An observational study in Traumatic Brain Injury and Post-Concussion Syndrome, sponsored by Assaf-Harofeh Medical Center. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-23.
Sponsored by Assaf-Harofeh Medical Center · Observational
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.
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.
1,818 studies on the registry are indexed under Brain Injuries, Traumatic; 460 are open to participants now.
This study's planned enrollment of 1,000 is above the median of 119 across 579 observational studies indexed under Brain Injuries, Traumatic.
Browse Brain Injuries, Traumatic studies →Assaf-Harofeh Medical Center is the lead sponsor of 267 studies on the registry; 43 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Number of participants: patients who received hyperbaric chamber treatment from January 2008 to 2026, estimated at approximately 1,000 patients.
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Exclusion Criteria:
1. Any criteria not detailed in Inclusion criteria is considered exclusion criteria
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.
Other: Hyperbaric Oxygen Therapy - HBOT
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
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).
Time frame: Baseline, up to 8 weeks
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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline, up to 8 weeks
No study locations are listed for this record.
Start is estimated for Oct 2026; primary completion for Aug 2030, 46 months later.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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