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Pilot Safety Trial Tests Red Light Brain Device In Concussed Athletes

A new device combining red light and magnetic field therapy is being tested for concussion recovery, but this first human trial only checked whether it's safe to use.

By Dr. Axe Editorial Team · September 27, 2026 · 1 source · Watch

A pilot trial published September 22, 2026 in Frontiers in Neurology tested a brain photobiomodulation device, red light therapy combined with a magnetic field, in 50 athletes with acute concussion, finding mild side effects in 38.5% to 41.7% of participants and no difference in tolerability between two treatment settings.

Fifty adult sportspeople with a concussion from a sports impact within the prior 72 hours were randomized 1:1 at one site to two pulse frequencies of a combined photobiomodulation-and-magnetic-field device: 5 Hz in 26 people or 10 Hz in 24 people, in a single-blind pilot study. Sessions lasted 20 minutes on day 0 and day 7, with follow-up through day 52. Forty-nine of 50 people, 98%, completed the study. At least one adverse device effect occurred in 38.5% of the 5 Hz group (10 of 26) and 41.7% of the 10 Hz group (10 of 24); all effects were mild and non-serious, most often drowsiness or discomfort at the device site, and all resolved. No difference was detected between the groups on this safety measure or on secondary tests of eye-tracking, balance, executive function or symptom scores.

Photobiomodulation therapy applies specific wavelengths of red or near-infrared light to tissue. In general, this type of light is thought to support mitochondria, the energy-producing structures inside cells, which may help injured tissue recover energy faster. This trial did not test that mechanism directly; it was designed only to check whether the device itself was safe to use, and without a placebo device group, the secondary changes recorded during follow-up cannot be credited to the treatment.

Adverse Device Effects: 38.5% vs 41.7%

Frontiers in Neurology, 2026, RECOVERY study

The trial had no sham-device comparison group, so it cannot show whether the device changed concussion symptoms or recovery time, only whether it was tolerated. It was a single-site pilot of 50 people, secondary analyses were not adjusted for multiple comparisons, and the trial was funded by REGEnLIFE, which supplied the devices and employs three of the authors.

Dr. Axe’s Take

This trial answers one question: was the device tolerated. It was, in both the 5 Hz and 10 Hz groups, with mild issues like drowsiness in roughly 4 in 10 people that resolved on their own. The researchers are direct that without a placebo device group, none of the eye-movement, balance or symptom changes they recorded can be credited to the treatment. I want to see a sham-controlled follow-up trial before pointing a concussed athlete toward this device. Until then, the plan after a head injury stays the same: immediate evaluation, real rest from screens and exertion, a graded return to activity guided by a physician, and anti-inflammatory foods to support the brain's own recovery.

— Dr. Axe

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Study summary

Who: 50 adult sportspeople with acute sport-related concussion, treated within 72 hours of injury, single site
Design: Randomized 1:1, single-blind pilot trial comparing two pulse frequencies of a photobiomodulation-plus-magnetic-field device; no placebo device group
Dose: 20-minute sessions on day 0 and day 7; 5 Hz frequency (n=26) versus 10 Hz frequency (n=24); followed through day 52
Primary result: At least one adverse device effect occurred in 38.5% (10 of 26) in the 5 Hz group and 41.7% (10 of 24) in the 10 Hz group; no difference detected between groups; all effects mild, non-serious and resolved
Secondary: No difference detected between the two frequency groups on secondary measures of eye-tracking, balance, executive function or symptom scores; changes over follow-up were observed but not attributable to treatment without a placebo comparison group
Funding / conflicts: Funded by REGEnLIFE, which also provided the study devices. Conflicts declared by the authors: two investigators received fees from REGEnLIFE to conduct the study; three authors are REGEnLIFE employees and one of them owns its stock; four are employees of the contract research organization that ran the study for REGEnLIFE; one is a consultant to REGEnLIFE. The paper says the funder took part in study design and manuscript preparation, and that randomization and statistics were done independently by the contract research organization.
Date: Sep 22, 2026