NCT05214963已完成不适用
Exploratory Clinical Study to Assess Tolerability, Safety, and Response to Non-invasive Peripheral Nerve Stimulation (NPNS) in Medication-naïve and Medication-refractory Restless Legs Syndrome (RLS) Patients
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
- 58
- 试验地点
- 3
- 主要终点
- Actigraphy-Based Sleep Efficiency
研究概览
简要总结
Prospective multi-site randomized sham-controlled study evaluating tolerability and efficacy of noninvasive peripheral nerve stimulation (NPNS) for patients with moderate-severe primary Restless Legs Syndrome (RLS) who are either medication-naive or medication-refractory.
详细描述
The study consists of a series of two 2-week phases:
Phase 1: Baseline evaluation of RLS and sleep Phase 2: Prospective, single-blinded, 1:1 randomized evaluation of response to NPNS treatment (Active treatment: Sham control)
Additionally, subjects will have the option to consent to a third phase, which includes overnight polysomnography (PSG) evaluation of sleep with Active treatment and with no treatment (baseline), in randomized order.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
Single-blind [Participant]
入排标准
- 年龄范围
- 22 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject has received a medical diagnosis of primary restless legs syndrome (RLS).
- •Subject is either medication-naïve or medication-refractory.
- •Subject has moderate-severe RLS symptoms as defined by a score of 15 or greater points on IRLS (International Restless Legs Syndrome Study Group Rating Scale) over the week prior to study entry.
- •RLS symptoms interfered with sleep on at least 3 nights per week during the month prior to study entry.
- •RLS symptoms are most significant in the subject's lower legs and/or feet.
- •RLS symptoms are most significant after 6pm.
- •Subject agrees to not change dosage or schedule of any medications that are known to impact RLS symptoms during the study, including RLS medications, antidepressants, sleep medications, or sedative antihistamines.
- •Subject agrees to not make major lifestyle changes during the study that would significantly affect bedtime, such as major changes to diet, exercise, or career.
- •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.
- •Subject is ≥ 22 and ≤ 89 years of age when written informed consent is obtained.
- •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.
排除标准
- •Subject has RLS that is known to be caused by another diagnosed condition (i.e. secondary RLS).
- •Subject is taking an unstable or inconsistent dose or schedule of medication that is likely to impact RLS symptoms, such as antidepressants, sleep medications, or sedative antihistamines or has changed dosage within the past 30 days.
- •Subject has changed dose and schedule of RLS medications within the month prior to study entry or is otherwise on an inconsistent dose or schedule of RLS medications.
- •Subject has prior experience with Noctrix Health NPNS devices.
- •Subject was misdiagnosed with RLS, as determined by the investigator (e.g. actual diagnosis of PLMD, arthritis, leg spasms or neuropathy without comorbid RLS).
- •Subject has a primary sleep disorder other than RLS that significantly interferes with sleep at the present time (e.g. obstructive sleep apnea stably controlled via CPAP would not be an exclusion).
- •Subject has active medical device implant anywhere in the body (including but not limited to pacemakers, spinal cord stimulators, deep brain stimulators) or metal implant at the site of study device electrode application.
- •Subject has severe peripheral neuropathy affecting the lower legs and/or subject has neuropathy and is unable to clearly distinguish between symptoms of neuropathy and symptoms of RLS.
- •Subject has been diagnosed with one of the following conditions:
- •Epilepsy or other seizure disorder
- •Current, active or acute or chronic infection other than common cold
- •A malignancy within the past 5 years (not including basal or squamous cell skin cancer)
- •Stage 4-5 chronic kidney disease or renal failure
- •Severe movement disorder symptoms (Parkinson's disease, Huntington's disease, dyskinesia, dystonia)
- •Deep vein thrombosis
- •Multiple sclerosis
- •Subject has moderate or severe cognitive disorder or mental illness.
- •Subject has current diagnosis of iron-deficient anemia or history of iron-deficient anemia within the past year.
- •Subject has known allergy to device materials or severe previous reaction to medical adhesives or bandages.
- •Subject has severe edema affecting lower legs.
- •Subject has any of the following at or near the location of device application.
- •Acute injury
- •Cellulitis
- •Open sores
- •Other skin condition
- •Subject is on dialysis or anticipated to start dialysis while participating in the study
- •During the NTX100 calibration process, which is identical for subjects in the active and sham arms, subject reports not feeling stimulation sensations up to an intensity of 30mA, the subject finds stimulation intensities less than 15 mA to be uncomfortable or distracting, or the device does not properly fit the subject.
- •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 is pregnant or trying to become pregnant.
- •Subject has undergone a major surgery (excluding dental work) in the previous 30 days.
- •Subject is unable or unwilling to comply with study requirements.
- •Subject has another medical condition that may put the subject at risk as determined by the investigator.
- •Subject has another medical condition that may affect validity of the study as determined by the investigator.
研究组 & 干预措施
Active neurostimulation
Active Comparator
Noninvasive peripheral nerve stimulation device programmed to deliver active stimulation
干预措施: NTX100 Neuromodulation System - Active (Device)
Sham neurostimulation
Sham Comparator
Noninvasive peripheral nerve stimulation device programmed to deliver non-therapeutic (sham) stimulation
干预措施: NTX100 Neuromodulation System - Sham (Device)
结局指标
主要结局
Actigraphy-Based Sleep Efficiency
时间窗: 1 week
The ratio of wake after sleep onset to total sleep time, as measured by actigraphy
Actigraphy-Based Total Sleep Time
时间窗: 1 week
Total sleep duration, as measured by actigraphy
Tolerability based on Withdrawal Rate
时间窗: 2 weeks
Percentage of subjects who withdraw from study citing lack of tolerability of the study device as the primary reason for withdrawal
次要结局
- Polysomnography-Based Total Sleep Time(1 night)
- Frequency of Device Usage(2 weeks)
- Grade 2 or higher device-related adverse events(2 weeks)
- Grade 3 or higher device-related adverse events(2 weeks)
- Polysomnography-Based Sleep Efficiency(1 night)
- Polysomnography-Based Percentage of REM Sleep(1 night)
- International Restless Legs Syndrome Study Group Rating Scale (IRLS) score(1 week)
- Patient Global Impressions of Improvement Responder Rate(1 week)
- Polysomnography-Based Percentage of Stage 3 Sleep(1 night)
研究者
研究点 (3)
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