Photobiomodulation Therapy for Sports Concussion

Overseen By Summer Ott, PsyD

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: The University of Texas Health Science Center, Houston

Must not be taking: Benzodiazepines, Anticonvulsants, Mood stabilizers, others

Disqualifiers: Epilepsy, Schizophrenia, Bipolar, others

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

Compensation: Varies

Number of Visits: 5

Duration: 4 weeks

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new light therapy called Photobiomodulation Therapy (PBMt) to determine if it aids athletes in recovering from sports-related concussions more effectively than standard treatments. The researchers aim to assess how this therapy affects brain connections and how these changes relate to psychological and behavioral outcomes. Participants should be athletes recently diagnosed with a concussion and at risk for longer recovery times. As an unphased trial, this study provides athletes the opportunity to explore innovative recovery options beyond standard treatments.

Will I have to stop taking my current medications?

Yes, you will need to stop taking certain medications like benzodiazepines, anti-convulsants, mood stabilizers, stimulants, opioids, sleep aids, or other neuropsychiatric medications to participate in this trial.

What prior data suggests that Photobiomodulation therapy (PBMt) is safe for treating sports concussions?

Research has shown that photobiomodulation therapy (PBMt), which uses red or near-infrared light to aid tissue healing, has been studied for brain injuries like concussions. Studies have found that PBMt can aid recovery after mild brain injuries by protecting brain cells and improving mitochondrial function, the energy producers in cells.

Regarding safety, research suggests that PBMt is generally well-tolerated. Studies involving brain injuries have reported no major side effects. This indicates that PBMt might be a safe option for treating sports-related concussions. However, it is important to consult healthcare providers before joining clinical trials, as individual responses can vary. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Photobiomodulation therapy (PBMt) is unique because it uses light to stimulate the body's natural healing processes, which is different from the usual medications or therapies for sports concussions that often focus on symptom management. Unlike standard treatments, which might involve rest and medication to alleviate symptoms like headaches and dizziness, PBMt directly targets cellular function to promote recovery. Researchers are excited about this therapy because it has the potential to speed up recovery times and improve outcomes by enhancing brain function at the cellular level, offering a new approach to managing concussions.

What evidence suggests that Photobiomodulation therapy might be an effective treatment for sports concussion?

Research has shown that Photobiomodulation therapy (PBMt), which participants in this trial may receive, might help with brain injuries like concussions. One study found that PBMt improved recovery, enabling people to do more after a mild brain injury. It also helped reduce signs of brain cell damage. Another study demonstrated that PBMt could ease symptoms for those with long-term post-concussion problems. These findings suggest that PBMt could be a promising option for recovery after a sports concussion. ^{1 3 4 5 6}

Who Is on the Research Team?

Summer Ott, PsyD

Principal Investigator

The University of Texas Health Science Center, Houston

Are You a Good Fit for This Trial?

This trial is for adolescent athletes who are experiencing a slow recovery from recent sports-related concussions. Participants must be in the subacute phase of concussion, meaning they're past the initial injury but still have symptoms. They should not yet have received any other treatment for their concussion.

Inclusion Criteria

Considered at-risk for protracted recovery based on Immediate Post-concussion Assessment and Cognitive Testing (ImPACT) performance and symptom reporting on the Post-Concussion Symptom Scale (PCSS)

Current participants in a school- or club-sponsored sport (contact or non-contact)

I was diagnosed with a sports-related concussion by a doctor 3-7 days ago.

Exclusion Criteria

I have a serious injury in addition to my brain injury.

Substance dependence

I do not have conditions like epilepsy, schizophrenia, or a history of severe brain injury.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive Photobiomodulation therapy (PBMt) or standard care for concussion recovery

4 weeks

3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Photobiomodulation therapy (PBMt)

Trial Overview The study is testing Photobiomodulation therapy (PBMt), which uses light to promote healing, against the standard care given for concussions. The goal is to see if PBMt can speed up recovery. Researchers will also use advanced MRI scans to look at how the brain's connections change over time with this treatment.

How Is the Trial Designed?

Group I: Treatment: Photobiomodulation therapy (PBMt) Experimental Treatment 2 Interventions

Group II: Control Active Control 1 Intervention

Who Is Running the Clinical Trial?

The University of Texas Health Science Center, Houston

Lead Sponsor

Trials

974

Recruited

361,000+

TIRR Foundation Mission Connect

Collaborator

Trials

1

Recruited

30+

TIRR/Mission Connect

Collaborator

Trials

3

Recruited

310+

Published Research Related to This Trial

Photobiomodulation therapy (PBMT), also known as low-level laser therapy, has been effectively used for over 30 years to treat neurological diseases, utilizing low-powered lasers and increasingly, LEDs.

The therapy works by absorbing photons in cellular structures, which influences oxidative states and affects the expression of proteins related to oxidative stress, inflammation, pain, and neuronal growth, highlighting its potential mechanisms of action.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mechanistic aspects of photobiomodulation therapy in the nervous system. Ramezani, F., Neshasteh-Riz, A., Ghadaksaz, A., et al.[2022]

Photobiomodulation therapy combined with static magnetic fields (PBMT-sMF) significantly improves muscle strength and reduces muscle damage markers when applied 5 minutes to 6 hours before exercise, with effects lasting up to 54 hours post-treatment.

