Statement of Significance
RLS, medication-refractory RLS
RESTLESS LEGS SYNDROME
Tonic motor activation (TOMAC) is a novel wearable therapeutic device that reduces restless legs syndrome (RLS) symptoms by electrically stimulating specific fibers of the peroneal nerve to activate the tibialis anterior muscle. Medication-refractory RLS requires novel effective and safe treatment options to improve RLS symptoms, sleep, and quality of life. This article presents results from the first randomized, double-blind, sham-controlled trial evaluating the efficacy and safety of TOMAC in adults with medication-refractory RLS. TOMAC treatment produced clinically meaningful reductions in RLS symptoms and had excellent safety and tolerability. Response to TOMAC improved over time, motivating longer-duration open-label studies in the future. These results demonstrate for the first time that TOMAC is a safe and efficacious treatment for refractory RLS.