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.

Study Protocol Summary:

Long-term effect of hyperbaric oxygen therapy on cognitive functions in patients after traumatic brain injury

Study number: 0172-21-ASF Protocol number: 0172-21-ASF Protocol date: July 12, 2021 Protocol version: 1.0 Study type: No investigational product

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].

Participant recruitment procedure:

Participants who were treated with a series of hyperbaric chamber treatments at Shamir Medical Center between 2017 and 2021 will be identified. Patients will be invited by telephone to participate in the study; those who agree will be summoned to the Sagol Center, will sign an informed consent form, and will undergo a cognitive assessment.

Detailed study plan and clinical follow-up (during and after treatment):

Eligible participants will be invited for an assessment visit that will include: signing the informed consent form, self-completion of validated computerized questionnaires, and a computerized cognitive assessment test. In addition, cognitive assessment results performed before and after the hyperbaric treatment series will be extracted from the patients' medical records, as well as demographic data, comorbidities, type and severity of the injury, time since the event, symptoms and changes reported during the hyperbaric treatment.

Subjects were over 18 years old at the time of hyperbaric treatment. Subjects with chronic neurological deficits after traumatic brain injury of any severity who received hyperbaric chamber treatment.

Completed a series of at least 50 hyperbaric chamber treatments at Shamir Medical Center and underwent two computerized cognitive tests (before and after the treatment series).

Duration of treatment per participant and total study duration including post-study follow-up:

12 months

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

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.