What side effects are associated with this type of intervention?

Common treatments for Post-Concussion Syndrome (PCS) include cognitive and physical rest, medications for symptom management, and various forms of therapy such as physical therapy and cognitive behavioral therapy. Side effects of these treatments can vary. Medications like NSAIDs may cause gastrointestinal issues or rebound headaches if used excessively. Cognitive and physical rest generally have no side effects but may lead to temporary inactivity-related issues. For treatments similar to BioFlex Photobiomodulation Therapy, such as light therapy, side effects are minimal but can include mild headaches, eye strain, or sleep disturbances. Overall, these therapies are considered safe with low risk of adverse effects.

What prior FDA approvals exist?

There are no specific FDA-approved drugs mentioned in the context for the treatment of Post-Concussion Syndrome (PCS) that align directly with the mechanisms of BioFlex Photobiomodulation Therapy (PBMT). PBMT itself is noted for its potential benefits in enhancing neuronal metabolic capacity, and stimulating anti-inflammatory, anti-apoptotic, and antioxidant responses, as well as promoting neurogenesis and synaptogenesis. While PBMT shows promise in treating neurological conditions, including PCS, further studies and FDA approvals are needed to establish its efficacy and safety for this specific use.

What other types of research exist?

One promising alternative to BioFlex PBMT for PCS patients is the use of human bone marrow stromal cell (hBMSC) transplantation combined with basic fibroblast growth factor (bFGF). This combination has been shown to enhance neural tissue regeneration, reduce infarction volume and apoptotic activity, and significantly improve functional outcomes. Another potential alternative is the intravenous infusion of human bone marrow mesenchymal stromal cells (hBM-MSC), which has demonstrated functional recovery and neuroplasticity after ischemic stroke, suggesting potential benefits for PCS patients.

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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

Must not have

History of other major neurological disorder (brain cancer, dementia, multiple sclerosis, stroke)

Diagnosed epilepsy or history of seizures not effectively controlled by medications

Timeline

Screening 3 weeks

Treatment Varies

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

Summary

This trial is testing BioFlex laser therapy, which uses special light to help brain cells recover, on patients with post-concussion syndrome after a mild to moderate head injury. The light therapy aims to improve brain function by boosting cell energy, reducing inflammation, and promoting cell growth. Preclinical studies have shown that this light therapy administered after head injury confers a neuroprotective response.

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.

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.

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

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have no history of major neurological disorders like brain cancer or dementia.

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My epilepsy or seizures are not well-controlled by medication.

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I am taking medication that increases my sensitivity to light.

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I have skin cancer on my head or neck.

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I have severe anxiety, depression, schizophrenia, or bipolar disorder.

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I have previously undergone PBMT therapy.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

BioFlex Dualport System

2022

N/A

~20

0 / 7Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Post-Concussion Syndrome (PCS) that share mechanisms with BioFlex Photobiomodulation Therapy (PBMT) include therapies that enhance neuronal metabolism, reduce inflammation, prevent cell death, and promote neurogenesis and synaptogenesis. PBMT, for instance, increases the metabolic capacity of neurons, stimulates anti-inflammatory, anti-apoptotic, and antioxidant responses, and encourages the growth of new neurons and synaptic connections. These mechanisms are vital for PCS patients as they address the cellular and molecular dysfunctions caused by brain injury, supporting energy production, reducing oxidative stress and inflammation, preventing cell death, and aiding cognitive and functional recovery. This comprehensive approach can significantly improve the quality of life for PCS patients by targeting the root causes of their symptoms.

Photobiomodulation therapy improved functional recovery and overexpression of interleukins-10 after contusion spinal cord injury in rats.Effect of photobiomodulation treatment in the sublingual, radial artery region, and along the spinal column in individuals with multiple sclerosis: Protocol for a randomized, controlled, double-blind, clinical trial.Investigational agents for treatment of traumatic brain injury.