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

Mild Traumatic Brain Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05097222
• Other study ID #: BioFlex_PCS_001
• Status: Completed
• Phase: N/A
• Start date: January 27, 2022
• Est. completion date: December 13, 2023

Study information

• Verified date: May 2024
• Source: HealthTech Connex Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: December 13, 2023
• Est. primary completion date: December 13, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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.
• Sham device
Control

Locations

Country	Name	City	State
Canada	Meditech Rehabilitation Centre	Etobicoke	Ontario
Canada	Center for Neurology Studies	Surrey	British Columbia

Sponsors (2)

Lead Sponsor	Collaborator
Dr George Medvedev	MediTech International Inc.

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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	Number of adverse events	Frequency and severity of adverse events	Visit 1/Baseline to Visit 3/End of Treatment (8 weeks)
Secondary	Number of adverse device effects	Frequency and severity of adverse device effects	Visit 1/Baseline to Visit 3/End of Treatment (8 weeks)
Secondary	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)
Secondary	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)