-ASF Protocol number: 0172-21-ASF Protocol date: July 12, 2021 Protocol version: 1.0 Study type: No investigational product
Purpose of the trial, rationale including definition of quantitative measures and description of participant recruitment:
Background and rationale:
Traumatic brain injury (TBI) is one of the most common causes of disability and death in the general population [1]. Recent studies have shown that hyperbaric oxygen therapy helps improve cognitive function and quality of life in patients with chronic neurological deficits after traumatic brain injury of various severities, due to changes in brain neuroplasticity [2-4]. To date, only a few studies have examined the sustained effect of hyperbaric therapy on somatic, cognitive, or emotional symptoms in this population. Only two studies examined persistent effects in the range of 6 to 12 months after the end of a series of treatments [5-6].
Participant recruitment procedure:
Participants who were treated with a series of hyperbaric chamber treatments at Shamir Medical Center between 2017 and 2021 will be identified. Patients will be invited by telephone to participate in the study; those who agree will be summoned to the Sagol Center, will sign an informed consent form, and will undergo a cognitive assessment.
Detailed study plan and clinical follow-up (during and after treatment):
Eligible participants will be invited for an assessment visit that will include: signing the informed consent form, self-completion of validated computerized questionnaires, and a computerized cognitive assessment test. In addition, cognitive assessment results performed before and after the hyperbaric treatment series will be extracted from the patients' medical records, as well as demographic data, comorbidities, type and severity of the injury, time since the event, symptoms and changes reported during the hyperbaric treatment.
Subjects were over 18 years old at the time of hyperbaric treatment. Subjects with chronic neurological deficits after traumatic brain injury of any severity who received hyperbaric chamber treatment.
Completed a series of at least 50 hyperbaric chamber treatments at Shamir Medical Center and underwent two computerized cognitive tests (before and after the treatment series).
Duration of treatment per participant and total study duration including post-study follow-up:
12 months
- Conditions
- TBI (Traumatic Brain Injury)
- Keywords
- Hyperbaric Therapy
- Medical subject headings
- Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Hyperbaric oxygen therapy (HBOT) active treatment | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
NeuroTrax cognitive battery test
Cognitive function will be evaluated using the NeuroTrax (Mindstreams) cognitive computerized cognitive testing battery (NeuroTrax Corporation, Bellaire, TX) [70]. This assessment comprises of several cognitive tests that evaluate various aspects of brain capabilities
Measured: Change from Baseline immediately after the intervention
CANTAB cognitive battery test
Subjects' cognitive functions will also be assessed by CANTAB computerized cognitive tests (Cambrdige cognition , England) [72]. The CANTAB is a semiautomated test battery which can be administered on a laptop PC and more recently has been modified for administration on a handheld tablet
Measured: Change from Baseline immediately after the intervention
Quality of Life: Short Form (36) Health Survey Questionnaire
SF-36 is a set of generic, coherent, and easily administered quality-of-life measures [75]. These measures rely upon patient self-reporting and are now widely utilized by researchers, managed care organizations and by Medicare for routine monitoring and assessment of care outcomes in adult patients. It assesses health-related quality of life across eight domains. All eight standard domain scales are commonly transformed to a 0-100 scale, where higher scores indicate better health status / quality of life.
Measured: Change from Baseline immediately after the intervention
Post-concussion syndrome symptoms: BC-PSI Questionnaire
The BC-PSI is a 16-item measure designed to assess the presence and severity of postconcussion symptoms [76]. The test was based on ICD-10 criteria for PCS, and requires the patient to rate the frequency and intensity of 13 symptoms (i.e., headaches, dizziness or light-headedness, nausea or feeling sick, fatigue, sensitivity to noises, irritability, sadness, nervousness or tension, temper problems, poor concentration, memory problems, reading difficulty, and sleep disturbance), and the effect of three life problems on daily living (i.e., greater present vs. past effects of alcohol consumption, worrying and dwelling on symptoms, and self-perception of brain damage). The three life problems are rated on a scale from 1 to 5, where 1 = not at all and 5 = very much.
Measured: Change from Baseline immediately after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2026
- Study start28 Dec 2021
- Primary completionJan 2030 (estimated)
- Study completionJan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TBI (Traumatic Brain Injury)Studies 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
- 100 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
- Investigators
- Shai Efrati, MD, Principal investigator, Asaf-Harofhe MC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07430150
- Sponsor's protocol ID
- 0172-21-ASF
- Status last verified
- Apr 2026
- First submitted
- 18 Feb 2026
- Last updated
- 21 Apr 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 21 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long Lasting Effect of Hyperbaric Oxygen Therapy on Cognitive Function in Traumatic Brain Injury Patients
- ClinicalTrials.gov ID
- NCT07430150
- Acronym / sponsor ID
- 0172-21-ASF
- Conditions
- TBI (Traumatic Brain Injury)
- Keywords
- Hyperbaric Therapy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assaf-Harofeh Medical CenterOther government
- Study start
- 28 Dec 2021 (actual)
- Primary completion
- Jan 2030 (estimated)
- Study completion
- Jan 2030 (estimated)
- First posted
- 24 Feb 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.
To evaluate the cognitive functions of patients who suffered brain injury due to traumatic head injury and were previously treated in a hyperbaric chamber between one and four years after the end of treatment.
