Introduction
RLS, HF-TOMAC module, sleep disorder
ADVERSE EFFECTS, RESTLESS LEGS SYNDROME (RLS)
Restless legs syndrome (RLS) is a neurological condition and sleep disorder characterized by a distressing urge to move the legs that increases during immobility and worsens during the night [There is a large and growing population of patients with medication-refractory RLS, defined as RLS that is unresponsive to monotherapy with tolerable doses of first-line agents due to reduction in efficacy, augmentation, or adverse effects [Till date, no treatments have been approved by the US Food and Drug Administration (FDA) for patients who are refractory to RLS medication. Consensus expert recommendations suggest that opioids can be effective under careful supervision by a specialist, but side effects can limit tolerability [The TOMAC system (Investigational TOMAC system. (A) The investigational TOMAC system consists of two therapy units corresponding to the Right (R) and Left (L) legs. The exploded view illustrates the components of each therapy unit, consisting of the (1) compressive conduction garment outer side, (2) HF-TOMAC module, which includes the programmable pulse generator, user controls, and rechargeable battery, (3) compressive conduction garment leg-facing side, and (4) charge dispersing interface, which conducts electricity from the HF-TOMAC module to the leg and is shown in an exploded view including disposable protective liners on both sides. (B) The compressive conduction garment of each therapy unit includes the following components (1) Charge port for the rechargeable battery, (2) Intensity lights indicating the stimulation level relative to the titrated value, (3) Status light indicating stimulation and charging status, and (4) Control buttons used to turn therapy on and off and to adjust the stimulation level relative to the titrated value. (C) Depiction of (1) TOMAC therapy unit, shown in light gray, worn so that the (2) charge dispersing interfaces, shown in dark gray, are positioned over the (3) peroneal nerve near (4) the head of the fibula bone.