Recruiting

PNS

Sponsor:

Rhode Island Hospital

Code:

NCT07144631

Conditions

Restless Leg Disorder

Restless Leg Syndrome (RLS)

Pregnancy

Sleep Disorder (Disorder)

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Peroneal Nerve Stimulation (PNS) Device

Study Details

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)

Study ID

NCT07144631

Start date

Oct 15, 2025

Status verified date

Oct, 2025

Completion date

Oct 31, 2026

Anticipated

Primary completion date

Sep 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

15 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 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.

Interventions

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.

Primary outcome measure

  • Acceptability of Intervention Measure (AIM) Score [ Time Frame: Baseline to 8 weeks of intervention ]
  • Intervention Appropriateness Measure (IAM) Score [ Time Frame: Baseline and Week 8 of intervention ]
  • Feasibility of Intervention Measure (FIM) Score [ Time Frame: Baseline and Week 8 of intervention ]

Central Contacts and Locations

Central contacts

Vesna Buntak, MD

4014444000vbuntak@brownhealth.org

Locations

Rhode Island Hospital

Recruiting

Providence, Rhode Island, United States, 02903

More Information

Sponsor

Rhode Island Hospital

Last update posted

Nov 12, 2025

Last verified

Oct, 2025

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Rhode Island Hospital on 2025-11-12.