NCT04700683已完成不适用
Chronic Efficacy and Usability of Transcutaneous Electrical Nerve Stimulation in Subjects With Restless Leg Syndrome (RLS)
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 43
- 试验地点
- 3
- 主要终点
- Evaluate the clinical tolerability, usability, and patient response for the prototype device, with the intention of improving overall device performance.
研究概览
简要总结
Prospective multi-site randomized sham-controlled crossover feasibility study evaluating tolerability and efficacy of noninvasive peripheral nerve stimulation (NPNS) for patients with moderate-severe primary Restless Legs Syndrome (RLS). Response to NPNS investigational device was compared to sham control in a 2x2 crossover design such that subjects were assigned to receive 2 weeks of NPNS and 2 weeks of sham, in randomized order.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Device Feasibility
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject has moderate-severe RLS symptoms as defined by a score of 15 or greater points on IRLS.
- •RLS symptoms are primarily noticeable in the subject's lower legs and/or feet.
- •Subject reports having a medical diagnosis of primary idiopathic restless legs syndrome (RLS) or Willis-Ekbom Disorder (WED) OR Investigator has diagnosed the subject with primary idiopathic restless legs syndrome (RLS) or Willis-Ekbom Disorder (WED).
- •Subject has experienced RLS symptoms at night on 2 or more nights per week during the previous month.
- •On typical dose and schedule of RLS medication (if any), subject typically experiences RLS symptoms on 2 or more nights per week.
- •RLS symptoms are primarily in the evening and night.
- •Subject owns the necessary equipment to respond to texts, phone calls, and video calls.
- •Subject is 18 years of age or older when written informed consent is obtained.
- •Subject has signed a valid, Institutional Review Board (IRB)-approved informed consent form, can understand the requirements of the study and instructions for device usage, and can converse in English.
排除标准
- •Subject has RLS that is known to be caused by another diagnosed condition.
- •Subject has active implantable medical devices anywhere in the body (including pacemakers), or passive medical devices implanted in the leg.
- •Subject has an uncontrolled sleep disorder other than RLS that significantly interferes with their sleep as determined by the trial director or physician.
- •Subject has been diagnosed with one of the following conditions: Epilepsy or other seizure disorder, Cellulitis or open sores of the legs, Renal failure, Iron-Deficiency Anemia, Severe movement disorder symptoms (Parkinson's disease, Huntington's disease, dyskinesia, dystonia), Deep Vein Thrombosis, Stage 4-5 Chronic Kidney Disease, Multiple sclerosis, Current, active or acute or chronic infection other than viral upper respiratory tract infections, A malignancy within the past 5 years (not including basal or squamous cell skin cancer)
- •Subject is on dialysis or anticipated to start dialysis while participating in the study
- •Subject is allergic to electrode gel, polyurethane foam, or lycra.
- •Subject has severe edema in lower legs.
- •Subject has failed a nerve conduction study prescribed by a physician or has been diagnosed with severe peripheral neuropathy.
- •During Visit 1, subject cannot notice the stimulation at the maximal dose or cannot tolerate the stimulation at the minimal effective dose
- •Subject selects Statement 2 or is unable to decide which of the following two statements most closely describe their condition: Statement 1: My symptoms are best characterized by a strong or overwhelming urge to move my legs. Moving my legs often results in temporary relief of that urge. Statement 2: My symptoms are best characterized by involuntary leg spasms that happen at regular intervals. These leg spasms can wake me up in the middle of the night."
- •Subject has significantly changed medication dose or schedule of antidepressants, sleep medications, or RLS medications within the past 30 days.
- •Recent history of alcohol or recreational drug abuse (within the past 6 months).
- •Subject has received an investigational drug or device within the last 30 days or is planning to receive an investigational device during the duration of the study.
- •Subject has undergone a major surgery (excluding dental work) in the previous 30 days.
- •Subject has another medical condition that may affect validity of the study or put the subject at risk as determined by the investigator.
- •Subject is unable or unwilling to comply with study requirements
研究组 & 干预措施
Noninvasive Peripheral Nerve Stimulation
Active Comparator
NPNS device programmed to deliver active stimulation.
干预措施: Noctrix Health NPNS device v1.0 - Active (Device)
Sham control
Sham Comparator
NPNS device programmed to deliver sham stimulation.
干预措施: Noctrix Health NPNS device v1.0 - Sham (Device)
结局指标
主要结局
Evaluate the clinical tolerability, usability, and patient response for the prototype device, with the intention of improving overall device performance.
时间窗: Weeks 1-2 of each intervention
Subject satisfaction and usability questionnaire
次要结局
- Change from baseline in International Restless Legs Syndrome Study Group Rating Scale (IRLS) score at week 2(Week 2 of each intervention compared to week prior to study entry)
- Change to Summary NRS score of RLS symptom severity(Weeks 1-2 of each intervention)
- Responder rate on CGI-I scale at week 2 relative to baseline(Week 2 of each intervention compared to week prior to study entry)
- Change to Daily NRS score of RLS symptom severity(Weeks 1-2 of each intervention)
研究者
研究点 (3)
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