Peroneal nerve stimulation for restless legs during pregnancy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, open-label, single-arm pilot that tests feasibility, acceptability, and preliminary safety of TOMAC peroneal electrical nerve stimulation in pregnant individuals with RLS. Participants use a non-invasive wearable peroneal nerve stimulator for 30-minute sessions as needed over an 8-week period and complete validated questionnaires and adherence diaries. The protocol includes follow-up through three months postpartum to capture maternal, fetal, and neonatal safety signals as well as patterns of device tolerance and usability. Primary outcomes are implementation measures (AIM, IAM, FIM), with secondary measures of symptom severity and sleep quality (IRLS, PGI-I, PSQI, ESS) and maternal-fetal safety monitoring.

Why it matters

Who can join: the full rules

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

Where it's running

• Rhode Island Hospital
  Providence, Rhode Island, United States Recruiting
• Rhode Island Hospital
  Providence, Rhode Island, United States Not yet recruiting

Study contacts

• Study coordinator: Vesna Buntak, MD
• Email: vbuntak@brownhealth.org
• Phone: 4014444000

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.