Status:
RECRUITING
Peroneal Electrical Nerve Stimulation in Pregnancy for Restless Legs Syndrome
Lead Sponsor:
Rhode Island Hospital
Collaborating Sponsors:
American College of Chest Physicians
Conditions:
Restless Leg Disorder
Restless Leg Syndrome (RLS)
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief 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 Restle...
Detailed Description
This is a prospective, open-label, single-arm pilot study designed to assess the feasibility, acceptability, and preliminary safety of TOMAC™ peroneal electrical nerve stimulation (PNS) for the treatm...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 15 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 31 2026
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT07144631
Start Date
October 15 2025
End Date
October 31 2026
Last Update
November 12 2025
Active Locations (2)
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1
Rhode Island Hospital
Providence, Rhode Island, United States, 02903
2
Rhode Island Hospital
Providence, Rhode Island, United States, 02903