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

Trial Summary

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 data supports the effectiveness of the treatment Photobiomodulation Therapy (PBMt) for sports concussion?

Research shows that Photobiomodulation Therapy (PBMt) has been used successfully for brain injuries like traumatic brain injury (TBI), with benefits such as reducing inflammation and promoting brain cell growth. Studies also suggest it can improve memory and learning in brain injury models, which may be relevant for treating sports concussions. ^{1 2 3 4 5}

Is photobiomodulation therapy safe for humans?

Photobiomodulation therapy (also known as low-level laser therapy) has been used for over 30 years and is largely considered safe, with studies showing it can help reduce inflammation and support tissue regeneration. ^{1 3 5 6 7}

How is photobiomodulation therapy different from other treatments for sports concussion?

Photobiomodulation therapy (PBMt) is unique because it uses red or near-infrared light to stimulate brain cells, promoting healing and reducing inflammation, which is different from traditional concussion treatments that often focus on rest and symptom management. This therapy targets the mitochondria in cells to enhance cellular repair and growth, offering a novel approach to brain injury recovery. ^{1 2 3 4 8}

What is the purpose of this trial?

The purpose of this study is to compare effects of Photobiomodulation therapy (PBMt) to standard of care in adolescent athletes at risk for delayed recovery from subacute sports concussion, to substantiate the impact of subacute PBMt over time on functional and structural connectivity of the brain using advanced MRI sequences and to correlate the psychological and behavioral outcomes to neuroimaging findings

Research Team

Summer Ott, PsyD

Principal Investigator

The University of Texas Health Science Center, Houston

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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, 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]

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]

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]

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]

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Mechanistic aspects of photobiomodulation therapy in the nervous system. [2022]

2. Brazil 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. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Transcranial Low-Level Laser (Light) Therapy for Brain Injury. [2022]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Photobiomodulation Enhances Memory Processing in Older Adults with Mild Cognitive Impairment: A Functional Near-Infrared Spectroscopy Study. [2021]

5. Germany pubmed.ncbi.nlm.nih.gov

Transcranial low level laser (light) therapy for traumatic brain injury. [2023]

6. England pubmed.ncbi.nlm.nih.gov

Laser oromaxillofacial photobiomodulation therapy: molecular mechanisms, outcomes and considerations. [2022]

7. England 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. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Photobiomodulation and the brain: a new paradigm. [2020]