Transcranial Photobiomodulation for Traumatic Brain Injury

Overseen By Michelle Smith

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: NYU Langone Health

Must not be taking: Topiramate, Light-activated drugs

Disqualifiers: Dementia, Brain tumor, Cardiovascular, others

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

Compensation: Varies

Number of Visits: 18

Duration: 6 weeks

70 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it excludes people with unstable medical conditions or those taking medications that impact cognition, like topiramate. It's best to discuss your specific medications with the study team.

What data supports the effectiveness of the treatment Transcranial photobiomodulator (tPBM) for Traumatic Brain Injury?

Research shows that photobiomodulation (PBM) can improve outcomes in traumatic brain injury (TBI) by reducing brain damage and improving recovery in animal studies. It is also considered safe and feasible in human studies, with potential benefits like reducing inflammation and supporting brain cell health. ^{1 2 3 4 5}

Is transcranial photobiomodulation (tPBM) safe for humans?

Transcranial photobiomodulation (tPBM) is generally considered safe in humans, with studies reporting no serious adverse events. Some mild side effects have been noted, but they usually resolve on their own without needing to stop treatment. ^{1 2 3 6 7}

How is transcranial photobiomodulation different from other treatments for traumatic brain injury?

Transcranial photobiomodulation (tPBM) is unique because it uses near-infrared or red light applied to the scalp to activate brain tissues, potentially offering anti-inflammatory and antiapoptotic (preventing cell death) effects. Unlike other treatments, it is non-invasive and aims to enhance brain energy metabolism, which may improve outcomes in traumatic brain injury. ^{1 2 3 4 8}

What is the purpose of this trial?

The purpose of this study is to evaluate the effect of transcranial photobiomodulation (tPBM) in older patients with chronic traumatic brain injury (TBI). The study aims to examine the effect of tPBM on prefrontal cerebral blood flow (CBF) and executive function (EF)

Research Team

Tamara Bushnik, PhD

Principal Investigator

NYU Langone Health

Eligibility Criteria

This trial is for older adults with chronic traumatic brain injury. Participants should be able to give consent and follow the study procedures. Specific details about inclusion and exclusion criteria are not provided, but typically these would outline necessary health conditions, age range, and any factors that could disqualify someone from participating.

Inclusion Criteria

Able to give written informed consent and follow study procedures

I am between 55 and 85 years old.

I have had a serious head injury that affected my consciousness or memory.

Exclusion Criteria

Past intolerance or hypersensitivity to tPBM

DSM-5 diagnosis of alcohol or drug use disorder or history of other major psychiatric illness diagnosed with MINI

Large bilateral prefrontal cortex (PFC) lesions (i.e., more than 50% of our middle frontal gyrus region of interest (ROI) in both hemispheres)

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive transcranial photobiomodulation (tPBM) or sham treatment for 6 weeks, 3 days per week

6 weeks

18 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Transcranial photobiomodulator (tPBM)

Trial Overview The trial is testing transcranial photobiomodulation (tPBM), a non-invasive therapy using light on the brain. Some participants will receive real tPBM treatment while others will get a sham (placebo) version without active light therapy to compare effects on blood flow in the brain and executive function.

Participant Groups

Group I: Active tPBM Experimental Treatment 1 Intervention

Subjects complete 18 t-PBM treatments, \~12 min per day, 3 days per week, for 6 weeks. tPBM will be administered via continuous, 808 nm wavelength laser delivery to the forehead at the standard scalp location.

Group II: Sham tPBM Placebo Group 1 Intervention

Subjects complete 18 sham treatments, \~12 min per day, 3 days per week, for 6 weeks. The sham treatment will be administered to the forehead at the standard scalp location.

Who Is Running the Clinical Trial?

NYU Langone Health

Lead Sponsor

Trials

1,431

Recruited

838,000+

United States Department of Defense

Collaborator

Trials

940

Recruited

339,000+

Findings from Research

Transcranial photobiomodulation (tPBM) is a safe and non-invasive treatment that effectively enhances higher electrophysiological oscillations in the brain, based on a review of 10 studies involving healthy individuals aged 18-80.

While tPBM shows promise in improving brain activity, the evidence regarding its effects on lower oscillatory frequencies remains inconclusive.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of transcranial photobiomodulation on electrophysiological activity of brain in healthy individuals: A scoping review. Shetty, SJ., Shetty, S., Shettigar, D., et al.[2023]

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]

In a study involving 18 participants with major depressive disorder, repeated sessions of near-infrared transcranial photobiomodulation (t-PBM) showed a trend towards more side effects compared to a sham treatment, but these were generally mild and resolved during the study.

The treatment did not lead to significant changes in weight or blood pressure, although a slight increase in diastolic blood pressure was noted, indicating that the overall safety profile of repeated t-PBM sessions appears to be benign.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reported Side Effects, Weight and Blood Pressure, After Repeated Sessions of Transcranial Photobiomodulation. Cassano, P., Caldieraro, MA., Norton, R., et al.[2020]

Transcranial photobiomodulation (tPBM) has shown positive effects on cognitive function in healthy adults and those with cognitive disorders, with 82.9% of the 35 studies reviewed reporting improvements, especially in patients with mild cognitive impairment and dementia.

Despite promising results, particularly in traumatic brain injury patients, the evidence is mixed, and further research is needed as only half of the studies were randomized control trials, indicating a need for more rigorous testing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Can transcranial photobiomodulation improve cognitive function? A systematic review of human studies. Lee, TL., Ding, Z., Chan, AS.[2023]

References

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

Photobiomodulation in Acute Traumatic Brain Injury: A Systematic Review and Meta-Analysis. [2023]

2. Scotland pubmed.ncbi.nlm.nih.gov

Effect of transcranial photobiomodulation on electrophysiological activity of brain in healthy individuals: A scoping review. [2023]

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

Pilot Study on Dose-Dependent Effects of Transcranial Photobiomodulation on Brain Electrical Oscillations: A Potential Therapeutic Target in Alzheimer's Disease. [2021]

5. Netherlands pubmed.ncbi.nlm.nih.gov

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

6. Switzerland pubmed.ncbi.nlm.nih.gov

Transcranial photobiomodulation in the management of brain disorders. [2021]

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

Reported Side Effects, Weight and Blood Pressure, After Repeated Sessions of Transcranial Photobiomodulation. [2020]

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

Can transcranial photobiomodulation improve cognitive function? A systematic review of human studies. [2023]