Peroneal Electrical Nerve Stimulation in Pregnancy for Restless Legs Syndrome
NCT ID: NCT07144631
Last Updated: 2025-11-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
15 participants
INTERVENTIONAL
2025-10-15
2026-10-31
Brief Summary
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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, acceptability, symptom severity, and sleep quality (including AIM, IAM, FIM, IRLS, PGI-I, PSQI, ESS, FOSQ, and MOS-II).
Wear an actigraphy monitor to collect objective sleep data at baseline and at 4 weeks.
Attend scheduled follow-up visits and phone check-ins for maternal vital signs, uterine contraction and fetal monitoring, and neonatal outcome assessment.
This is a prospective, open-label, single-arm pilot study enrolling 15 pregnant participants between 21 and 26 weeks' gestation. Findings will provide the first dataset on the feasibility, acceptability, and safety of TOMAC™ PNS in pregnancy and inform the design of a future randomized controlled trial.
Detailed Description
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RLS affects approximately 20-30% of pregnant individuals, with symptoms often worsening during the second and third trimesters. It is associated with disrupted sleep, decreased quality of life, and adverse pregnancy outcomes such as gestational hypertension, preeclampsia, prolonged labor, and increased cesarean delivery rates. Pharmacologic therapies for RLS are generally avoided during pregnancy because of limited data on fetal safety, highlighting the need for effective, non-pharmacologic alternatives.
The TOMAC™ system is a non-invasive, wearable, high-frequency peroneal nerve stimulator that delivers bilateral stimulation to the common peroneal nerves. It is FDA De Novo granted for use in adults with moderate to severe RLS but has not been evaluated in pregnant populations. Safety rationale for this study is informed by evidence from other neuromodulation therapies, such as sacral nerve stimulation, which have been used safely during pregnancy without observed maternal or fetal harm.
Primary objectives are to evaluate the feasibility and acceptability of TOMAC™ PNS using validated implementation measures, including the Acceptability of Intervention Measure (AIM), Intervention Appropriateness Measure (IAM), and Feasibility of Intervention Measure (FIM).
Secondary objectives include assessment of adherence, dose tolerance, usability, maternal and fetal safety, and exploratory evaluation of symptom improvement and sleep quality through the International Restless Legs Syndrome Rating Scale (IRLS), Patient Global Impression of Improvement (PGI-I), Pittsburgh Sleep Quality Index (PSQI), Epworth Sleepiness Scale (ESS), Functional Outcomes of Sleep Questionnaire (FOSQ), and Medical Outcomes Study Sleep Problem Index II (MOS-II).
Fifteen pregnant individuals between 21 and 26 weeks of gestation with a confirmed diagnosis of RLS will be enrolled. Following baseline assessments, participants will undergo an in-person titration session under clinical supervision, which includes uterine contraction and fetal monitoring performed at ≥28 weeks' gestation to ensure maternal and fetal safety.
Participants will then use the TOMAC™ device at home for an 8-week intervention, performing self-administered 30-minute sessions as needed, preferably during periods of symptom distress or prior to sleep.
Data will be collected from patient-reported outcomes, actigraphy sleep recordings, device usage logs, and maternal-fetal safety monitoring. Follow-up includes biweekly phone check-ins, an in-person mid-study visit at week 4, a final in-person visit at week 8, and a three-month postpartum safety follow-up.
This pilot study will generate the first prospective data on the feasibility, acceptability, and safety of peroneal nerve stimulation in pregnancy, providing foundational evidence for future randomized controlled trials evaluating TOMAC™ PNS as a pregnancy-safe, non-pharmacologic treatment for RLS and its potential to improve maternal sleep and pregnancy outcomes.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
There is no randomization to different arms or a control/placebo group in this pilot study.
TREATMENT
NONE
Study Groups
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TOMAC™ Peroneal Nerve Stimulation
Participants will receive TOMAC™ peroneal nerve stimulation (PNS) therapy for Restless Legs Syndrome (RLS) during pregnancy. Following a supervised in-clinic titration session with uterine contraction and fetal monitoring at ≥28 weeks' gestation, participants will use the device at home for 8 weeks. Each therapy session lasts 30 minutes and can be performed as many times as needed daily, prioritizing periods of high symptom burden or before bedtime. Outcomes include feasibility, acceptability, adherence and maternal-fetal safety.
Peroneal Nerve Stimulation (PNS) Device
The TOMAC™ system is a non-invasive, wearable peroneal nerve stimulator that delivers high-frequency electrical stimulation to the common peroneal nerves at the fibular head. It is FDA-cleared for the treatment of moderate-to-severe Restless Legs Syndrome (RLS) in adults but has not been studied in pregnancy. In this trial, pregnant participants will undergo an in-clinic titration session with uterine contraction and fetal monitoring at ≥28 weeks' gestation to determine comfortable therapeutic intensity. They will then use the device at home for 8 weeks, up to four 30-minute sessions daily, prioritizing periods of high symptom burden or before bedtime. Outcomes will assess feasibility, acceptability, adherence, symptom improvement, sleep quality, and maternal-fetal safety.
Interventions
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Peroneal Nerve Stimulation (PNS) Device
The TOMAC™ system is a non-invasive, wearable peroneal nerve stimulator that delivers high-frequency electrical stimulation to the common peroneal nerves at the fibular head. It is FDA-cleared for the treatment of moderate-to-severe Restless Legs Syndrome (RLS) in adults but has not been studied in pregnancy. In this trial, pregnant participants will undergo an in-clinic titration session with uterine contraction and fetal monitoring at ≥28 weeks' gestation to determine comfortable therapeutic intensity. They will then use the device at home for 8 weeks, up to four 30-minute sessions daily, prioritizing periods of high symptom burden or before bedtime. Outcomes will assess feasibility, acceptability, adherence, symptom improvement, sleep quality, and maternal-fetal safety.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
FEMALE
No
Sponsors
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American College of Chest Physicians
OTHER
Rhode Island Hospital
OTHER
Responsible Party
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Locations
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Rhode Island Hospital
Providence, Rhode Island, United States
Rhode Island Hospital
Providence, Rhode Island, United States
Countries
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Central Contacts
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Facility Contacts
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Vesna Buntak, MD
Role: primary
References
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Other Identifiers
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2313348
Identifier Type: -
Identifier Source: org_study_id