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NCT07144631: PENS-P
Peroneal Electrical Nerve Stimulation in Pregnancy for Restless Legs Syndrome
NA trial testing Peroneal Nerve Stimulation (PNS) Device in Restless Leg Disorder in 15 participants. Currently enrolling.
30 September 2026
Quick facts
| Lead sponsor | Rhode Island Hospital |
|---|---|
| Phase | NA |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 15 |
| Start date | 15 October 2025 |
| Primary completion | 30 September 2026 |
| Estimated completion | 31 October 2026 |
| Sites | 2 locations across United States |
Drugs / interventions tested
- Peroneal Nerve Stimulation (PNS) Device
Conditions studied
- Restless Leg Disorder — all drugs for Restless Leg Disorder →
- Restless Leg Syndrome (RLS) — all drugs for Restless Leg Syndrome (RLS) →
- Pregnancy — all drugs for Pregnancy →
- Sleep Disorder (Disorder) — all drugs for Sleep Disorder (Disorder) →
Sponsor
Rhode Island Hospital
Who can join
18 and older, female only, with Restless Leg Disorder or Restless Leg Syndrome (RLS). Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT07144631
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07144631 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Rhode Island Hospital
- Last refreshed: 12 November 2025
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