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Photobiomodulation

Light Therapy for Post-Concussion Syndrome

N/A

Waitlist Available

Research Sponsored by Dr George Medvedev

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up visit 1/baseline to visit 3/end of treatment (8 weeks)

Awards & highlights

Study Summary

This trial is testing whether light therapy can help improve symptoms for people who have post-concussion syndrome after a mild to moderate brain injury.

Who is the study for?

This trial is for adults over 19 with persistent post-concussion syndrome from a traumatic brain injury that occurred at least 3 months ago. Participants must be fluent in English, able to consent, and on stable medication. Excluded are those with skin cancer in the treatment area, taking photosensitizing meds, prior PBMT therapy, severe mental health issues, major neurological disorders, uncontrolled seizures, recent investigational drug/device use or pregnancy.Check my eligibility

What is being tested?

The study tests BioFlex laser therapy's effectiveness on brain function in patients with post-concussion syndrome (PCS). It uses red and near-infrared light to stimulate cellular repair. A sham device serves as a control to compare results against the actual BioFlex treatment.See study design

What are the potential side effects?

While specific side effects of PBMT like BioFlex aren't detailed here, common concerns may include discomfort at the application site or temporary visual disturbances due to bright lights used during therapy.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have been diagnosed with long-term symptoms after a head injury.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ visit 1/baseline to visit 3/end of treatment (8 weeks)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~visit 1/baseline to visit 3/end of treatment (8 weeks)

This trial's timeline: 3 weeks for screening, Varies for treatment, and visit 1/baseline to visit 3/end of treatment (8 weeks) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

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

Secondary outcome measures

Number of adverse device effects

Number of adverse events

Pain Catastrophizing Scale Score

+1 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Active PBMTExperimental Treatment1 Intervention

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

Group II: Sham PBMTPlacebo Group1 Intervention

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.

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Dr George MedvedevLead Sponsor

MediTech International Inc.UNKNOWN

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the current roster for participants in this medical trial?

"Affirmative, the clinical trial is indeed recruiting. According to records hosted on clinicaltrials.gov, it was posted on January 27th 2022 and most recently edited on August 8th 2022 with a recruitment goal of 20 people at 2 different sites."

Answered by AI

Is recruitment for this project ongoing?

"Absolutely. The clinical trial website indicates that this research initiative, which was published on January 27th 2022, is actively recruiting participants. At the moment, there are 20 openings across two different sites."

Answered by AI

What are the chief aims of this experiment?

"This medical trial has two primary goals. Firstly, to assess the response timing of ERPs (N100, P300 and N400) gathered from NeuroCatch Platform 2 over an 8-week period. Secondly, researchers are looking at Rivermead Post Concussion Symptoms Questionnaire Score (ranging 0-64), Pain Catastrophizing Scale Score (0-52) and Number of Adverse Device Effects for secondary outcomes."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Dr George Medvedev 2022. "Impact of Photobiomodulation on Objective, Physiological Measures of Brain Function in Individuals With Post-Concussion Syndrome". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05097222.

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