Peroneal Electrical Nerve Stimulation in Pregnancy for Restless Legs Syndrome

NCT07144631 | Recruiting DMC FDA Device

• 1 other identifier: 2313348
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 2

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 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, 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.

Conditions

Restless Leg Disorder; Restless Leg Syndrome (RLS); Pregnancy; Sleep Disorder (Disorder)

Keywords

Restless Legs Syndrome; Pregnancy; Sleep Disorders in Pregnancy; Maternal Sleep Health; Peroneal Nerve Stimulation; Neuromodulation

Outcome Measures

Primary Outcomes (3)

• Acceptability of Intervention Measure (AIM) Score

  The Acceptability of Intervention Measure (AIM) is a validated 4-item questionnaire assessing participants' perceptions of how acceptable the intervention is. Scores range from 1 to 5. Higher scores indicate greater acceptability.

  Baseline to 8 weeks of intervention

• Intervention Appropriateness Measure (IAM) Score

  The Intervention Appropriateness Measure (IAM) is a validated 4-item questionnaire assessing participants' perceptions of how appropriate the intervention is for their condition. Scores range from 1 to 5. Higher scores indicate greater appropriateness.

  Baseline and Week 8 of intervention

• Feasibility of Intervention Measure (FIM) Score

  The Feasibility of Intervention Measure (FIM) is a validated 4-item questionnaire assessing participants' perceptions of how feasible it is to use the intervention. Scores range from 1 to 5. Higher scores indicate greater feasibility.

  Baseline and Week 8 of intervention

Secondary Outcomes (15)

• Adherence to Maximum Allowed Device Sessions

  Throughout 8 weeks of intervention

• Mean Session Duration

  Continuous during 8-week intervention

• Mean Stimulation Voltage Used During Device Sessions

  Continuous during 8-week intervention

• Number of Participants With Treatment-Related Adverse Events (AEs)

  Throughout 8-week intervention

• Number of Participants With Serious Adverse Events (SAEs)

  Throughout 8-week intervention

Study Arms (1)

TOMAC™ Peroneal Nerve Stimulation

EXPERIMENTAL

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.

Device: Peroneal Nerve Stimulation (PNS) Device

Interventions

Peroneal Nerve Stimulation (PNS) Device 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.

TOMAC™ Peroneal Nerve Stimulation

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Rhode Island Hospital: lead
• American College of Chest Physicians: collaborator

Study Sites (2)

Rhode Island Hospital

Providence, Rhode Island, 02903, United States

NOT YET RECRUITING

Rhode Island Hospital

Providence, Rhode Island, 02903, United States

RECRUITING

Related Publications (30)

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MeSH Terms

Conditions

Restless Legs Syndrome; Sleep Wake Disorders

Condition Hierarchy (Ancestors)

Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Parasomnias; Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Vesna Buntak, MD

CONTACT

4014444000; vbuntak@brownhealth.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: All enrolled participants will receive the same intervention (TOMAC™ peroneal nerve stimulation). There is no randomization to different arms or a control/placebo group in this pilot study.

Study Record Dates

• First Submitted: August 11, 2025
• First Posted: August 27, 2025
• Study Start: October 15, 2025
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): October 31, 2026
• Last Updated: November 12, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)