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NCT07144631 · ClinicalTrials.gov registry record · NA
Peroneal Electrical Nerve Stimulation in Pregnancy for Restless Legs Syndrome
A NA study of Pregnancy and Restless Leg Syndrome (RLS), sponsored by Rhode Island Hospital.
- Recruiting
- Registry status
- NA
- Development phase
- 15
- Enrollment target
- 2
- Study locations
NCT07144631: Recruiting NA study of Pregnancy and Restless Leg Syndrome (RLS), sponsored by Rhode Island Hospital.
NCT07144631 is a NA study of Pregnancy and Restless Leg Syndrome (RLS) that is actively recruiting participants, run by Rhode Island Hospital. The registered enrollment target is 15 participants, below the 873-participant average among 191 other Pregnancy trials with a reported enrollment target (98% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07144631, a NA study of Pregnancy and Restless Leg Syndrome (RLS), is actively recruiting participants, sponsored by Rhode Island Hospital.
- RECRUITING
- Registry status
- NA
- Development phase
- 15 participants
- Enrollment target
- 2
- Study locations
Study 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.
Primary Outcome
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.
Conditions Studied
Interventions
- DEVICE Peroneal Nerve Stimulation (PNS) Device
Study Locations (2)
Rhode Island
- Rhode Island Hospital - Providence
- Rhode Island Hospital - Providence
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2025-10-15 |
| Est. Completion | 2026-10-31 |
| Phase | NA |
What NCT07144631 shows while recruiting
NCT07144631 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 873-participant average among 191 other Pregnancy trials with a reported enrollment target (98% lower).
The record links to 4 conditions, with Pregnancy appearing as the primary indexed condition, and to 1 intervention - of which Peroneal Nerve Stimulation (PNS) Device is the first listed.
NCT07144631 reports a single indexed study location in Rhode Island.
Frequently Asked Questions
What is clinical trial NCT07144631 about?
NCT07144631 is a clinical study titled "Peroneal Electrical Nerve Stimulation in Pregnancy for Restless Legs Syndrome". 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 ...
What is the current status of trial NCT07144631?
This trial is currently recruiting. It is a NA study. The enrollment target is 15 participants. The study started on 2025-10-15. Estimated completion is 2026-10-31.
What conditions does trial NCT07144631 study?
This clinical trial studies the following conditions: Pregnancy, Restless Leg Syndrome (RLS), Restless Leg Disorder, Sleep Disorder (Disorder).
What interventions are being tested in trial NCT07144631?
The interventions under investigation include: Peroneal Nerve Stimulation (PNS) Device (DEVICE).
Who is sponsoring clinical trial NCT07144631?
This trial is sponsored by Rhode Island Hospital, which has 130 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07144631 being conducted?
This trial has 2 study locations across Rhode Island. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT07144631's enrollment target sits among peer trials
15 185th of 191 higher than 4 of 191 other Pregnancy trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Pregnancy trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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