Peroneal Electrical Nerve Stimulation in Pregnancy for Restless Legs Syndrome

The TOMAC™ system is a non-invasive, wearable peroneal nerve stimulator that delivers high-frequency electrical stimulation to the common peroneal nerves at the fibular head. It is FDA-cleared for the treatment of moderate-to-severe Restless Legs Syndrome (RLS) in adults but has not been studied in pregnancy. In this trial, pregnant participants will undergo an in-clinic titration session with uterine contraction and fetal monitoring at ≥28 weeks' gestation to determine comfortable therapeutic intensity. They will then use the device at home for 8 weeks, up to four 30-minute sessions daily, prioritizing periods of high symptom burden or before bedtime. Outcomes will assess feasibility, acceptability, adherence, symptom improvement, sleep quality, and maternal-fetal safety.