20 Participants Needed

Photobiomodulation for Post-Concussion Syndrome

RS
CT
Overseen ByCeleste Thirlwell, MD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 3 JurisdictionsThis treatment is already approved in other countries

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?

AL

Alan Lowe, MD

Principal Investigator

Meditech International

MZ

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

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.
See 7 more

Timeline for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Post-Concussion Patients with Non-Apneic Sleep DisorderExperimental Treatment1 Intervention

Photobiomodulation Therapy is already approved in United States, European Union, Canada for the following indications:

🇺🇸
Approved in United States as Photobiomodulation Therapy for:
🇪🇺
Approved in European Union as Photobiomodulation Therapy for:
🇨🇦
Approved in Canada as Photobiomodulation Therapy for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

Michael Zitney

Lead Sponsor

Trials
1
Recruited
20+

Meditech Rehabilitation Centre

Collaborator

Trials
2
Recruited
60+
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