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New treatment option for Restless Leg Disorder
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
- 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.
- 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
- Pregnancy-related:
- History of preterm labor
- Known fetal anomalies identified prior to enrollment Neurological and neuromuscular disorders:
- Pre-existing neuromuscular disorders affecting balance or gait
- Severe peripheral neuropathy involving the lower legs
- Epilepsy or history of seizures Cardiovascular and circulatory conditions:
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
- Pregnancy-related:
- History of preterm labor
- Known fetal anomalies identified prior to enrollment Neurological and neuromuscular disorders:
- Pre-existing neuromuscular disorders affecting balance or gait
- Severe peripheral neuropathy involving the lower legs
- Epilepsy or history of seizures Cardiovascular and circulatory conditions:
- History of deep vein thrombosis (DVT)
- Circulatory conditions contraindicating peroneal nerve stimulation (PNS) device use Dermatological conditions:
- Skin conditions at device application sites
- Known allergy to device materials Other sleep disorders:
- Inadequately treated severe primary sleep disorders other than RLS (e.g., untreated severe sleep apnea, severe insomnia unrelated to RLS) Device and treatment experience exclusions (based on RESTFUL trial criteria):
- Prior use of the study device or any neurostimulation device for RLS treatment
- Presence of active medical implants (e.g., pacemakers, spinal cord stimulators) Other medical conditions:
- 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 Other exclusions:
- 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's taking place
- 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 - 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?
Study sites include Providence, Rhode Island, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.