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

NCT07430150 | Recruiting DMC

• 1 other identifier: 0172-21-ASF
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

TBI (Traumatic Brain Injury)

Keywords

Hyperbaric Therapy

Outcome Measures

Primary Outcomes (4)

• 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

  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

  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.

  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.

  Change from Baseline immediately after the intervention

Study Arms (1)

Hyperbaric oxygen therapy (HBOT) active treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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.

You may qualify if:

• 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. -

You may not qualify if:

• 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

Sponsors & Collaborators

• Assaf-Harofeh Medical Center: lead

Study Sites (1)

The Sagol Center for Hyperbaric Medicine and Research Shamir Medical Center (Assaf Harofeh)

Zrifin, 70300, Israel

RECRUITING

MeSH Terms

Conditions

Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Shai Efrati, MD

  Asaf-Harofhe MC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shai Efrati, MD

CONTACT

972549212866; efratishai@outlook.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Proffessor

Study Record Dates

• First Submitted: February 18, 2026
• First Posted: February 24, 2026
• Study Start: December 28, 2021
• Primary Completion (Estimated): January 1, 2030
• Study Completion (Estimated): January 1, 2030
• Last Updated: April 21, 2026

Record last verified: 2026-04

Locations

IL (1)