Peroneal Electrical Nerve Stimulation in Pregnancy for Restless Legs Syndrome
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorRhode Island Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Peroneal Nerve Stimulation (PNS) Device
DeviceThe 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.
Treatment groups
15 Participants
are divided into 1 treatment groupGroup A: TOMAC™ Peroneal Nerve StimulationExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Baseline to 8 weeks of intervention2
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.
Time frame
Baseline and Week 8 of intervention3
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.
Time frame
Baseline and Week 8 of interventionSecondary outcomes
1
Adherence to Maximum Allowed Device Sessions
Adherence will be measured as the proportion of actual device sessions used compared to the maximum allowed use (as many as needed 30-minute sessions for 8 weeks). Data will be collected from device logs and participant diaries. Results will be reported as the percentage of completed sessions relative to the maximum allowable sessions.
Time frame
Throughout 8 weeks of intervention2
Mean Session Duration
Average duration of each stimulation session, recorded by device logs. Results will be reported in minutes per session.
Time frame
Continuous during 8-week intervention3
Mean Stimulation Voltage Used During Device Sessions
Average stimulation voltage delivered by the peroneal nerve stimulation (PNS) device during participant sessions, recorded from device logs. Results will be reported as mean voltage across all sessions.
Time frame
Continuous during 8-week intervention4
Number of Participants With Treatment-Related Adverse Events (AEs)
Number of participants experiencing treatment-emergent adverse events related to device use, as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Results will be reported as total number of participants.
Time frame
Throughout 8-week interventionSponsors and contacts
Click on the lead sponsor to view all of their trials.
Rhode Island Hospital
Lead sponsor
American College of Chest Physicians
Collaborator
Source ClinicalTrials.gov