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

Primary Purpose

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

Status

Recruiting

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

BioFlex Dualport System

Sham device

About this trial

This is an interventional treatment trial for Post-Concussive Syndrome, Chronic

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

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), 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:

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

Sites / Locations

Center for Neurology StudiesRecruiting
Meditech Rehabilitation CentreRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Active PBMT

Sham PBMT

Arm Description

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

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.

Outcomes

Primary Outcome Measures

Response size of selected ERPs (N100, P300, N400) acquired using the NeuroCatch Platform 2

Event-related potentials (ERPs)

Response timing of selected ERPs (N100, P300, N400) acquired using the NeuroCatch Platform 2

Event-related potentials (ERPs)

Secondary Outcome Measures

Number of adverse events

Frequency and severity of adverse events

Number of adverse device effects

Frequency and severity of adverse device effects

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.

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.

Full Information

NCT ID

NCT05097222

First Posted

October 15, 2021

Last Updated

September 20, 2023

Sponsor

Dr George Medvedev

Collaborators

MediTech International Inc.

1. Study Identification

Unique Protocol Identification Number

NCT05097222

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Recruiting

Study Start Date

January 27, 2022 (Actual)

Primary Completion Date

June 27, 2024 (Anticipated)

Study Completion Date

December 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Dr George Medvedev

Collaborators

MediTech International Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Masking Description

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.

Allocation

Randomized

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Active PBMT

Arm Type

Experimental

Arm Description

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

Arm Title

Sham PBMT

Arm Type

Sham Comparator

Arm Description

Intervention Type

Device

Intervention Name(s)

BioFlex Dualport System

Other Intervention Name(s)

Photobiomodulation

Intervention Description

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.

Intervention Type

Device

Intervention Name(s)

Sham device

Intervention Description

Control

Primary Outcome Measure Information:

Title

Response size of selected ERPs (N100, P300, N400) acquired using the NeuroCatch Platform 2

Description

Event-related potentials (ERPs)

Time Frame

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

Title

Response timing of selected ERPs (N100, P300, N400) acquired using the NeuroCatch Platform 2

Description

Event-related potentials (ERPs)

Time Frame

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

Secondary Outcome Measure Information:

Title

Number of adverse events

Description

Frequency and severity of adverse events

Time Frame

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

Title

Number of adverse device effects

Description

Frequency and severity of adverse device effects

Time Frame

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

Title

Pain Catastrophizing Scale Score

Description

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)

Title

Rivermead Post-Concussion Symptoms Questionnaire Score

Description

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)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

19 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. 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), 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: 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Natasha Campbell

Phone

778-874-7758

natashacampbell@healthtechconnex.com

Facility Information:

Facility Name

Center for Neurology Studies

City

Surrey

State/Province

British Columbia

ZIP/Postal Code

V3V 0C6

Country

Canada

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Natasha Campbell

Phone

778-874-7758

natashacampbell@healthtechconnex.com

First Name & Middle Initial & Last Name & Degree

George Medvedev, MD

Facility Name

Meditech Rehabilitation Centre

City

Etobicoke

State/Province

Ontario

ZIP/Postal Code

M8W 4W3

Country

Canada

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Ronald Santiago

Phone

1-888-557-4004

ronaldo@bioflexlaser.com

First Name & Middle Initial & Last Name & Degree

Michael Zitney, MD

12. IPD Sharing Statement

Learn more about this trial

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

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