Evaluating TOMAC12 Peroneal Nerve Stimulation for Restless Legs Syndrome Treatment During Pregnancy

What this Trial Is About

Researchers are evaluating the use of the TOMAC123 peroneal electrical nerve stimulation PNS device as a non-drug treatment for Restless Legs Syndrome RLS during pregnancy. This study aims to determine if the device is feasible, acceptable, and safe for pregnant individuals between 21 and 26 weeks gestation. It also explores symptom relief, sleep quality, and maternal-fetal safety associated with using the device. The study is an open-label, single-arm pilot trial enrolling 15 participants to inform future research. Participants will attend an in-clinic titration session around 28 weeks gestation, where uterine contraction and fetal monitoring will be done to ensure safety and determine a comfortable stimulation level. They will then use the TOMAC123 device at home for 8 weeks, performing up to four 30-minute sessions daily as needed, particularly during times of high symptom burden or before bedtime. The device delivers bilateral high-frequency stimulation to the common peroneal nerves and is FDA-cleared for adults with moderate to severe RLS but not previously studied during pregnancy. During the study, participants will complete various questionnaires assessing device acceptability, symptom severity, and sleep quality. They will wear an actigraphy monitor to gather objective sleep data at baseline and after 4 weeks. Follow-up includes biweekly phone calls, in-person visits at weeks 4 and 8, and a 3-month postpartum safety check. Researchers will monitor maternal vital signs, uterine activity, fetal health, neonatal outcomes, device adherence, and safety throughout the study period.

Peroneal Electrical Nerve Stimulation in Pregnancy for Restless Legs Syndrome