Peroneal Electrical Nerve Stimulation in Pregnancy for Restless Legs Syndrome
15
about 1 year
18+
Female only
1 site in RI
What this study is about
Researchers are testing whether a device called TOMAC™ can help manage restless legs syndrome (RLS) during pregnancy. The trial will evaluate the safety and feasibility of using this device to reduce symptoms, improve sleep quality, and monitor maternal-fetal health. Participants will use the device for 8 weeks and complete questionnaires about their experience.
Simplified from trial records by PatientMatch.
What you may be asked to do
- 1.Use Peroneal Nerve Stimulation (PNS) Device
Participation Burden
What's physically and logistically required of participants.
Requires travel to a study site
How treatment is administered
Everyone gets the investigational treatment.
Extracted study details
Pulled from the trial record to show what is being tested and what the study is measuring.
Primary: Acceptability of Intervention Measure (AIM) Score
Secondary: Change in Maternal Diastolic Blood Pressure, Change in Maternal Heart Rate, Change in Maternal Systolic Blood Pressure, Number of Participants With Serious Adverse Events (SAEs), Number of Participants With Treatment-Related Adverse Events (AEs)
Reproductive Health