The study, involving 60 healthy male participants in a randomized, triple-blinded trial, found that longer pre-exercise intervals (like 1 day) diminished the benefits of PBMT-sMF, indicating that timing is crucial for optimal efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

What is the optimal time-response window for the use of photobiomodulation therapy combined with static magnetic field (PBMT-sMF) for the improvement of exercise performance and recovery, and for how long the effects last? A randomized, triple-blinded, placebo-controlled trial. Leal-Junior, ECP., de Oliveira, MFD., Joensen, J., et al.[2022]

Photobiomodulation therapy is considered a safe treatment option that can influence inflammatory and immune responses.

This therapy not only helps in modulating these responses but also promotes metabolic processes that aid in the regeneration of damaged tissues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Laser oromaxillofacial photobiomodulation therapy: molecular mechanisms, outcomes and considerations. Fiani, B., Jarrah, R., Nathani, KR.[2022]

Low-level laser therapy (LLLT) shows promise as a treatment for traumatic brain injury (TBI) by promoting neurogenesis, reducing inflammation, and providing neuroprotection, as supported by both animal and clinical trials.

In studies conducted on mice, the most effective treatment involved pulsed laser irradiation at 10 Hz and specific wavelengths of 660 and 810 nm, while excessive treatment regimens (like 14 days of daily applications) were found to be counterproductive.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcranial Low-Level Laser (Light) Therapy for Brain Injury. Thunshelle, C., Hamblin, MR.[2022]

Transcranial low-level laser therapy (LLLT) shows promise as a treatment for traumatic brain injury (TBI) by promoting neuroprotection, reducing inflammation, and stimulating neurogenesis, based on both animal studies and limited clinical reports.

In studies conducted on mice, specific parameters such as a pulsed frequency of 10 Hz and laser wavelengths of 660 and 810 nm were found to be particularly effective in improving neurological performance and cognitive functions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcranial low level laser (light) therapy for traumatic brain injury. Huang, YY., Gupta, A., Vecchio, D., et al.[2023]

In a study involving 18 older adults with mild cognitive impairment (MCI), those who received photobiomodulation (PBM) showed significant improvements in visual memory performance compared to those who received sham treatment.

PBM also led to a reduction in hemodynamic responses during memory tasks, indicating that it may help decrease the cognitive effort required for high-memory-load tasks, potentially enhancing cognitive performance in individuals with MCI.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Photobiomodulation Enhances Memory Processing in Older Adults with Mild Cognitive Impairment: A Functional Near-Infrared Spectroscopy Study. Chan, AS., Lee, TL., Hamblin, MR., et al.[2021]

Photobiomodulation therapy, which includes low-level laser therapy and light-emitting diodes, has gained significant attention over the past decade for its potential to enhance athletic performance and accelerate post-exercise recovery, as supported by recent systematic reviews and randomized controlled trials.

The article emphasizes the importance of establishing clinical and scientific recommendations based on high-quality evidence to guide the proper use of photobiomodulation therapy, ensuring that future studies avoid relying on less rigorous data such as animal experiments or anecdotal case studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical and scientific recommendations for the use of photobiomodulation therapy in exercise performance enhancement and post-exercise recovery: current evidence and future directions. Leal-Junior, ECP., Lopes-Martins, RÁB., Bjordal, JM.[2022]

Transcranial photobiomodulation (PBM) using NIR light has shown promising results in treating traumatic brain injury (TBI) in mice, leading to improved memory and learning, as well as increased neuroprogenitor cells and synaptogenesis in the brain.

The mechanism of action involves photon absorption in mitochondria, which activates signaling pathways that enhance protective gene expression, suggesting that PBM could have broader applications for various neurological conditions beyond TBI.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Photobiomodulation and the brain: a new paradigm. Hennessy, M., Hamblin, MR.[2020]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5180077/

Transcranial Low-Level Laser (Light) Therapy for Brain Injury Low-level laser therapy (LLLT) or photobiomodulation (PBM) is a possible treatment for brain injury, including traumatic brain injury (TBI).

2. aiche.onlinelibrary.wiley.com aiche.onlinelibrary.wiley.com/doi/10.1002/btm2.10727

Photobiomodulation improves functional recovery after mild ... Our results demonstrate that 810 nm PBM optimally improved functional outcomes after mTBI, reduced markers associated with apoptosis and ...

3. mdpi.com mdpi.com/2073-4409/13/5/385

Traumatic Brain Injury Recovery with Photobiomodulation This study proposes that photobiomodulation (PBM) can effectively modulate the pathophysiology of traumatic brain injury (TBI).

4. journals.sagepub.com journals.sagepub.com/doi/full/10.1089/neu.2022.0140

Photobiomodulation in Acute Traumatic Brain Injury Data were extracted for meta-analysis for neurological severity score and lesion size indices, and other functional and histological outcomes were extracted for ...

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

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

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5803455/

Photobiomodulation for Traumatic Brain Injury and Stroke - PMC Photobiomodulation (PBM) employs red or near-infrared (NIR) light (600-1100nm) to stimulate healing, protect tissue from dying, increase mitochondrial function ...