NCT06076499进行中（未招募）不适用
A Post-Market Observational Clinical Study to Determine the Long-Term Effectiveness and Safety of the Noctrix TOMAC (Tonic Motor Activation) System for the Treatment of Restless Legs Syndrome - The THRIVE Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 325
- 试验地点
- 13
- 主要终点
- Primary Effectiveness Endpoint
研究概览
简要总结
Multi-center post-market, observational study to assess the long-term effectiveness and safety of the NTX100 TOMAC System for patients with Restless Legs Syndrome.
详细描述
This study will assess the NTX100 TOMAC System's long-term effectiveness and safety in real-world settings. Using a prospective, observational approach, we'll monitor individuals receiving the system as part of standard care through five study visits, collecting data on clinical outcomes, device performance, and adverse events.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The subject possesses the necessary equipment, internet/phone accessibility, and communication ability to complete electronic questionnaires and respond to electronic communications and phone calls from the research staff throughout the in-home portion of the study.
- •The subject has signed a valid, IRB-approved informed consent form, can understand the requirements of the study and instructions for device usage, and can converse in English.
- •Diagnosis of restless legs syndrome.
排除标准
- •1. The subject is unable or unwilling to comply with study requirements.
结局指标
主要结局
Primary Effectiveness Endpoint
时间窗: 1 year
Change from baseline (study entry) in IRLS total score at 1-year.
次要结局
- CGI-I score at 1-year relative to baseline(1 year)
- PGI-I Score at 1-Year Relative to Baseline(1 year)
- Change from Baseline in Frequency of RLS Symptoms (Number of Days per Week) at 1-Year(1-year)
- Change from baseline in MOS-II total score at 1-year.(1-year)
研究者
研究点 (13)
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