Brain photobiomodulation therapy for acute sport-related concussion: a randomized, single-blinded, pilot clinical trial (RECOVERY study).

BACKGROUND

The current standard of care for concussion relies on symptom management; there are almost no disease-modifying treatments. The RECOVERY study investigated the safety of RGn550 (REGEnLIFE), a novel neurostimulation device combining brain photobiomodulation with a static magnetic field, in sportspeople with acute concussion and described concussion-related parameters in patients receiving this therapy.

METHODS

This prospective, randomized (central randomization, 1:1 ratio), single-blind, monocentric, pilot study compared two pulse frequencies (5 Hz and 10 Hz). Adult sportspeople with a concussion from a shock during sport practice occurring less than 72 h before inclusion were treated for 20 min at day 0 (D0) and D7 and followed up to D52. The primary outcome was the incidence of adverse device effects (ADEs). The secondary outcomes evaluated oculomotor, balance and executive function, concussion symptoms, and blood markers. The sample size was determined by the probability of observing at least one ADE, while all secondary analyses were exploratory and unadjusted for multiplicity.

RESULTS

Fifty patients were included, randomized, and treated at least once with 5 Hz (n = 26) or 10 Hz (n = 24); 49 (98.0%) of them completed the study. No difference was detected between the groups for primary or secondary outcomes. At least one ADE occurred in 38.5% (n = 10) [CI95: 20.2; 59.4] in the 5 Hz group and 41.7% (n = 10) [CI95: 22.1; 63.4] in the 10 Hz group. All ADEs were mild, non-serious (e.g., somnolence and medical device site discomfort), and resolved. Changes in several secondary outcomes were observed over the follow-up period, including within-visit changes in oculomotor measures.

CONCLUSION

No difference in tolerability was detected between the 5 and 10 Hz modalities, although the study was neither designed nor powered to establish equivalence. Both conditions were well tolerated. In the absence of a sham comparator, secondary outcome data are hypothesis-generating and cannot be described in terms of efficacy. However, these data still provide the feasibility and variability estimates required to design an adequately powered, double-blind, sham-controlled trial in an indication that currently lacks disease-modifying treatment.

CLINICAL TRIAL REGISTRATION: https://clinicaltrials.gov/study/NCT05647304, NCT05647304.