The study consists of a series of two 4-week phases:~Phase 1: Prospective, double-blinded, 1:1 randomized (Active treatment: Sham control)~Phase 2: Prospective, non-randomized, non-blinded, Active treatment
Multi-center, prospective double-blind randomized controlled pivotal study of noninvasive peripheral nerve stimulation (NPNS) with the NTX100 Neuromodulation System for patients with medication-refractory moderate-severe primary RLS