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Peroneal Electrical Nerve Stimulation in Pregnancy for Restless Legs Syndrome

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

Who can join

Ages 18 and older · Women

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
* 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

About the study

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.

What is being tested

• Peroneal Nerve Stimulation (PNS) Device (device)

Sponsor: Rhode Island Hospital · Participants: 15 · Started: Oct 15, 2025

Contact the study team

• Vesna Buntak, MD · Phone: 4014444000

Official record on ClinicalTrials.gov — NCT07144631

Locations in the U.S.

Conditions

• Restless Legs
• Sleep Disorders

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.