Overview
The goal of this clinical trial is to learn if peroneal nerve stimulation (PNS) can be a feasible, acceptable, and safe way to treat Restless Legs Syndrome (RLS) in pregnant women. It will also gather preliminary information on whether PNS can improve sleep quality and reduce RLS symptoms in this population.
The main questions it aims to answer are:
Is PNS a feasible and acceptable treatment for RLS during pregnancy? Does PNS reduce RLS symptom severity and improve sleep quality in pregnant women? Are there any maternal, fetal, or neonatal safety concerns with PNS use in pregnancy?
Participants will:
Use a non-invasive PNS device for 30-minute sessions, up to four times per day, for 8 weeks Complete questionnaires about symptoms, sleep quality, and device use Wear an actigraphy watch to record sleep patterns Attend scheduled follow-ups for maternal and fetal health assessments
Description
This is a prospective, open-label, single-arm pilot clinical trial designed to evaluate the feasibility, acceptability, safety, and preliminary effectiveness of TOMAC™ peroneal nerve stimulation (PNS) therapy for the treatment of Restless Legs Syndrome (RLS) during pregnancy.
RLS is a common neurological condition affecting 20-30% of pregnant individuals, often worsening in the second and third trimesters. It is associated with impaired sleep quality and adverse pregnancy outcomes such as gestational hypertension, preeclampsia, prolonged labor, and increased cesarean delivery rates. Pharmacologic treatments for RLS are limited during pregnancy due to uncertain fetal safety, creating a critical need for non-pharmacologic alternatives.
The TOMAC™ device delivers high-frequency stimulation to the common peroneal nerve via an externally worn, non-invasive system. It is FDA-cleared for the treatment of moderate-to-severe RLS in adults but has not been studied in pregnancy. Safety is supported by analogous neuromodulation therapies, such as sacral nerve stimulation, which have been used during pregnancy without adverse maternal or fetal outcomes.
Primary objectives are to assess feasibility and acceptability using validated implementation measures: Acceptability of Intervention Measure (AIM), Intervention Appropriateness Measure (IAM), and Feasibility of Intervention Measure (FIM). Secondary objectives include assessing adherence, dose tolerance, usability, symptom improvement, sleep quality, and maternal-fetal safety outcomes.
Fifteen pregnant participants between 21 and 26 weeks' gestation with The International Restless Legs Syndrome Study Group-confirmed RLS will be enrolled. After baseline assessments and device titration under supervision (including uterine contraction and fetal monitoring at ≥28 weeks), participants will use the TOMAC™ device at home for 8 weeks, up to four 30-minute sessions per day, prioritizing times of symptom distress or before bedtime.
Data will be collected from patient-reported outcomes (PGI-I, PSQI, ESS, FOSQ), actigraphy, device usage logs, and maternal-fetal safety monitoring. Follow-up includes biweekly phone calls, a mid-study visit at week 4, a final visit at week 8, and a 3-month postpartum safety check.
This study will generate the first prospective safety and feasibility data for peroneal nerve stimulation in pregnancy and inform the design of a future randomized controlled trial evaluating its effectiveness in improving maternal sleep, reducing RLS symptoms, and potentially lowering the risk of adverse pregnancy outcomes.
Eligibility
Inclusion Criteria:
- Age ≥18 years
- Pregnant individuals between 21 and 26 weeks' gestation at enrollment
- Singleton pregnancy without known fetal anomalies
- Confirmed clinical diagnosis of Restless Legs Syndrome (RLS) according to International Restless Legs Syndrome Study Group (IRLSSG) criteria, confirmed by a sleep medicine specialist to exclude RLS mimics
- Serum ferritin ≥75 µg/L and transferrin saturation ≥20% within 2 months prior to enrollment
- Able and willing to provide informed consent
- Able and willing to comply with study procedures, including device usage, questionnaires, adherence diaries, and follow-up assessments up to 3 months postpartum
Exclusion Criteria:
Pregnancy-related:
- History of preterm labor
- Known fetal anomalies identified prior to enrollment
Neurological and neuromuscular disorders:
- Pre-existing neuromuscular disorders affecting balance or gait
- Severe peripheral neuropathy involving the lower legs
- Epilepsy or history of seizures
Cardiovascular and circulatory conditions:
- History of deep vein thrombosis (DVT)
- Circulatory conditions contraindicating peroneal nerve stimulation (PNS) device use
Dermatological conditions:
- Skin conditions at device application sites
- Known allergy to device materials
Other sleep disorders:
• Inadequately treated severe primary sleep disorders other than RLS (e.g., untreated severe sleep apnea, severe insomnia unrelated to RLS)
Device and treatment experience exclusions (based on RESTFUL trial criteria):
- Prior use of the study device or any neurostimulation device for RLS treatment
- Presence of active medical implants (e.g., pacemakers, spinal cord stimulators)
Other medical conditions:
- Participants undergoing dialysis treatment
- Severe psychiatric conditions (e.g., bipolar disorder, psychosis, severe anxiety or depression) that may interfere with adherence or accurate symptom reporting
- Any condition deemed by investigators to pose safety risks or impede participation
Other exclusions:
- Unable or unwilling to operate the device safely and independently
- Unable to participate reliably in follow-up assessments or complete self-reported diaries