LED Therapy for Traumatic Brain Injury

(LED-TBI Trial)

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Disqualifiers: Penetrating head injury, Neurological diagnosis, Psychotic disorder, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether light therapy using LED lights can improve thinking, mood, and quality of life for people with traumatic brain injury (TBI). Participants will receive either an active LED treatment or a sham (inactive) LED treatment for comparison. The trial seeks OEF/OIF active-duty personnel or veterans who have experienced a mild TBI or blast exposure with a brief loss of consciousness. As an unphased trial, this study offers participants the chance to contribute to groundbreaking research that could enhance future TBI treatments.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this LED therapy is safe for traumatic brain injury?

Research has shown that LED therapy is generally safe for people. In two studies involving 115 healthy participants, LED-red light on the skin proved safe even at high levels, indicating it is usually well-tolerated. Another study examined LED therapy for individuals with mild traumatic brain injury and found no serious side effects. While these results are encouraging, individual experiences may vary. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Most treatments for traumatic brain injury, like medication and physical therapy, focus on managing symptoms rather than healing the brain directly. But LED therapy is unique because it uses light to stimulate brain cells, potentially promoting healing at the cellular level. Researchers are excited about this treatment because it offers a non-invasive option that could directly aid brain recovery, unlike traditional methods that primarily address symptoms. Additionally, LED therapy may have fewer side effects compared to medication, making it a promising alternative for patients.

What evidence suggests that LED therapy is effective for traumatic brain injury?

Research has shown that LED therapy, particularly with red and near-infrared light, can enhance brain function and blood flow in individuals with traumatic brain injury (TBI). For instance, a study of veterans with mild TBI found that those who received LED therapy demonstrated better thinking skills and sleep. Other studies have reported significant improvements in cognitive abilities after LED treatments in individuals with long-term TBI. Another trial indicated that LED therapy enhanced thinking skills in patients with mild traumatic brain injury (mTBI). These findings suggest that LED therapy, which participants in this trial may receive, could effectively improve cognitive function and overall quality of life for those with TBI. ^{1 2 3 6 7}

Who Is on the Research Team?

Yelena Bogdanova, PhD PhD

Principal Investigator

VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

Are You a Good Fit for This Trial?

This trial is for English-speaking adults aged 21-55 who have experienced a mild traumatic brain injury (TBI) with loss of consciousness for no more than 30 minutes. It's specifically aimed at active-duty personnel or veterans exposed to blasts. People with penetrating head injuries, previous neurological or psychotic disorders, or significant hearing or vision impairments cannot participate.

Inclusion Criteria

LOC of 30 min or less

Veterans who have had a traumatic brain injury or exposure to blasts during their service in Iraq or Afghanistan.

I am between 21 and 55 years old.

Exclusion Criteria

I have a history of neurological conditions.

You had a mental illness like schizophrenia before a head injury.

I have difficulty with my hearing or vision.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either active LED treatment or sham LED treatment to improve cognition and neuropsychiatric status

8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• LED
• sham LED

Trial Overview The study is testing the effectiveness of light emitting diodes (LED) therapy compared to a fake LED treatment (sham) in improving cognitive function and quality of life for those with TBI. Participants will be randomly assigned to receive either the real LED treatment or sham.

How Is the Trial Designed?

Group I: Active LED Experimental Treatment 1 Intervention

Active LED Treatment

Group II: Sham LED Placebo Group 1 Intervention

Inactive (sham) LED Treatment

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Published Research Related to This Trial

Transcranial photobiomodulation (tPBM) using red and near-infrared LEDs has shown significant improvements in cognitive function and reduced PTSD symptoms in chronic traumatic brain injury (TBI) patients, based on a study of 11 patients who received 18 treatments over 6 weeks.

The LED therapy is noninvasive and painless, and ongoing studies are exploring its effects on sleep and cognitive function in TBI patients, with promising results indicating increased sleep duration and continued cognitive benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcranial, Red/Near-Infrared Light-Emitting Diode Therapy to Improve Cognition in Chronic Traumatic Brain Injury. Naeser, MA., Martin, PI., Ho, MD., et al.[2017]

Transcranial LED treatments showed significant cognitive improvements in two chronic TBI patients, with one patient increasing her sustained attention from 20 minutes to 3 hours after eight weekly sessions.

