RecruitingNot ApplicableNCT07144631

Peroneal Electrical Nerve Stimulation in Pregnancy for Restless Legs Syndrome

PENS-P: Peroneal Electrical Nerve Stimulation in Pregnancy for Restless Legs Syndrome (RLS)

Sponsor

Rhode Island Hospital

Enrollment

15 participants

Start Date

Oct 15, 2025

Study Type

INTERVENTIONAL

Conditions

Pregnancy Restless Leg Syndrome (RLS)Sleep Disorder (Disorder)Restless Leg Disorder

Summary

The goal of this study is to evaluate whether peroneal electrical nerve stimulation (PNS) using the TOMAC™ device is a feasible, acceptable, and safe non-pharmacologic intervention for managing Restless Legs Syndrome (RLS) during pregnancy. This pilot study will also collect preliminary information on symptom relief, sleep quality, and maternal-fetal safety associated with device use. The main questions the study aims to answer are: Is TOMAC™ PNS a feasible and acceptable intervention for RLS in pregnant individuals? Are there any maternal, fetal, or neonatal safety concerns with PNS use during pregnancy? What are the patterns of adherence, tolerance, and usability of the TOMAC™ device in this population? Participants will: Use a non-invasive TOMAC™ peroneal nerve stimulator during 30-minute sessions as needed, for 8 weeks. Complete questionnaires assessing feasibility, acceptability, symptom severity, and sleep quality (including AIM, IAM, FIM, IRLS, PGI-I, PSQI, ESS, FOSQ, and MOS-II). Wear an actigraphy monitor to collect objective sleep data at baseline and at 4 weeks. Attend scheduled follow-up visits and phone check-ins for maternal vital signs, uterine contraction and fetal monitoring, and neonatal outcome assessment. This is a prospective, open-label, single-arm pilot study enrolling 15 pregnant participants between 21 and 26 weeks' gestation. Findings will provide the first dataset on the feasibility, acceptability, and safety of TOMAC™ PNS in pregnancy and inform the design of a future randomized controlled trial.

Eligibility

Sex: FEMALEMin Age: 18 Years

Inclusion Criteria6

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
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 Criteria25

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

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Interventions

DEVICEPeroneal Nerve Stimulation (PNS) Device

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.