Photobiomodulation for Post-Concussion Syndrome
What You Need to Know Before You Apply
What is the purpose of this trial?
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 on the Research Team?
Alan Lowe, MD
Principal Investigator
Meditech International
Michael Zitney, MD
Principal Investigator
MediTech International Inc.
Are You a Good Fit for This Trial?
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.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive Photobiomodulation Therapy (PBMT) using the BIOFLEX® DUO+ system twice per week for 6 weeks
Follow-up
Participants are monitored for changes in sleep and neurocognitive function using various questionnaires and polysomnography
What Are the Treatments Tested in This Trial?
Interventions
- Photobiomodulation Therapy
Photobiomodulation Therapy is already approved in United States, European Union, Canada for the following indications:
Find a Clinic Near You
Who Is Running the Clinical Trial?
Michael Zitney
Lead Sponsor
Meditech Rehabilitation Centre
Collaborator