💬In plain words
What the trial is, and whether it could suit you
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, acceptabilit
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
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
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