Detailed description
Study Protocol Summary:
Long-term effect of hyperbaric oxygen therapy on cognitive functions in patients after traumatic brain injury
Study number: 0172-21-ASF Protocol number: 0172-21-ASF Protocol date: July 12, 2021 Protocol version: 1.0 Study type: No investigational product
Purpose of the trial, rationale including definition of quantitative measures and description of participant recruitment:
Background and rationale:
Traumatic brain injury (TBI) is one of the most common causes of disability and death in the general population [1]. Recent studies have shown that hyperbaric oxygen therapy helps improve cognitive function and quality of life in patients with chronic neurological deficits after traumatic brain injury of various severities, due to changes in brain neuroplasticity [2-4]. To date, only a few studies have examined the sustained effect of hyperbaric therapy on somatic, cognitive, or emotional symptoms in this population. Only two studies examined persistent effects in the range of 6 to 12 months after the end of a series of treatments [5-6].
Participant recruitment procedure:
Participants who were treated with a series of hyperbaric chamber treatments at Shamir Medical Center between 2017 and 2021 will be identified. Patients will be invited by telephone to participate in the study; those who agree will be summoned to the Sagol Center, will sign an informed consent form, and will undergo a cognitive assessment.
Detailed study plan and clinical follow-up (during and after treatment):
Eligible participants will be invited for an assessment visit that will include: signing the informed consent form, self-completion of validated computerized questionnaires, and a computerized cognitive assessment test. In addition, cognitive assessment results performed before and after the hyperbaric treatment series will be extracted from the patients' medical records, as well as demographic data, comorbidities, type and severity of the injury, time since the event, symptoms and changes reported during the hyperbaric treatment.
Subjects were over 18 years old at the time of hyperbaric treatment. Subjects with chronic neurological deficits after traumatic brain injury of any severity who received hyperbaric chamber treatment.
Completed a series of at least 50 hyperbaric chamber treatments at Shamir Medical Center and underwent two computerized cognitive tests (before and after the treatment series).
Duration of treatment per participant and total study duration including post-study follow-up:
12 months
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hyperbaric oxygen therapy (HBOT) active treatment | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will include 100 participants, male and female, aged 18 years or older, who have been diagnosed with TBI and meet the following inclusion/exclusion criteria. Patients will be recruited for the study from the Shamir (Assaf Harofeh) Medical Center database.
Key inclusion criteria (4 listed)
- Diagnosed with traumatic brain injury
- Age 18 years or older at treatment
- Completed a 60 session hyperbaric treatment course at the Sagol Center for Hyperbaric Medicine and Research, Shamir Medical Center (Assaf Harofeh), and performed a neurocognitive evaluation by the computerized test Neurotrax.
- Willing and able to sign an informed consent. -
Key exclusion criteria (5 listed)
- An inability to perform a neurocognitive computerized test.
- Any head trauma, neurodegenerative diseases or CVA after hyperbaric treatment completion.
- Diagnosis of a psychiatric disorder including: major depression, schizophrenia, bipolar disorder
- Active malignancy
- Chronic use of medications that may compromise cognitive function
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
NeuroTrax cognitive battery test
Time frame: Change from Baseline immediately after the intervention
Cognitive function will be evaluated using the NeuroTrax (Mindstreams) cognitive computerized cognitive testing battery (NeuroTrax Corporation, Bellaire, TX) [70]. This assessment comprises of several cognitive tests that evaluate various aspects of brain capabilities
CANTAB cognitive battery test
Time frame: Change from Baseline immediately after the intervention
Subjects' cognitive functions will also be assessed by CANTAB computerized cognitive tests (Cambrdige cognition , England) [72]. The CANTAB is a semiautomated test battery which can be administered on a laptop PC and more recently has been modified for administration on a handheld tablet
Quality of Life: Short Form (36) Health Survey Questionnaire
Time frame: Change from Baseline immediately after the intervention
SF-36 is a set of generic, coherent, and easily administered quality-of-life measures [75]. These measures rely upon patient self-reporting and are now widely utilized by researchers, managed care organizations and by Medicare for routine monitoring and assessment of care outcomes in adult patients. It assesses health-related quality of life across eight domains. All eight standard domain scales are commonly transformed to a 0-100 scale, where higher scores indicate better health status / quality of life.
Post-concussion syndrome symptoms: BC-PSI Questionnaire
Time frame: Change from Baseline immediately after the intervention
The BC-PSI is a 16-item measure designed to assess the presence and severity of postconcussion symptoms [76]. The test was based on ICD-10 criteria for PCS, and requires the patient to rate the frequency and intensity of 13 symptoms (i.e., headaches, dizziness or light-headedness, nausea or feeling sick, fatigue, sensitivity to noises, irritability, sadness, nervousness or tension, temper problems, poor concentration, memory problems, reading difficulty, and sleep disturbance), and the effect of three life problems on daily living (i.e., greater present vs. past effects of alcohol consumption, worrying and dwelling on symptoms, and self-perception of brain damage). The three life problems are rated on a scale from 1 to 5, where 1 = not at all and 5 = very much.
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 21 Apr 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.
Shai Efrati, MD principal investigator
Asaf-Harofhe MC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of TBI (Traumatic Brain Injury), run by Assaf-Harofeh Medical Center at 1 site in Israel.
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 4 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 21 Apr 2026. 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 Israel. 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. 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 Shai Efrati, MD (972549212866, efratishai@outlook.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
NeuroTrax cognitive battery test (time frame: Change from Baseline immediately after the intervention). The study lists 4 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 21 Apr 2026.