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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAssaf-Harofeh Medical Center

About this trial

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 criteria

This trial accepts healthy volunteers

Qualifiers

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. -

Disqualifiers

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

Trial 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.

Trial design

Design model

Cohort

Time perspective

Retrospective

Treatments tested in this trial

Not listed

Trial groups

100 Participants
are grouped into 1 trial group
Group A: Hyperbaric oxygen therapy (HBOT) active treatment

Trial outcomes

Primary outcomes

1

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

Time frame
Change from Baseline immediately after the intervention
2

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

Time frame
Change from Baseline immediately after the intervention
3

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.

Time frame
Change from Baseline immediately after the intervention
4

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.

Time frame
Change from Baseline immediately after the intervention

Secondary outcomes

Other outcomes

Locations

1

Map coordinates are unavailable for these locations. Locations are shown below instead.

The Sagol Center for Hyperbaric Medicine and Research Shamir Medical Center (Assaf Harofeh)Recruiting70300, ZrifinIsraelIsrael

Sponsors and contacts

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