Photobiomodulation for Post-Concussion Syndrome

Overseen By Celeste Thirlwell, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Michael Zitney

Must not be taking: Cannabis, Barbiturates, Benzodiazepines, others

Disqualifiers: Severe anxiety, Severe depression, Schizophrenia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 15

Duration: 6 weeks

20 Participants Needed

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Photobiomodulation Therapy (PBMT) using the BIOFLEX® DUO+ system twice per week for 6 weeks

6 weeks

12 visits (in-person)

Follow-up

Participants are monitored for changes in sleep and neurocognitive function using various questionnaires and polysomnography

6 weeks

3 visits (in-person)

Treatment Details

Interventions

• Photobiomodulation Therapy

Trial Overview 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.

Participant Groups

Group I: Post-Concussion Patients with Non-Apneic Sleep Disorder Experimental Treatment 1 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 United States, European Union, Canada for the following indications:

Approved in United States as Photobiomodulation Therapy for:

• Pain relief
• Tissue repair
• Inflammation reduction
• Wound healing

Approved in European Union as Photobiomodulation Therapy for:

• Pain relief
• Tissue repair
• Inflammation reduction
• Wound healing

Approved in Canada as Photobiomodulation Therapy for:

• Pain relief
• Tissue repair
• Inflammation reduction
• Wound healing

Who Is Running the Clinical Trial?

Michael Zitney

Lead Sponsor

Trials

1

Recruited

20+

Meditech Rehabilitation Centre

Collaborator

Trials

2

Recruited

60+