Peroneal nerve stimulation for restless legs during pregnancy
PENS-P: Peroneal Electrical Nerve Stimulation in Pregnancy for Restless Legs Syndrome (RLS)
This pilot will test whether a wearable TOMAC peroneal nerve stimulator can reduce restless legs symptoms and improve sleep for pregnant people.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 15 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Rhode Island Hospital Academic / other |
| Locations | 2 sites (Providence, Rhode Island and 1 other locations) |
| Trial ID | NCT07144631 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Pregnant individuals aged 18 or older with a singleton pregnancy between 21 and 26 weeks' gestation and a confirmed clinical diagnosis of RLS are the intended candidates.
Not a fit: People with pre-existing neuromuscular disorders, severe peripheral neuropathy, epilepsy, a history of DVT, known fetal anomalies, or those unwilling to use the device or complete follow-up are unlikely to benefit or may be excluded.
Why it matters
Potential benefit: If successful, this could provide a non-drug way to reduce RLS symptoms and improve sleep during pregnancy.
How similar studies have performed: TOMAC has FDA De Novo clearance for adults with moderate to severe RLS and other neuromodulation therapies have been used in pregnancy without clear harm, but TOMAC has not been previously studied in pregnant populations.
Eligibility criteria
Show full inclusion / exclusion 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) 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 this trial is running
Providence, Rhode Island and 1 other locations
- Rhode Island Hospital — Providence, Rhode Island, United States (Not_yet_recruiting)
- Rhode Island Hospital — Providence, Rhode Island, United States (Recruiting)
Study contacts
- Study coordinator: Vesna Buntak, MD
- Email: vbuntak@brownhealth.org
- Phone: 4014444000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.