Both patients experienced notable recovery in cognitive functions and quality of life, suggesting that transcranial LED therapy could be a promising home-based treatment for chronic TBI, warranting further controlled studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improved cognitive function after transcranial, light-emitting diode treatments in chronic, traumatic brain injury: two case reports. Naeser, MA., Saltmarche, A., Krengel, MH., et al.[2021]

In two phase I clinical trials involving 115 healthy participants, LED-red light (LED-RL) was found to be safe at fluences up to 320 J/cm2 for skin of color and 480 J/cm2 for non-Hispanic Caucasians, with only mild adverse events reported.

The study identified that dose-limiting adverse events, such as blistering, occurred at higher fluences, indicating that LED-RL may have different effects based on skin type, which is important for guiding future therapeutic applications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of light emitting diode-red light on human skin: Two randomized controlled trials. Jagdeo, J., Nguyen, JK., Ho, D., et al.[2022]

In a study involving 12 military Veterans with chronic traumatic brain injury (TBI), pulsed transcranial photobiomodulation therapy (PBMT) using LEDs significantly improved neuropsychological scores in 40% of the assessed areas, indicating potential cognitive benefits.

SPECT imaging revealed increased regional cerebral blood flow (rCBF) in 66.7% of participants, suggesting that LED therapy may enhance brain function years after injury, although further research with larger sample sizes is needed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pulsed Transcranial Red/Near-Infrared Light Therapy Using Light-Emitting Diodes Improves Cerebral Blood Flow and Cognitive Function in Veterans with Chronic Traumatic Brain Injury: A Case Series. Hipskind, SG., Grover, FL., Fort, TR., et al.[2020]

This study is a double-blinded, randomized controlled trial involving 32 patients with diffuse axonal injury from severe traumatic brain injury, testing the effects of transcranial LED therapy on cognitive function and cerebral circulation.

The therapy involves 18 sessions of LED stimulation over 6 weeks, and aims to improve cognitive outcomes and promote beneficial changes in blood flow to the brain, addressing a gap in clinical trials for TBI cognitive rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of transcranial LED therapy on the cognitive rehabilitation for diffuse axonal injury due to severe acute traumatic brain injury: study protocol for a randomized controlled trial. Santos, JGRPD., Zaninotto, ALC., Zângaro, RA., et al.[2023]

Citations

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

Significant Improvements in Cognitive Performance Post ... Improved cognitive function after transcranial, light-emitting diode treatments in chronic, traumatic brain injury: two case reports. Photomed. Laser Surg ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT02383472

LED Therapy for the Treatment of Concussive Brain Injury A double blind randomized trial of light-emitting diode (LED) therapy for patients suffering from mild traumatic brain injury (mTBI). Patients seen in the ...

3. withpower.com withpower.com/trial/led-therapy-for-traumatic-brain-injury-fff8e

LED Therapy for Traumatic Brain Injury · Info for Participants Research shows that using red and near-infrared light therapy with LEDs can improve brain function and blood flow in people with chronic traumatic brain injury.

4. trialsjournal.biomedcentral.com trialsjournal.biomedcentral.com/articles/10.1186/s13063-018-2632-5

Effects of transcranial LED therapy on the cognitive ... - Trials The study hypotheses are as follows: (1) transcranial LED therapy (TCLT) will improve the cognitive function of DAI patients and (2) TCLT will ...

5. psychiatryonline.org psychiatryonline.org/doi/10.1176/appi.pn.2018.1b8

LED Therapy Offers New Hope to Veterans With TBI, PTSD A double-blind, sham-controlled clinical trial of veterans with mild TBI funded by the VA found that cognition and sleep improved in veterans who received LED ...

6. jneuroengrehab.biomedcentral.com jneuroengrehab.biomedcentral.com/articles/10.1186/s12984-024-01351-8

Devices used for photobiomodulation of the brain—a ... Improved cognitive function after transcranial, light-emitting diode treatments in chronic, traumatic brain injury: two case reports.

7. aslms.org aslms.org/for-the-public/general-information/devices---led's/led-therapy-studies

LED Therapy Studies Scalp application of red/near-infrared LED was observed to significantly improve executive function and verbal memory in persons with chronic, TBI.