Long-lasting effects of hyperbaric oxygen therapy on thinking after traumatic brain injury

Long Lasting Effect of Hyperbaric Oxygen Therapy on Cognitive Function in Traumatic Brain Injury Patients

This project will see if people with traumatic brain injury who completed a course of hyperbaric oxygen therapy 1–4 years ago still have improved thinking and memory.

Quick facts

• Study type: Observational
• Enrollment: 100 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Assaf-Harofeh Medical Center (Government)
• Locations: 1 site (Zrifin)
• Trial ID: NCT07430150 on ClinicalTrials.gov

What this trial studies

This observational study will identify adults with prior traumatic brain injury who completed a 60-session hyperbaric oxygen course at the Sagol Center between 2017 and 2021 and invite them for follow-up cognitive testing. Participants who agree will sign informed consent and undergo a computerized Neurotrax cognitive evaluation at the Sagol Center. The goal is to measure cognitive performance 1–4 years after treatment to determine whether previously reported benefits persist long-term. Patients with intervening head injuries, neurodegenerative disease, major psychiatric disorders, active malignancy, or chronic cognition-impairing medications are excluded.

Who should consider this trial

Good fit: Adults (age ≥18) with a diagnosed traumatic brain injury who completed a 60-session hyperbaric oxygen treatment at the Sagol Center (Shamir Medical Center) and previously had Neurotrax cognitive testing are ideal candidates.

Not a fit: People who had new head trauma, stroke, neurodegenerative disease, major psychiatric illness, active cancer, chronic use of cognition‑compromising medications, or who cannot complete computerized testing are unlikely to benefit from this follow-up assessment.

Why it matters

Potential benefit: If positive, the findings could support that hyperbaric oxygen therapy provides lasting improvements in thinking, memory, and related quality of life after traumatic brain injury.

How similar studies have performed: Previous studies have reported cognitive and quality-of-life improvements after hyperbaric oxygen therapy, but only a few have examined effects beyond 6–12 months, so long-term durability remains less well established.

Eligibility criteria

Inclusion Criteria:

1. Diagnosed with traumatic brain injury
2. Age 18 years or older at treatment
3. 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.
4. Willing and able to sign an informed consent. -

Exclusion Criteria:

1. An inability to perform a neurocognitive computerized test.
2. Any head trauma, neurodegenerative diseases or CVA after hyperbaric treatment completion.
3. Diagnosis of a psychiatric disorder including: major depression, schizophrenia, bipolar disorder
4. Active malignancy
5. Chronic use of medications that may compromise cognitive function

Where this trial is running

Zrifin

• The Sagol Center for Hyperbaric Medicine and Research Shamir Medical Center (Assaf Harofeh) — Zrifin, Israel (Recruiting)

Study contacts

• Principal investigator: Shai Efrati, MD — Asaf-Harofhe MC
• Study coordinator: Shai Efrati, MD

Conditions TBI; Hyperbaric Therapy