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Peroneal Electrical Nerve Stimulation for Restless Legs Syndrome in Pregnancy

This study is looking at a new way to help pregnant individuals with Restless Legs Syndrome (RLS). It's testing a wearable device called TOMAC™ that uses gentle electrical stimulation on the leg nerves (peroneal nerve stimulation or PNS). While TOMAC™ is approved for RLS in adults, it hasn't been studied in pregnant individuals before. The main goals are to see if this device is practical, acceptable, and safe for you and your baby during pregnancy. The study also wants to gather early information on how well it helps RLS symptoms and sleep quality. You might be able to join if you are 18 or older, 21-26 weeks pregnant with one baby, and have a confirmed RLS diagnosis. The study is currently unclear on its recruitment status and plans to enroll 15 participants.

Study design
This is a single-arm pilot study, meaning all 15 participants will receive the TOMAC™ device. It is an open-label study, so both you and the researchers will know you are receiving the intervention.
What's involved
The study measures how acceptable, appropriate, and feasible the intervention is at the beginning and after 8 weeks of using the device.
Compensation
Not stated in the trial record.
Follow-up
The study measures outcomes from when you start using the device up to 8 weeks.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07144631

Peroneal Electrical Nerve Stimulation in Pregnancy for Restless Legs Syndrome

Recruiting
NAAges 18+InterventionalTreatment
Rhode Island Hospital
~15 participants
Updated 2025-11-12 on ClinicalTrials.gov
What's tested:Peroneal Nerve Stimulation (PNS) Device

At a glance

Recruiting sites
1 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Acceptability of Intervention Measure (AIM) Score
Measured over Baseline to 8 weeks of intervention
+2 more outcomes measured

Conditions

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

Explore related trials

PregnancyRestless Leg Syndrome

Where it's being run

2 sites across 1 states
Rhode Island2

Who to contact

Vesna Buntak, MD
[email protected]
4014444000
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

History of preterm labor
Known fetal anomalies identified prior to enrollment
Pre-existing neuromuscular disorders affecting balance or gait
Severe peripheral neuropathy involving the lower legs
Epilepsy or history of seizures
History of deep vein thrombosis (DVT)
Circulatory conditions contraindicating peroneal nerve stimulation (PNS) device use
Skin conditions at device application sites
Known allergy to device materials
Prior use of the study device or any neurostimulation device for RLS treatment
Presence of active medical implants (e.g., pacemakers, spinal cord stimulators)
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
Unable or unwilling to operate the device safely and independently
Unable to participate reliably in follow-up assessments or complete self-reported diaries

What this trial measures

  • Acceptability of Intervention Measure (AIM) ScoreBaseline to 8 weeks of intervention

    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.

  • Intervention Appropriateness Measure (IAM) ScoreBaseline and Week 8 of intervention

    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.

  • Feasibility of Intervention Measure (FIM) ScoreBaseline and Week 8 of intervention

    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.