RecruitingNot Applicable

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

Israel100 participantsStarted 2021-12-28

Plain-language 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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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. -

Exclusion criteria

✕. 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

What they're measuring

NeuroTrax cognitive battery test

Timeframe: Change from Baseline immediately after the intervention

CANTAB cognitive battery test

Timeframe: Change from Baseline immediately after the intervention

Quality of Life: Short Form (36) Health Survey Questionnaire

Timeframe: Change from Baseline immediately after the intervention

Post-concussion syndrome symptoms: BC-PSI Questionnaire

Timeframe: Change from Baseline immediately after the intervention

Trial details

NCT IDNCT07430150

SponsorAssaf-Harofeh Medical Center

Sponsor typeOTHER_GOV

Study typeOBSERVATIONAL

Primary completion2030-01

Contact for this trial

Shai Efrati, MD

972549212866 efratishai@outlook.com

View on ClinicalTrials.gov More TBI (Traumatic Brain Injury) trials

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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. -

Exclusion criteria

✕. 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

What they're measuring

NeuroTrax cognitive battery test

Timeframe: Change from Baseline immediately after the intervention

CANTAB cognitive battery test

Timeframe: Change from Baseline immediately after the intervention

Quality of Life: Short Form (36) Health Survey Questionnaire

Timeframe: Change from Baseline immediately after the intervention

Post-concussion syndrome symptoms: BC-PSI Questionnaire

Timeframe: Change from Baseline immediately after the intervention