An interventional study of BioFlex Dualport System and Sham device in Post-Concussive Syndrome, Chronic, Post-Concussion Syndrome and Mild Traumatic Brain Injury, sponsored by Dr George Medvedev. Completed at 2 sites in Canada. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2024-05-29.
Sponsored by Dr George Medvedev · Not applicable, Interventional, and Treatment
Photobiomodulation therapy (PBMT) uses light to influence the mitochondria of cells. PBMT of the brain enhances the metabolic capacity of neurons and stimulates anti-inflammatory, anti-apoptotic, and antioxidant responses, as well as neurogenesis and synaptogenesis. Its therapeutic role in disorders such as dementia and Parkinson's disease, as well as to treat stroke, brain trauma, and depression has gained increasing interest.
BioFlex is a form of PBMT consisting of light-emitting diodes (LEDs) and laser diodes. BioFlex utilizes red and near infrared light which penetrates tissues up to a certain tissue depth and studies have shown stimulates tissue growth and repair at the cellular level. PBMT has been proven useful for the treatment of soft tissue pain. Several studies have shown benefit in using PBMT in the treatment of certain neurological conditions, including chronic, mild traumatic brain injury (mTBI).
The purpose of this exploratory investigation, therefore, is to examine efficacy of BioFlex laser therapy on measures of brain function in patients suffering from PCS after mild-moderate, closed-head, traumatic brain injury cases.
Exclusion Criteria:
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
Participants will receive 50minutes of PBMT, three times a week, for 8 weeks.
Device: BioFlex Dualport System
Participants will receive 50minutes of Sham PBMT, three times a week, for 8 weeks. The Sham device will appear to function like the treatment device without providing any power intensity (0% power). At 0% power, no light is emitted from the LEDs.
Device: Sham device
The device consists of a laptop computer preprogrammed with the Bioflex® Practitioner+ Software, the Bioflex® DUO 180+ array pad that has 180 bicolour Light Emitting Diodes (LED) that emit red and near infrared light, and two laser probes, the LD-R 100 that emits red light, and the LD-I 200 that emits near infrared light.
Also known as: Photobiomodulation
Control
Response size of selected ERPs (N100, P300, N400) acquired using the NeuroCatch Platform 2
Event-related potentials (ERPs)
Time frame: Visit 1/Baseline to Visit 3/End of Treatment (8 weeks)
Response timing of selected ERPs (N100, P300, N400) acquired using the NeuroCatch Platform 2
Event-related potentials (ERPs)
Time frame: Visit 1/Baseline to Visit 3/End of Treatment (8 weeks)
Number of adverse events
Frequency and severity of adverse events
Time frame: Visit 1/Baseline to Visit 3/End of Treatment (8 weeks)
Number of adverse device effects
Frequency and severity of adverse device effects
Time frame: Visit 1/Baseline to Visit 3/End of Treatment (8 weeks)
Pain Catastrophizing Scale Score
Mean, standard deviation, and assessment of variance. It is a 13-item scale, with a total range of 0 to 52. Higher scores are associated with higher amounts of pain catastrophizing.
Time frame: Visit 1/Baseline to Visit 3/End of Treatment (8 weeks)
Rivermead Post-Concussion Symptoms Questionnaire Score
Mean, standard deviation, and assessment of variance. Scored on a scale of 0-64 where higher scores reflect greater severity of post concussive symptoms.
Time frame: Visit 1/Baseline to Visit 3/End of Treatment (8 weeks)
This study is completed, as verified in May 2024. You cannot join it, but the record below documents what was studied.
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Dr George Medvedev