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NCT07883668

Cognitive Effects of Hyperbaric Oxygen Therapy (HBOT) After a Traumatic Brain Injury

Sponsor: Assaf-Harofeh Medical Center

View on ClinicalTrials.gov

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). 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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

1000

Start Date

2026-10

Completion Date

2030-08

Last Updated

2026-10-23

Healthy Volunteers

No

Interventions

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