Restless Leg Disorder study: Peroneal Nerve Stimulation
Official title Peroneal Electrical Nerve Stimulation in Pregnancy for Restless Legs Syndrome
ClinicalTrials.gov ID: NCT07144631
What this study is testing
- What it's testing
- This study checks if a small electrical device is safe and easy to use for treating restless legs during pregnancy. It also looks at how it affects sleep and any risks to the mother or baby.
- Who it's for
- Pregnant people between 21 and 26 weeks along who have restless legs syndrome.
- What's involved
- Participants use a small, non-invasive device on their leg for 30-minute sessions as needed. They also fill out questionnaires, wear a sleep tracker, and attend check-ups for health monitoring.
- Time commitment
- The study lasts 8 weeks and includes scheduled visits and phone calls to monitor health.
Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- 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...
- Able and willing to provide informed consent
You likely can't join if
- History of preterm labor
- Pre-existing neuromuscular disorders affecting balance or gait
- Severe peripheral neuropathy involving the lower legs
- History of deep vein thrombosis (DVT)
- Skin conditions at device application sites
- Prior use of the study device or any neurostimulation device for RLS treatment
See the full eligibility 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
- History of preterm labor
- Pre-existing neuromuscular disorders affecting balance or gait
- Severe peripheral neuropathy involving the lower legs
- History of deep vein thrombosis (DVT)
- Skin conditions at device application sites
- Prior use of the study device or any neurostimulation device for RLS treatment
- 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
- Unable or unwilling to operate the device safely and independently
- Unable to participate reliably in follow-up assessments or complete self-reported diaries
The study team makes the final eligibility decision.
Where it is enrolling
- Providence, Rhode Island, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Providence, Rhode Island, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.