TBI (Traumatic Brain Injury)NCT04287283
Cognitive Profile of Patients at the Sagol Center for Hyperbaric Medicine and Research
An observational study of TBI (Traumatic Brain Injury) and Stroke, run by Assaf-Harofeh Medical Center at 1 site in Israel.
Trial summary
In the investigator's institute there is ongoing treatment of different patients with cognitive deficits using Hyperbaric oxygen therapy (HBOT). These patients undergo neuro-cognitive function computerized tests before and after treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- TBI (Traumatic Brain Injury), Stroke, Fibromyalgia
- What is being tested?
- Hyperbaric Oxygen
- How many people
- 2,500 participants
- Where
- 1 siteIsrael
- Study dates
- Jan 2008to Dec 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: Retrospective analysis of patients suffering from chronic neuro-cognitive damage or complaints treated at Sagol center for hyperbaric medicine and research, Shamir (Assaf Harofeh) Medical Center, Israel since 2008 .
Who may be able to join
- Patients included if they completed at least two neuro-cognitive computerized tests, before and after HBOT
Who cannot join
- Patients who were not able to complete two cognitive tests
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Profile of Cognitive Function of Patients Who Had Neurocognitive Evaluation at the Sagol Center for Hyperbaric Medicine and Research
In the investigator's institute there is ongoing treatment of different patients with cognitive deficits using Hyperbaric oxygen therapy (HBOT). These patients undergo neuro-cognitive function computerized tests before and after treatment.
The aim of this study was to retrospectively evaluate the cognitive changes before and after HBOT in different patients populations.
Read the detailed description
Retrospective analysis of patients suffering from chronic neuro-cognitive deficits due to different conditions, treated at Sagol center for hyperbaric medicine and research, Shamir (Assaf Harofeh) Medical Center, Israel
Patients included if they had at least two neurocognitive tests, before and after Hyperbaric Oxygen Therapy (HBOT). The study was approved by the institutional review board of the hospital.
Patients were treated with 40-60 daily hyperbaric sessions, 5 days per week. Each session consists of 90 minutes exposure to 100% oxygen at 1.5-2 ATA.
- Conditions
- TBI (Traumatic Brain Injury), Stroke, Fibromyalgia, Aging
- Being tested
- Hyperbaric Oxygen
- Medical subject headings
- Brain Injuries, Traumatic, Stroke, Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyperbaric OxygenOther
40-60 daily hyperbaric sessions, 5 days per week. Each session consists of 90 minutes exposure to 100% oxygen at 1.5-2 ATA.
| Study group | Role | What they receive |
|---|---|---|
| HBOT | Patients with chronic brain injury or cognitive complaints that have been treated with Hyperbaric oxygen therapy and underwent computerized cognitive tests before and after the treatment Receives: Other: Hyperbaric Oxygen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in neurocognitive scores
change in scores in a computerized neuro-cognitive test, "IQ-scale" score, normalized for age and education, with mean=100 and SD=15 points in healthy population, higher score implies better results.
Measured: baseline and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2020
- Study startJan 2008
- Primary completionDec 2030 (estimated)
- Study completionDec 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
- 2,500 participants (actual)
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
- NCT04287283
- Sponsor's protocol ID
- 0267-19
- Status last verified
- Apr 2026
- First submitted
- 25 Feb 2020
- Last updated
- 21 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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
- The Profile of Cognitive Function of Patients Who Had Neurocognitive Evaluation at the Sagol Center for Hyperbaric Medicine and Research
- ClinicalTrials.gov ID
- NCT04287283
- Acronym / sponsor ID
- 0267-19
- Conditions
- TBI (Traumatic Brain Injury), Stroke, Fibromyalgia, Aging
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 2,500 participants (actual)
- Lead sponsor
- Assaf-Harofeh Medical CenterOther government
- Study start
- Jan 2008 (actual)
- Primary completion
- Dec 2030 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 27 Feb 2020 (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.
In the investigator's institute there is ongoing treatment of different patients with cognitive deficits using Hyperbaric oxygen therapy (HBOT). These patients undergo neuro-cognitive function computerized tests before and after treatment.
The aim of this study was to retrospectively evaluate the cognitive changes before and after HBOT in different patients populations.
Detailed description
Retrospective analysis of patients suffering from chronic neuro-cognitive deficits due to different conditions, treated at Sagol center for hyperbaric medicine and research, Shamir (Assaf Harofeh) Medical Center, Israel
Patients included if they had at least two neurocognitive tests, before and after Hyperbaric Oxygen Therapy (HBOT). The study was approved by the institutional review board of the hospital.
Patients were treated with 40-60 daily hyperbaric sessions, 5 days per week. Each session consists of 90 minutes exposure to 100% oxygen at 1.5-2 ATA.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HBOT | – | Other: Hyperbaric OxygenPatients with chronic brain injury or cognitive complaints that have been treated with Hyperbaric oxygen therapy and underwent computerized cognitive tests before and after the treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Retrospective analysis of patients suffering from chronic neuro-cognitive damage or complaints treated at Sagol center for hyperbaric medicine and research, Shamir (Assaf Harofeh) Medical Center, Israel since 2008 .
Key inclusion criteria (1 listed)
- Patients included if they completed at least two neuro-cognitive computerized tests, before and after HBOT
Key exclusion criteria (1 listed)
- Patients who were not able to complete two cognitive tests
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 Oxygen40-60 daily hyperbaric sessions, 5 days per week. Each session consists of 90 minutes exposure to 100% oxygen at 1.5-2 ATA. | Other | HBOT |
Primary outcome
Change in neurocognitive scores
Time frame: baseline and 12 weeks
change in scores in a computerized neuro-cognitive test, "IQ-scale" score, normalized for age and education, with mean=100 and SD=15 points in healthy population, higher score implies better results.
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.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
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) and Stroke, 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 1 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: under way, not looking for participants, 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?
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 neurocognitive scores (time frame: baseline and 12 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 21 Apr 2026.