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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a treatment called transcranial photobiomodulation (tPBM) to improve brain blood flow and thinking skills in older adults who have experienced a traumatic brain injury (TBI). The researchers aim to determine if this light therapy, applied near the forehead, can aid recovery. Participants will receive either the actual treatment or a sham treatment for comparison. Ideal candidates have experienced a moderate to severe brain injury, with symptoms persisting between one and two years. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could enhance recovery options for TBI patients.

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 prior data suggests that transcranial photobiomodulation is safe for older patients with chronic traumatic brain injury?

Research has shown that transcranial photobiomodulation (tPBM) is generally safe. A review of 16 studies found that tPBM can improve brain function without major safety issues. Another study noted that it aids in recovering from brain injuries and did not report any serious side effects.

While these studies suggest that tPBM is usually well-tolerated, individual experiences can differ. Participants should discuss any concerns with the medical team conducting the trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike traditional treatments for traumatic brain injury (TBI), which often involve medication and rehabilitation therapies, transcranial photobiomodulation (tPBM) uses a novel approach by delivering light therapy directly to the brain. This method involves using an 808 nm wavelength laser targeted at the forehead, which is believed to stimulate brain cells and promote healing. Researchers are excited about tPBM because it offers a non-invasive, drug-free option that could potentially enhance brain recovery without the side effects associated with pharmaceuticals.

What evidence suggests that transcranial photobiomodulation is effective for traumatic brain injury?

Research has shown that transcranial photobiomodulation (tPBM) can aid recovery from traumatic brain injury (TBI). Studies have found that tPBM may enhance cognitive skills, such as memory and problem-solving, in individuals with long-term TBI. One study found that patients performed better on cognitive tests after using tPBM. Another study suggested that tPBM might help by reducing brain swelling, a common occurrence after TBI. In this trial, participants will receive either active tPBM or a sham treatment to evaluate its effectiveness. Overall, these findings suggest that tPBM could be a beneficial treatment for improving brain function in TBI patients. ^{1 2 3 5 6}

Who Is on the Research Team?

Tamara Bushnik, PhD

Principal Investigator

NYU Langone Health

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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 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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12595661/

a study of 1064 nm light-emitting diodes - PMC Transcranial photobiomodulation promotes traumatic brain injury recovery via modulating glial cell polarization and neuroinflammation: a ...

2. mdpi.com mdpi.com/2304-6732/11/3/260

Transcranial Photobiomodulation and Chronic Traumatic ... This review includes 16 studies, which concluded that after tPBM application, there were improvements in neuropsychological outcomes in addition ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06956404

tPBM in Older Adults With Traumatic Brain Injury The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure.

4. frontiersin.org frontiersin.org/journals/psychology/articles/10.3389/fpsyg.2024.1378570/full

Can transcranial photobiomodulation improve cognitive ... Conclusion: Results showed improvements in cognition for patients with chronic TBI after tPBM intervention. The mechanism may be that tPBM ...

5. bmcpsychiatry.biomedcentral.com bmcpsychiatry.biomedcentral.com/articles/10.1186/s12888-025-06555-3

The effectiveness of Transcranial Photobiomodulation therapy ... tPBMT led to significant improvements in anxiety, depression, and opioid craving among individuals in MMT, and these improvements were sustained at one month ...

6. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1011134421000865

Transcranial photobiomodulation in the management of ... The aim of this review was to determine the existing evidence of effectiveness, useful parameters, and safety of tPBM in the management of traumatic brain ...