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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
Sponsored by
Dr George Medvedev
About
Eligibility
Locations
Arms
Outcomes
Full info

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:

  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

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

First Posted
October 15, 2021
Last Updated
September 20, 2023
Sponsor
Dr George Medvedev
Collaborators
MediTech International Inc.
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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
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

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
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.
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
No
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
Email
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
Email
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
Email
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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