Impact of Photobiomodulation on Objective, Physiological Measures of Brain Function in Individuals With Post-Concussion Syndrome

NCT05097222 | Completed

• 1 other identifier: BioFlex_PCS_001
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Post-Concussive Syndrome, Chronic; Post-Concussion Syndrome; Mild Traumatic Brain Injury

Outcome Measures

Primary Outcomes (2)

• 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)

Secondary Outcomes (4)

• Number of adverse events

  Visit 1/Baseline to Visit 3/End of Treatment (8 weeks)

• Number of adverse device effects

  Visit 1/Baseline to Visit 3/End of Treatment (8 weeks)

• Pain Catastrophizing Scale Score

  Visit 1/Baseline to Visit 3/End of Treatment (8 weeks)

• Rivermead Post-Concussion Symptoms Questionnaire Score

  Visit 1/Baseline to Visit 3/End of Treatment (8 weeks)

Study Arms (2)

Active PBMT

EXPERIMENTAL

Participants will receive 50minutes of PBMT, three times a week, for 8 weeks.

Device: BioFlex Dualport System

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.

Device: Sham device

Interventions

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.

Also known as: Photobiomodulation

Active PBMT

Sham device DEVICE

Control

Sham PBMT

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female, at least 19 years of age or older
• Diagnosis of persistent post-concussional syndrome after ≥3 months of traumatic brain injury, based on the ICD-10 criteria. This diagnosis should be given to the patient from a clinical practitioner. ICD-10 clinical criteria require a history of TBI and the presence of three or more of the following eight symptoms: 1) headache, 2) 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 to participate in study.

You may not qualify if:

• 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), severe depression (or score of ≥20 on the PHQ-9), schizophrenia or bipolar disorder
• History of other major neurological disorder (brain cancer, dementia, multiple sclerosis, 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, or concurrent 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:
• 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

Sponsors & Collaborators

• Dr George Medvedev: lead
• MediTech International Inc.: collaborator

Study Sites (2)

Center for Neurology Studies

Surrey, British Columbia, V3V 0C6, Canada

Location

Meditech Rehabilitation Centre

Etobicoke, Ontario, M8W 4W3, Canada

Location

MeSH Terms

Conditions

Post-Concussion Syndrome; Brain Concussion

Interventions

Low-Level Light Therapy

Condition Hierarchy (Ancestors)

Head Injuries, Closed; Craniocerebral Trauma; Trauma, Nervous System; Nervous System Diseases; Wounds and Injuries; Wounds, Nonpenetrating; Brain Injuries, Traumatic; Brain Injuries; Brain Diseases; Central Nervous System Diseases

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Sponsor-Investigator

Study Record Dates

• First Submitted: October 15, 2021
• First Posted: October 28, 2021
• Study Start: January 27, 2022
• Primary Completion: December 13, 2023
• Study Completion: December 13, 2023
• Last Updated: May 29, 2024

Record last verified: 2024-05

Locations

CA (2)