Treatment of chronic symptoms following mild traumatic brain injury with transcranial LED: a sham run-in pilot study of photobiomodulation therapy

ABSTRACT

Primary Objective

We evaluated whether photobiomodulation with red/near infrared light applied transcranially via light emitting diodes (LED) was associated with reduced symptoms and improved cognitive functioning in patients with chronic symptoms following mild traumatic brain injury.

Research Design

Participants (3 men, 6 women; 22–61 years-old) underwent a 6-week intervention involving 18 40-minute transcranial LED treatment sessions.

Methods and Procedures

Reliable change indices were calculated for 10 neuropsychological test scores and 3 self-report questionnaires of subjective cognition, post-concussion symptoms, and depression at baseline and following treatment. Questionnaires were also administered after 2-week sham and at 1-month and 2-month follow-ups.

Main Outcome and Results

Only 2 participants improved on neuropsychological testing. On questionnaires, 4 reported improved cognition, 5 reported improved post-concussion symptoms, and 3 reported improved depression. Significant improvement in 2 or more domains was reported by 4 participants and mostly maintained at both follow-ups.

Conclusions

Most participants did not improve on neuropsychological testing. A minority self-reported improvement in symptoms, potentially explained by the intervention, psychiatric medication changes, placebo effects, or other factors. Selecting participants with different clinical characteristics, and dosing and delivery system changes, may produce different results. A study design accounting for placebo effects appears warranted in future trials.

KEYWORDS:

• Brain concussion
• Post-Concussion Syndrome
• Phototherapy
• Rehabilitation
• Brain Injuries, Traumatic

Disclosure statement

Dr. Grant Iverson serves as a scientific advisor for NanoDX®, Sway Operations, LLC, and Highmark, Inc. He has a clinical and consulting practice in forensic neuropsychology, including expert testimony, involving individuals who have sustained mild TBIs. He has received past research support or funding from several test publishing companies, including ImPACT Applications, Inc., CNS Vital Signs, and Psychological Assessment Resources (PAR, Inc.). He receives royalties from the sales of one neuropsychological test (WCST-64). He has received research funding as a principal investigator from the National Football League, and subcontract grant funding as a collaborator from the Harvard Integrated Program to Protect and Improve the Health of National Football League Players Association Members. He has received research funding from the Wounded Warrior Project™. He acknowledges unrestricted philanthropic support from ImPACT Applications, Inc., the Mooney-Reed Charitable Foundation, the National Rugby League, Boston Bolts, and the Schoen Adams Research Institute at Spaulding Rehabilitation. Dr. Ross Zafonte receives royalties from Demos Medical Publishing, an imprint of Springer Publishing Company, for serving as co-editor of Brain Injury Medicine. He has received salary support from the Harvard Integrated Program to Protect and Improve the Health of National Football League Players Association Members. He also evaluates patients in the MGH Brain and Body-TRUST Program, which is funded by the NFL Players Association. He serves on the Scientific Advisory Board of Myomo, Nanodiagnostics, Kisbee and Onecare.ai

Additional information

Funding

This study was supported, in part, by the Football Players Health Study at Harvard University. Justin E. Karr acknowledges funding from the Spaulding Research Institute Leadership Catalyst Fellowship.