Peroneal Electrical Nerve Stimulation in Pregnancy for Restless Legs Syndrome

Recruiting N/A Interventional Study
Restless Leg Disorder Restless Leg Syndrome (RLS) Pregnancy Sleep Disorder (Disorder)
No Placebo Group Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
18 and older
Sex
Female
Study type
Interventional
Purpose
Treatment
Participants needed
15 (estimated)
Sponsor
Rhode Island Hospital · Other
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About This Trial
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 qu…
Trial Locations
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Eligibility Criteria
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) crite…
Contacts

Vesna Buntak, MD

4014444000

vbuntak@brownhealth.org

CONTACT