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
Study Type
OBSERVATIONAL
Enrollment
100
The Sagol Center for Hyperbaric Medicine and Research Shamir Medical Center (Assaf Harofeh)
Zrifin, Israel
RECRUITINGNeuroTrax 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
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
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
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.
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Time frame: Change from Baseline immediately after the intervention