PENS-P: Peroneal Electrical Nerve Stimulation in Pregnancy for Restless Legs Syndrome (RLS)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 15
- 试验地点
- 3
- 主要终点
- Intervention Appropriateness Measure (IAM) Score
研究概览
简要总结
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.
The main questions the study aims to answer are:
Is TOMAC™ PNS a feasible and acceptable intervention for RLS in pregnant individuals? Are there any maternal, fetal, or neonatal safety concerns with PNS use during pregnancy? What are the patterns of adherence, tolerance, and usability of the TOMAC™ device in this population?
Participants will:
Use a non-invasive TOMAC™ peroneal nerve stimulator during 30-minute sessions as needed, for 8 weeks.
Complete questionnaires assessing feasibility, acceptability, symptom severity, and sleep quality (including AIM, IAM, FIM, IRLS, PGI-I, PSQI, ESS, FOSQ, and MOS-II).
Wear an actigraphy monitor to collect objective sleep data at baseline and at 4 weeks.
Attend scheduled follow-up visits and phone check-ins for maternal vital signs, uterine contraction and fetal monitoring, and neonatal outcome assessment.
This is a prospective, open-label, single-arm pilot study enrolling 15 pregnant participants between 21 and 26 weeks' gestation. Findings will provide the first dataset on the feasibility, acceptability, and safety of TOMAC™ PNS in pregnancy and inform the design of a future randomized controlled trial.
详细描述
This is a prospective, open-label, single-arm pilot study designed to assess the feasibility, acceptability, and preliminary safety of TOMAC™ peroneal electrical nerve stimulation (PNS) for the treatment of Restless Legs Syndrome (RLS) during pregnancy.
RLS affects approximately 20-30% of pregnant individuals, with symptoms often worsening during the second and third trimesters. It is associated with disrupted sleep, decreased quality of life, and adverse pregnancy outcomes such as gestational hypertension, preeclampsia, prolonged labor, and increased cesarean delivery rates. Pharmacologic therapies for RLS are generally avoided during pregnancy because of limited data on fetal safety, highlighting the need for effective, non-pharmacologic alternatives.
The TOMAC™ system is a non-invasive, wearable, high-frequency peroneal nerve stimulator that delivers bilateral stimulation to the common peroneal nerves. It is FDA De Novo granted for use in adults with moderate to severe RLS but has not been evaluated in pregnant populations. Safety rationale for this study is informed by evidence from other neuromodulation therapies, such as sacral nerve stimulation, which have been used safely during pregnancy without observed maternal or fetal harm.
Primary objectives are to evaluate the feasibility and acceptability of TOMAC™ PNS using validated implementation measures, including the Acceptability of Intervention Measure (AIM), Intervention Appropriateness Measure (IAM), and Feasibility of Intervention Measure (FIM).
Secondary objectives include assessment of adherence, dose tolerance, usability, maternal and fetal safety, and exploratory evaluation of symptom improvement and sleep quality through the International Restless Legs Syndrome Rating Scale (IRLS), Patient Global Impression of Improvement (PGI-I), Pittsburgh Sleep Quality Index (PSQI), Epworth Sleepiness Scale (ESS), Functional Outcomes of Sleep Questionnaire (FOSQ), and Medical Outcomes Study Sleep Problem Index II (MOS-II).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Intervention Appropriateness Measure (IAM) Score
时间窗: Baseline and Week 8 of intervention
The Intervention Appropriateness Measure (IAM) is a validated 4-item questionnaire assessing participants' perceptions of how appropriate the intervention is for their condition. Scores range from 1 to 5. Higher scores indicate greater appropriateness.
Feasibility of Intervention Measure (FIM) Score
时间窗: Baseline and Week 8 of intervention
The Feasibility of Intervention Measure (FIM) is a validated 4-item questionnaire assessing participants' perceptions of how feasible it is to use the intervention. Scores range from 1 to 5. Higher scores indicate greater feasibility.
Acceptability of Intervention Measure (AIM) Score
时间窗: Baseline to 8 weeks of intervention
The Acceptability of Intervention Measure (AIM) is a validated 4-item questionnaire assessing participants' perceptions of how acceptable the intervention is. Scores range from 1 to 5. Higher scores indicate greater acceptability.
Intervention Appropriateness Measure (IAM) Score
时间窗: Baseline and Week 8 of intervention
The Intervention Appropriateness Measure (IAM) is a validated 4-item questionnaire assessing participants' perceptions of how appropriate the intervention is for their condition. Scores range from 1 to 5. Higher scores indicate greater appropriateness.
Feasibility of Intervention Measure (FIM) Score
时间窗: Baseline and Week 8 of intervention
The Feasibility of Intervention Measure (FIM) is a validated 4-item questionnaire assessing participants' perceptions of how feasible it is to use the intervention. Scores range from 1 to 5. Higher scores indicate greater feasibility.
次要结局
- Adherence to Maximum Allowed Device Sessions(Throughout 8 weeks of intervention)
- Mean Session Duration(Continuous during 8-week intervention)
- Mean Stimulation Voltage Used During Device Sessions(Continuous during 8-week intervention)
- Number of Participants With Treatment-Related Adverse Events (AEs)(Throughout 8-week intervention)
- Number of Participants With Serious Adverse Events (SAEs)(Throughout 8-week intervention)
- Change in Maternal Systolic Blood Pressure(Baseline, Week 4, Week 8)
- Change in Maternal Diastolic Blood Pressure(Baseline, Week 4, Week 8)
- Change in Maternal Heart Rate(Baseline, Week 4, Week 8)
- Incidence of Uterine Irritability During Titration(At ≥28 weeks of pregnancy during titration session)
- Incidence of Fetal Distress During Titration(At ≥28 weeks of pregnancy during titration session)
- Incidence of Uterine Irritability Associated With Fetal Distress(At ≥28 weeks of pregnancy during titration session)
- Infant Birth Weight(At delivery)
- Neonatal Apgar Score at 1 Minute(At delivery (1 minute))
- Neonatal Apgar Score at 5 Minutes(At delivery (5 minutes))
- Neonatal Health Outcomes at 3 Months Postpartum(3 months postpartum)
- Adherence to Maximum Allowed Device Sessions(Throughout 8 weeks of intervention)
- Mean Session Duration(Continuous during 8-week intervention)
- Mean Stimulation Voltage Used During Device Sessions(Continuous during 8-week intervention)
- Number of Participants With Treatment-Related Adverse Events (AEs)(Throughout 8-week intervention)
- Number of Participants With Serious Adverse Events (SAEs)(Throughout 8-week intervention)
- Change in Maternal Systolic Blood Pressure(Baseline, Week 4, Week 8)
- Change in Maternal Diastolic Blood Pressure(Baseline, Week 4, Week 8)
- Change in Maternal Heart Rate(Baseline, Week 4, Week 8)
- Incidence of Uterine Irritability During Titration(At ≥28 weeks of pregnancy during titration session)
- Incidence of Fetal Distress During Titration(At ≥28 weeks of pregnancy during titration session)
- Incidence of Uterine Irritability Associated With Fetal Distress(At ≥28 weeks of pregnancy during titration session)
- Infant Birth Weight(At delivery)
- Neonatal Apgar Score at 1 Minute(At delivery (1 minute))
- Neonatal Apgar Score at 5 Minutes(At delivery (5 minutes))
- Neonatal Health Outcomes at 3 Months Postpartum(3 months postpartum)