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 volunteersQualifiers
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
Cohort
Retrospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
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
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
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.
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.
Locations
1Map coordinates are unavailable for these locations. Locations are shown below instead.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.