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.
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