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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 4 weeks, 8 weeks, 12 weeks
Awards & highlights
Study Summary
This trial is testing if PBMT can help improve sleep and thinking problems in people with TBIs who don't have sleep apnea.
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.Check my eligibility
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.See study design
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 belowSelect...
I had a mild brain injury 3-24 months ago and still have symptoms like headaches or memory issues.
Select...
I am 18-70 years old with a mild brain injury diagnosed 3-24 months ago and have trouble sleeping.
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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 moreSecondary outcome measures
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 outcome measures
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
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
~70
Find a Location
Who is running the clinical trial?
Michael ZitneyLead Sponsor
Meditech Rehabilitation CentreOTHER
1 Previous Clinical Trials
35 Total Patients Enrolled
Alan Lowe, MDPrincipal InvestigatorMeditech International
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have other health issues in addition to a mild traumatic brain injury.Any signs of problems in the brain found on imaging tests.I am taking medication or supplements to help me sleep.I have been diagnosed with severe anxiety, depression, schizophrenia, or bipolar disorder.I had a sleep study in the last year showing I have a sleep disorder with new or worsening symptoms.I am currently using alternative or complementary medical treatments.My family has a history of mental health conditions.I had a mild brain injury 3-24 months ago and still have symptoms like headaches or memory issues.I am currently receiving cognitive behavioral therapy.I am 18-70 years old with a mild brain injury diagnosed 3-24 months ago and have trouble sleeping.I have a cancerous growth in my head or neck.I am not taking any medication that increases my sensitivity to sunlight.
Research Study Groups:
This trial has the following groups:- Group 1: Post-Concussion Patients with Non-Apneic Sleep Disorder
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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