RecruitingNCT07430150

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


Sponsor

Assaf-Harofeh Medical Center

Enrollment

100 participants

Start Date

Dec 28, 2021

Study Type

OBSERVATIONAL

Conditions

Summary

Purpose of the trial, rationale including definition of quantitative measures and description of participant recruitment: Background and rationale: Traumatic brain injury (TBI) is one of the most common causes of disability and death in the general population \[1\]. Recent studies have shown that hyperbaric oxygen therapy helps improve cognitive function and quality of life in patients with chronic neurological deficits after traumatic brain injury of various severities, due to changes in brain neuroplasticity \[2-4\]. To date, only a few studies have examined the sustained effect of hyperbaric therapy on somatic, cognitive, or emotional symptoms in this population. Only two studies examined persistent effects in the range of 6 to 12 months after the end of a series of treatments \[5-6\]. Study objective: The aim of the current study is 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.


Eligibility

Min Age: 18 Years

Inclusion Criteria4

  • 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 Criteria5

  • 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

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Locations(1)

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

Zrifin, Israel

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NCT07430150


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