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Photobiomodulation for Post-Concussion Syndrome

N/A

Recruiting

Led By Alan Lowe, MD

Research Sponsored by Michael Zitney

Eligibility Criteria Checklist

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

Must have

Documentation of a history of a qualifying mTBI within 3 to 24 months of traumatic incident and/or diagnosis with persistent symptomatology after 3 months. For reference, International Classification of Diseases, Tenth Revision (ICD-10) clinical criteria for Post Concussive Syndrome (PCS) 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

Patients between the ages of 18-70 years clinically diagnosed with a mTBI diagnosed between 3 to 24 months from presentation complaining of sleep disturbance

Must not have

Any additional diagnoses compounding the diagnosis of a mTBI

Currently taking any medication for the purpose of improving sleep including medical and recreational cannabis, barbiturates, benzodiazepines, antidepressants, antihistamines, melatonin or other natural supplements

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 4 weeks, 8 weeks, 12 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial is investigating the use of light therapy to help people who have had a mild brain injury and are struggling with sleep problems not caused by sleep apnea. The therapy aims to improve their sleep and mental functions by stimulating brain activity with light. This approach is being tested because these patients often do not get better with other treatments. Light therapy is emerging as a potential treatment for improving sleep and physiological functions, though research on its full-body applications is still limited.

Who is the study for?

This trial is for adults aged 18-70 with mild traumatic brain injury (mTBI) diagnosed within the last 3 to 24 months, experiencing sleep disturbances not due to sleep apnea. Participants must have had a recent sleep study and cannot be on any medication or alternative treatments for sleep, nor can they have positive cranial imaging findings or severe neuropsychiatric conditions.

What is being tested?

The trial is testing Photobiomodulation Therapy (PBMT) as a treatment to improve both sleep issues and related cognitive functions in patients who've had mTBI. It aims to see if PBMT can help those whose symptoms persist despite other treatments.

What are the potential side effects?

While specific side effects of PBMT are not detailed here, common ones may include headache, fatigue, irritability from light exposure. However, since it's non-invasive and doesn't involve drugs, fewer side effects are expected compared to pharmacological treatments.

Eligibility Criteria

Inclusion Criteria

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

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I had a mild brain injury 3-24 months ago and still have symptoms like headaches or memory issues.

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I am 18-70 years old with a mild brain injury diagnosed 3-24 months ago and have trouble sleeping.

Exclusion Criteria

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

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I have other health issues in addition to a mild traumatic brain injury.

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I am taking medication or supplements to help me sleep.

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I have been diagnosed with severe anxiety, depression, schizophrenia, or bipolar disorder.

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I am currently receiving cognitive behavioral therapy.

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I have a cancerous growth in my head or neck.

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I am not taking any medication that increases my sensitivity to sunlight.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 4 weeks, 8 weeks, 12 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 4 weeks, 8 weeks, 12 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 4 weeks, 8 weeks, 12 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

Statistically significant changes in the Epsworth Sleepiness Scale (ESS) scores from baseline and at 12 weeks

Statistically significant changes in the Epsworth Sleepiness Scale (ESS) scores from baseline and at 4 weeks

Statistically significant changes in the Epsworth Sleepiness Scale (ESS) scores from baseline and at 8 weeks

+5 more

Secondary study objectives

Statistically significant changes in the Functional Outcomes of Sleep Questionnaire (short version) (FOSQ-10) scores from baseline

Statistically significant changes in the Motivation and Energy Inventory Short Form (MEI-SF) scores from baseline

Statistically significant changes in the Rivermead Post-Concussion Symptoms Questionnaire (RPQ) scores from baseline

Other study objectives

Any potential changes in Stage 3 Non Rapid Eye Movement (NREM) or N3 sleep duration (time in minutes) during Type 1 overnight Polysomnography (OSG) from Baseline and at 8 weeks.

Any potential changes in Stage 4 Rapid Eye Movement (REM) sleep duration (time in minutes) during Type 1 overnight Polysomnography (OSG) from Baseline and at 8 weeks

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Post-Concussion Patients with Non-Apneic Sleep DisorderExperimental Treatment1 Intervention

Patients will be treated with PBMT using the BIOFLEX® DUO+ system that utilizes a Light Emitting Diode (LED) array pad followed by laser probes. Both delivery methods will be applied to the cervical spine and will entail the use of red light at 660 nm wavelength and near-infrared light at 830-840 nm wavelength. Treatment is provided twice per week for 6 weeks for a total of 12 treatments utilizing Health Canada approved device specific protocol guidelines for the treatment of the cervical spine soft tissue injuries.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Photobiomodulation Therapy

2023

Completed Phase 2

~180

0 / 8Eligibility criteria met