Peroneal Electrical Nerve Stimulation in Pregnancy for Restless Legs Syndrome

A vizsgálat adatai

Ki végzi

Rhode Island Hospital

Azonosító

NCT07144631

A regiszteradat frissítve

2025. november 12.

Eredeti leírás

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.A teljes eredeti leírásKevesebb

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

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.

Bevonási feltételek: 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.

Kizáró feltételek: Known fetal anomalies identified prior to enrollment; Neurological and neuromuscular disorders:; Prior use of the study device or any neurostimulation device for RLS treatment; History of preterm labor; Pre-existing neuromuscular disorders affecting balance or gait; 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):; Presence of active medical implants (e.g., pacemakers, spinal cord stimulators); Other medical conditions:; 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:; Pregnancy-related:; Severe peripheral neuropathy involving the lower legs; Participants undergoing dialysis treatment; Unable or unwilling to operate the device safely and independently; Unable to participate reliably in follow-up assessments or complete self-reported diaries.

ClinicalTrials.gov NCT07144631