Could a simple nerve zap soothe restless legs in pregnancy?
NCT ID NCT07144631
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a small, non-invasive device that stimulates a nerve in the leg to see if it can safely ease Restless Legs Syndrome (RLS) during pregnancy. Fifteen pregnant women between 21 and 26 weeks will use the device for 30-minute sessions over 8 weeks. Researchers will check if the treatment is acceptable, easy to use, and safe for both mother and baby, while also gathering early data on symptom relief and sleep quality.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 15 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Oct 2025
- Expected to finish
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Oct 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion 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 Exclusion Criteria: 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
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Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
2 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Rhode Island Hospital
NOT_YET_RECRUITINGProvidence, Rhode Island, 02903, United States
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Rhode Island Hospital
RECRUITINGProvidence, Rhode Island, 02903, United States
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