Phase
Condition
Brain Injury
Neurologic Disorders
Treatment
Sham device
BioFlex Dualport System
Clinical Study ID
Ages > 19 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Male or female, at least 19 years of age or older
Diagnosis of persistent post-concussional syndrome after ≥3 months of traumaticbrain injury, based on the ICD-10 criteria. This diagnosis should be given to thepatient from a clinical practitioner. ICD-10 clinical criteria require a history ofTBI and the presence of three or more of the following eight symptoms: 1) headache,
- dizziness, 3) fatigue, 4) irritability, 5) insomnia, 6) concentration or 7)memory difficulty, and 8) intolerance of stress, emotion, or alcohol.
Current pharmacologic management can remain stable throughout the protocol.
Fluent in English
Able to understand the informed consent form, study procedures and willing toparticipate in study.
Exclusion
Exclusion Criteria:
Malignant skin carcinoma within the treatment area (neck and cranium)
Intake of photosensitizing medication.
Prior history of PBMT therapy
Current diagnosis of severe anxiety (or score of ≥15 on the GAD-7), severedepression (or score of ≥20 on the PHQ-9), schizophrenia or bipolar disorder
History of other major neurological disorder (brain cancer, dementia, multiplesclerosis, stroke)
Diagnosed epilepsy or history of seizures not effectively controlled by medications
Exposed to an investigational drug or device 30 days prior to starting the study, orconcurrent use of an investigational drug or device while enrolled in the study
Pregnant, suspected to be pregnant or planning to become pregnant during the study
Contraindicated for the NeuroCatch® Platform 2, including:
9.1. Requires the use of hearing aids or a cochlear implant 9.2. Diagnosed with tinnitus that is currently active 9.3. Has temporary damage to hearing (e.g. punctured ear drum) 9.4. Unable to detect a 740Hz tone played at 85dB in both ears. 9.5. Implanted pacemaker or implanted electrical stimulators 9.6. Metal or plastic implants in the skull, excluding dental/facial implants 9.7. Unhealthy scalp (apparent open wounds and/or bruised or weakened skin) 9.8. Previous exposure to the NeuroCatch® Platform 2 audio sequences in the last 3 months
Study Design
Connect with a study center
Center for Neurology Studies
Surrey, British Columbia V3V 0C6
CanadaSite Not Available
Meditech Rehabilitation Centre
Etobicoke, Ontario M8W 4W3
CanadaSite Not Available
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