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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores photobiomodulation therapy (PBMT) to assist individuals with post-concussion syndrome who experience sleep difficulties. The aim is to determine if this light-based therapy can enhance sleep and related brain functions in those with mild traumatic brain injury (mTBI) and sleep problems not caused by sleep apnea. The treatment involves applying special lights to the neck area twice a week for six weeks. Suitable participants have had a concussion in the past 3 to 24 months and continue to experience sleep issues despite treatment. As an unphased trial, this study provides a unique opportunity to investigate innovative treatments that could enhance quality of life.

Do I have to stop taking my current medications for the trial?

Yes, you will need to stop taking any medications that are used to improve sleep, such as cannabis, barbiturates, benzodiazepines, antidepressants, antihistamines, melatonin, or other natural supplements. You also cannot take any photosensitizing medications.

What prior data suggests that Photobiomodulation Therapy is safe for post-concussion patients with non-apneic sleep disorder?

Research has shown that photobiomodulation therapy (PBMT) is generally safe. This treatment uses specific types of red and near-infrared light and has been applied to patients with brain injuries, with few reports of serious side effects.

In one study, patients who received this light therapy soon after a brain injury demonstrated positive changes in brain activity without major side effects. Another study examined PBMT for brain injuries and found it to be a safe option.

While specific side effects are not always detailed, the lack of serious negative reports is promising. This suggests that PBMT could be a safe treatment for those considering clinical trials for post-concussion symptoms. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Photobiomodulation Therapy (PBMT) is unique because it uses light to target post-concussion symptoms, specifically non-apneic sleep disorders, by applying LED and laser light to the cervical spine. This approach contrasts with traditional treatments like medication and cognitive therapy, offering a non-invasive option. Researchers are excited because PBMT uses red and near-infrared light at specific wavelengths, which may promote healing and reduce inflammation in soft tissue injuries. This innovative method has the potential to provide relief and improve quality of life for patients with fewer side effects.

What evidence suggests that Photobiomodulation Therapy might be an effective treatment for post-concussion syndrome?

Research has shown that photobiomodulation therapy (PBMT) can alleviate symptoms in people with post-concussion syndrome. In this trial, participants with post-concussion syndrome and non-apneic sleep disorder will receive PBMT using the BIOFLEX® DUO+ system. Studies have found that patients who received PBMT experienced noticeable improvements in cognitive skills and sleep issues. For instance, one study reported that all patients improved and performed better on tests after treatment. Animal studies also support these findings, demonstrating enhanced brain recovery after similar light therapy. PBMT uses light to aid healing and improve brain function, offering a promising option for those with sleep issues following a concussion. ^{2 6 7 8 9}

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

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 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?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5379852/

Transcranial low level laser (light) therapy for traumatic ... We review the use of transcranial low-level laser (light) therapy (LLLT) as a possible treatment for traumatic-brain injury (TBI).

2. fortunejournals.com fortunejournals.com/articles/impact3b-assessment-of-photobiomodulation-therapy-for-postconcussion-syndrome.html

ImPACT® Assessment of Photobiomodulation Therapy for ... Results: All patients improved clinically after PBMT and their Post injury 2 ImPACT® test results were significantly better compared to their Post injury 1 ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4043367/

Significant Improvements in Cognitive Performance Post ... Multiple animal studies using mice, show significantly better recovery of motor and cognitive function after NIR transcranial low-level laser therapy when ...

4. concussionalliance.org concussionalliance.org/light-therapy-photobiomodulation

Light therapy for concussions, repetitive head impacts A series of case studies and small clinical trials have shown light therapy to be helpful for persistent post-concussion symptoms.

5. researchgate.net researchgate.net/publication/357740981_ImPACTR_Assessment_of_Photobiomodulation_Therapy_for_Post-Concussion_Syndrome

(PDF) ImPACT® Assessment of Photobiomodulation ... This study uses ImPACT® as a means to document an improvement in symptomatology for patients with persistent post-concussion symptoms pre and ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT05097222

Impact of Photobiomodulation on Objective, Physiological ... A phase of research to describe clinical trials that focus on the safety of a drug. They are usually conducted with healthy volunteers, and the goal is to ...

7. pubs.rsna.org pubs.rsna.org/doi/full/10.1148/radiol.230999

Effects of Low-Level Light Therapy on Resting-State ... Patients with moderate traumatic brain injury who were administered low-level light therapy within 72 hours after injury showed increased resting-state brain ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10931349/

Traumatic Brain Injury Recovery with Photobiomodulation The objective of this study is to analyze transcranial photobiomodulation (PBM), which employs specific red to near-infrared light wavelengths ...

9. clinicaltrials.gov clinicaltrials.gov/study/NCT04823507

NCT04823507 | Photobiomodulation for Concussions: the ... Our emphasis on this study is to review the use of PBM as a treatment modality for concussions and the use of ImPACT® (Immediate Post-Concussion Assessment and ...