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

8 Participants Needed

Trial Summary

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 data supports the effectiveness of LED therapy for traumatic brain injury?

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. Studies have reported better cognitive performance and increased blood flow in the brain after LED treatment. ^{1 2 3 4 5}

Is LED therapy safe for humans?

LED therapy, including red and near-infrared light, is generally considered safe for humans. Studies have shown that it is noninvasive, painless, and does not cause serious side effects. Some mild skin reactions like temporary redness or darkening may occur, but no serious adverse events have been reported. ^{1 2 3 4 6}

How does LED therapy differ from other treatments for traumatic brain injury?

LED therapy for traumatic brain injury is unique because it uses red and near-infrared light to improve brain function by enhancing blood flow and cellular energy without being invasive or causing pain. This treatment is non-thermal and can be administered at home, making it different from other more invasive or drug-based therapies. ^{2 3 4 7 8}

What is the purpose of this trial?

This trial tests if special lights can help people with brain injuries by making their brain cells work better. It aims to improve memory, sleep, and overall quality of life. Previous research has shown that using these lights after a brain injury can protect brain cells.

Research Team

Yelena Bogdanova, PhD PhD

Principal Investigator

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

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

References

1. United States 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. [2019]

2. United States 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. [2020]

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

Improved cognitive function after transcranial, light-emitting diode treatments in chronic, traumatic brain injury: two case reports. [2021]

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

Significant improvements in cognitive performance post-transcranial, red/near-infrared light-emitting diode treatments in chronic, mild traumatic brain injury: open-protocol study. [2021]

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

Effect of Transcranial Low-Level Light Therapy vs Sham Therapy Among Patients With Moderate Traumatic Brain Injury: A Randomized Clinical Trial. [2021]

6. Germany pubmed.ncbi.nlm.nih.gov

Safety of light emitting diode-red light on human skin: Two randomized controlled trials. [2022]

7. England 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. [2023]

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

Transcranial, Red/Near-Infrared Light-Emitting Diode Therapy to Improve Cognition in Chronic Traumatic Brain Injury. [2017]