Introduction
RLS, neurological and sleep disorder, medication-refractory, primary RLS
DISORDER, RESTLESS LEGS SYNDROME (RLS), SECONDARY
Restless legs syndrome (RLS) is a neurological and sleep disorder characterized by uncomfortable leg sensations and an irresistible urge to move the legs [At least one-third of people with RLS do not have an adequate response to first-line therapeutic agents, dopamine agonists (DAs), and alpha-2-delta ligands, and an additional 5%–20% experience intolerable side effects or augmentation, defined as paradoxical increases in RLS symptoms relative to natural progression of the disorder, with long-term use of DAs [Recognizing the unmet clinical need, in 2020, the US Food and Drug Administration granted a Breakthrough Device designation for an investigational therapeutic device, tonic motor activation (TOMAC) [The efficacy and safety of TOMAC have been demonstrated in two randomized sham-controlled clinical trials with a maximum of 8 weeks of TOMAC treatment. The first of these trials enrolled a mixture of medication-refractory and medication-naïve adults with primary moderate-to-severe RLS who completed 2 weeks of TOMAC treatment and 2 weeks of sham control in a crossover design [The primary objective of this extension study was to assess the longer-term efficacy and safety of TOMAC over 24 weeks for the treatment of medication-refractory moderate-to-severe primary RLS. A secondary objective of this extension study was to characterize changes to RLS symptoms following cessation of TOMAC treatment.