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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Post-Concussion Syndrome; Mild Traumatic Brain Injury; Post-Concussive Syndrome, Chronic
• Intervention / Treatment: Device: BioFlex Dualport System; Device: Sham device

• Study Type: Interventional
• Enrollment (Actual): 19
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Natasha Campbell; Phone Number: 778-874-7758; Email: natashacampbell@healthtechconnex.com

Study Locations

• Canada
  • British Columbia
    • Surrey, British Columbia, Canada, V3V 0C6
      • Center for Neurology Studies
  • Ontario
    • Etobicoke, Ontario, Canada, M8W 4W3
      • Meditech Rehabilitation Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Male or female, at least 19 years of age or older
2. 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.
3. Current pharmacologic management can remain stable throughout the protocol.
4. Fluent in English
5. Able to understand the informed consent form, study procedures and willing to participate in study.

Exclusion Criteria:

1. Malignant skin carcinoma within the treatment area (neck and cranium)
2. Intake of photosensitizing medication.
3. Prior history of PBMT therapy
4. 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
5. History of other major neurological disorder (brain cancer, dementia, multiple sclerosis, stroke)
6. Diagnosed epilepsy or history of seizures not effectively controlled by medications
7. 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
8. Pregnant, suspected to be pregnant or planning to become pregnant during the study
9. 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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Active PBMT; Participants will receive 50minutes of PBMT, three times a week, for 8 weeks.	Device: BioFlex Dualport System; 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.; Other Names: Photobiomodulation
Sham Comparator: Sham PBMT; 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; Control

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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)

Secondary Outcome Measures

Outcome Measure	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	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)

Collaborators and Investigators

• Sponsor: Dr George Medvedev
• Collaborators: MediTech International Inc.

Study record dates

Study Major Dates

• Study Start (Actual): January 27, 2022
• Primary Completion (Actual): January 27, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: October 15, 2021
• First Submitted That Met QC Criteria: October 15, 2021
• First Posted (Actual): October 28, 2021

Study Record Updates

• Last Update Posted (Actual): March 12, 2024
• Last Update Submitted That Met QC Criteria: March 8, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Disease; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds, Nonpenetrating; Syndrome; Brain Injuries; Brain Injuries, Traumatic; Post-Concussion Syndrome; Brain Concussion
• Other Study ID Numbers: BioFlex_PCS_001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No