← Back to Search

Other

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 below

Select...

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

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

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 more

Secondary 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

~50

0 / 2Eligibility criteria met

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

Photobiomodulation Therapy (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05072743 — N/A

Post-Concussion Syndrome Research Study Groups: Post-Concussion Patients with Non-Apneic Sleep Disorder

Post-Concussion Syndrome Clinical Trial 2023: Photobiomodulation Therapy Highlights & Side Effects. Trial Name: NCT05072743 — N/A

Photobiomodulation Therapy (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05072743 — N/A

Frequently Asked Questions

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

Is there an opportunity for me to be involved in this research endeavor?

"This trial is actively seeking 20 individuals aged 18-45 that are clinically diagnosed with Mild Traumatic brain injury (mTBI). To be considered for participation, applicants must have documentation of a mTBI between 3 to 24 months prior and present symptoms consistent with International Classification of Diseases' Post Concussive Syndrome criteria such as headache, dizziness, fatigue, irritability, insomnia or difficulty concentrating/remembering. Additionally a sleep study PSG must have been conducted."

Answered by AI

Does this clinical research include participants aged 55 and above?

"This trial is restricted to individuals aged between 18 and 45. For those below or above this age bracket, there are 51 trials available for younger participants and 134 studies dedicated to the elderly population."

Answered by AI

What is the cap for participants in this experiment?

"Indeed, clinicaltrials.gov reveals that this research is actively recruiting participants since it was first posted on October 20th 2021. The most recent data update occurred on June 1st 2022 and the study requires a total of 20 patients from one medical centre."

Answered by AI

Are there any openings left for participants in this research endeavor?

"Clinicaltrials.gov attests that this medical study is actively enlisting patients, having initially gone live on October 20th 2021 and most recently being updated on June 1st 2022."

Answered by AI

Recent research and studies

Canadian Medical Association JournalJournal

Concussions and Their Consequences: Current Diagnosis, Management and Prevention

Tator, Charles H.. 2013. “Concussions and Their Consequences: Current Diagnosis, Management and Prevention”. Canadian Medical Association Journal. CMA Joule Inc.. doi:10.1503/cmaj.120039.

Psychiatry ResearchJournal

The Pittsburgh Sleep Quality Index: A New Instrument for Psychiatric Practice and Research

Buysse, Daniel J., Charles F. Reynolds III, Timothy H. Monk, Susan R. Berman, and David J. Kupfer. 1989. “The Pittsburgh Sleep Quality Index: A New Instrument for Psychiatric Practice and Research”. Psychiatry Research. Elsevier BV. doi:10.1016/0165-1781(89)90047-4.

Journal of Psychosomatic ResearchJournal

The Multidimensional Fatigue Inventory (MFI) Psychometric Qualities of an Instrument to Assess Fatigue

Smets, E.M.A., B. Garssen, B. Bonke, and J.C.J.M. De Haes. 1995. “The Multidimensional Fatigue Inventory (MFI) Psychometric Qualities of an Instrument to Assess Fatigue”. Journal of Psychosomatic Research. Elsevier BV. doi:10.1016/0022-3999(94)00125-o.

Journal of NeurologyJournal