Photobiomodulation for Post-Concussion Syndrome

Recruiting in Palo Alto (17 mi)

Overseen byMichael Zitney, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Michael Zitney

No Placebo Group

Approved in 3 Jurisdictions

Trial Summary

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.

Research Team

Alan Lowe, MD

Principal Investigator

Meditech International

Michael Zitney, MD

Principal Investigator

MediTech International Inc.

Eligibility Criteria

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

I had a sleep study in the last year showing I have a sleep disorder with new or worsening symptoms.

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

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

Exclusion 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.

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Treatment Details

Interventions

Photobiomodulation Therapy (Other)

Trial OverviewThe 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.

Participant Groups

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.

Photobiomodulation Therapy is already approved in Canada for the following indications: