Key Points Question Is near-infrared low-level light therapy (LLLT) feasible and safe after moderate traumatic brain injury, and does LLLT affect the brain and exhibit neuroreactivity? Findings In this randomized clinical trial including 68 patients with moderate traumatic brain injury who were randomized to receive LLLT or sham therapy, 28 patients completed at least 1 LLLT session without any reported adverse events. In the late subacute stage, there were statistically significant differences in the magnetic resonance imaging–derived diffusion parameters of the white matter tracts between the sham- and light-treated groups, demonstrating neuroreactivity of LLLT. Meaning The results of this clinical trial show that transcranial LLLT is feasible, safe, and affects the brain in a measurable manner.

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