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| Name | Class |
|---|---|
| MediTech International Inc. | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active PBMT | Experimental | Participants will receive 50minutes of PBMT, three times a week, for 8 weeks. |
|
| Sham PBMT | Sham Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BioFlex Dualport System | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Response size of selected ERPs (N100, P300, N400) acquired using the NeuroCatch Platform 2 | Event-related potentials (ERPs) | 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) | Visit 1/Baseline to Visit 3/End of Treatment (8 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of adverse events | Frequency and severity of adverse events | Visit 1/Baseline to Visit 3/End of Treatment (8 weeks) |
| Number of adverse device effects | Frequency and severity of adverse device effects |
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Inclusion Criteria:
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
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for Neurology Studies | Surrey | British Columbia | V3V 0C6 | Canada | ||
| Meditech Rehabilitation Centre |
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Study participants will be blinded to the PBMT treatment regimen they will receive. Participants will wear opaque goggles to blind them from seeing any light emitted from the LED arrays.
A trained laser technician will provide treatment to the study participants. The laser clinician will be unblinded to the participant's treatment allocation. Assessments will be performed by an independent blinded assessor.
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| Sham device | Device | Control |
|
| 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. | 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. | Visit 1/Baseline to Visit 3/End of Treatment (8 weeks) |
| Etobicoke |
| Ontario |
| M8W 4W3 |
| Canada |
| ID | Term |
|---|---|
| D038223 | Post-Concussion Syndrome |
| D001924 | Brain Concussion |
| ID | Term |
|---|---|
| D016489 | Head Injuries, Closed |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D009422 | Nervous System Diseases |
| D014947 | Wounds and Injuries |
| D014949 | Wounds, Nonpenetrating |
| D000070642 | Brain Injuries, Traumatic |
| D001930 | Brain Injuries |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D028022 | Low-Level Light Therapy |
| ID | Term |
|---|---|
| D053685 | Laser Therapy |
| D013812 | Therapeutics |
| D010789 | Phototherapy |
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