Idiopathic and secondary restless legs syndrome during pregnancy in Japan: Prevalence, clinical features and delivery-related outcomes.
Chikara Yoshimura, Hisatomi Arima, Hironobu Amagase...
https://pubmed.ncbi.nlm.nih.gov/33974646Actively Recruiting
Phase Not Applicable
Age: 18Years +
FEMALE
ID07144631
PENS-P Peroneal Electrical Nerve Stimulation in Pregnancy for Restless Legs Syndrome (RLS)
Led by Rhode Island Hospital · Updated on 2025-11-12
15
Participants Needed
2
Research Sites
4 weeks
Total Duration
On this page
Sponsors
R
Rhode Island Hospital
Lead Sponsor
A
American College of Chest Physicians
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the use of the TOMAC123 peroneal electrical nerve stimulation (PNS) device as a non-drug treatment for Restless Legs Syndrome (RLS) during pregnancy. This study aims to determine if the device is feasible, acceptable, and safe for pregnant individuals between 21 and 26 weeks' gestation. It also explores symptom relief, sleep quality, and maternal-fetal safety associated with using the device. The study is an open-label, single-arm pilot trial enrolling 15 participants to inform future research. Participants will attend an in-clinic titration session around 28 weeks' gestation, where uterine contraction and fetal monitoring will be done to ensure safety and determine a comfortable stimulation level. They will then use the TOMAC123 device at home for 8 weeks, performing up to four 30-minute sessions daily as needed, particularly during times of high symptom burden or before bedtime. The device delivers bilateral high-frequency stimulation to the common peroneal nerves and is FDA-cleared for adults with moderate to severe RLS but not previously studied during pregnancy. During the study, participants will complete various questionnaires assessing device acceptability, symptom severity, and sleep quality. They will wear an actigraphy monitor to gather objective sleep data at baseline and after 4 weeks. Follow-up includes biweekly phone calls, in-person visits at weeks 4 and 8, and a 3-month postpartum safety check. Researchers will monitor maternal vital signs, uterine activity, fetal health, neonatal outcomes, device adherence, and safety throughout the study period.
CONDITIONS
Brief Title
Peroneal Electrical Nerve Stimulation in Pregnancy for Restless Legs Syndrome
Who Can Participate
Age: 18Years +
FEMALE
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Pregnant individuals between 21 and 26 weeks' gestation at enrollment
- Singleton pregnancy without known fetal anomalies
- Confirmed clinical diagnosis of Restless Legs Syndrome (RLS) by a sleep medicine specialist
- Able and willing to provide informed consent
- Able and willing to comply with study procedures, including device usage, questionnaires, diaries, and follow-up up to 3 months postpartum
You will not qualify if you...
- History of preterm labor
- Known fetal anomalies identified before enrollment
- Pre-existing neuromuscular disorders affecting balance or gait
- Severe peripheral neuropathy involving the lower legs
- Epilepsy or history of seizures
- History of deep vein thrombosis (DVT)
- Circulatory conditions contraindicating peroneal nerve stimulation device use
- Skin conditions at device application sites
- Known allergy to device materials
- Untreated severe primary sleep disorders other than RLS
- Prior use of the study device or any neurostimulation device for RLS
- Presence of active medical implants like pacemakers or spinal cord stimulators
- Undergoing dialysis treatment
- Severe psychiatric conditions interfering with study participation
- Unable or unwilling to safely operate the device
- Unable to reliably participate in follow-up assessments or complete diaries
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 8 weeks
Participants undergo an in-person supervised titration session with uterine contraction and fetal monitoring at 28 weeks or later to determine comfortable therapeutic intensity. Following titration, participants use the TOMAC™ device at home for an 8-week intervention, performing self-administered 30-minute sessions as needed, preferably during symptom distress or before sleep.
1 in-person titration visit, 1 in-person mid-study visit at week 4, 1 in-person final visit at week 8, and biweekly phone check-ins
Follow-up
Duration - 3 months postpartum
Participants are followed for safety monitoring through a postpartum visit at 3 months after delivery to assess maternal and neonatal health outcomes.
1 in-person postpartum visit
Trial Site Locations
Total: 2 locations
1
Rhode Island Hospital
Providence, Rhode Island, United States, 02903
Not Yet Recruiting
2
Rhode Island Hospital
Providence, Rhode Island, United States, 02903
Actively Recruiting
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Research Team
V
Vesna Buntak, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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John W Winkelman, J Andrew Berkowski, Lourdes M DelRosso...
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Bryan J Weiner, Cara C Lewis, Cameo Stanick...
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Jacek K Szymański, Aneta Słabuszewska-Jóźwiak, Grzegorz Jakiel
https://pubmed.ncbi.nlm.nih.gov/35886191Maternal and neonatal outcomes associated with restless legs syndrome in pregnancy: A systematic review.
Kate Steinweg, Tanya Nippita, Peter A Cistulli...
https://pubmed.ncbi.nlm.nih.gov/32805557Restless legs syndrome and pregnancy: a review.
Prachaya Srivanitchapoom, Sanjay Pandey, Mark Hallett
https://pubmed.ncbi.nlm.nih.gov/24768121