NCT02950831已完成不适用
Objective Assessment of Activity and Sleep Quality In Burst Spinal Cord Stimulation
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
- 27
- 试验地点
- 6
- 主要终点
- Change in Sleep Quality
研究概览
简要总结
The purpose of this study is to assess feasibility of using wearable sensors to capture objective assessments of patient's activity and sleep quality during the spinal cord stimulation (SCS) treatment continuum.
详细描述
Eligible patients will undergo standard clinical care using BurstDR SCS and will be asked to wear a wrist worn accelerometer for a baseline period, during SCS trial and for 3 months after activation of the SCS stimulation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
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 is able to provide informed consent to participate in the study;
- •Subject is 18 years of age or older;
- •Subject has failed to respond to at least 6 months of conventional treatment including pharmacological treatment, physical therapy, epidural injections and/or radiofrequency therapy;
- •Subjects with the diagnosis of failed back surgery syndrome or chronic intractable trunk and/or lower limb pain and are eligible for a SCS trial;
- •Subjects have an average trunk pain VAS score of at least 6.0 out of 10.0, and/or lower limb pain VAS score of at least 6.0 out of 10.0;
- •Subject is on stable pain medications, as determined by the Investigator, for at least 28 days prior to enrolling in this study, and is willing to stay on those medications with no dose adjustments until activation of the permanently implanted SCS device;
- •Subject's medical record has been evaluated by the Investigator to ensure that the subject is a good candidate for a neurostimulation system;
- •Subject is willing to cooperate with the study requirements including compliance with the regimen and completion of all office visits;
- •Subject agrees to wear the wearable sensor for the duration of the study;
- •Female candidates of child-bearing potential agree to commit to the use of an effective method of contraception (including but not limited to sterilization, barrier devices, oral contraceptives, intrauterine devices (IUDs), condoms, rhythm method, or abstinence) for the duration of the study
排除标准
- •Subject is currently participating in a clinical investigation that includes an active treatment arm;
- •Subject has been implanted with or participated in a trial period for a neurostimulation system;
- •Non- ambulatory subjects who are not expected to become ambulatory after receiving neurostimulation;
- •Subject diagnosed with fibromyalgia or chronic fatigue;
- •Subject has an infusion pump;
- •Subject has evidence of an active disruptive psychological or psychiatric disorder as determined as per standard of care;
- •Subject has a current diagnosis of a coagulation disorder, bleeding diathesis, progressive peripheral vascular disease or uncontrolled diabetes mellitus;
- •Subject has a current diagnosis of a progressive neurological disease as determined by the Investigator;
- •Subject is immunocompromised;
- •Subjects with concurrent clinically significant or disabling chronic pain problem that requires additional treatment;
- •Subject has an existing medical condition that is likely to require repetitive MRI evaluation in the future (i.e. epilepsy, stroke, multiple sclerosis, acoustic neuroma, tumor);
- •Subject has history of cancer requiring active treatment in the last 12 months;
- •Subject has an existing medical condition that is likely to require the use of diathermy in the future;
- •Subject has documented history of allergic response to titanium or silicone;
- •Subject has a documented history of substance abuse (narcotics, alcohol, etc.) or substance dependency in the 6 months prior to baseline data collection;
- •Female candidates of child bearing potential that are pregnant (confirmed by positive urine/blood pregnancy test)
研究组 & 干预措施
Activity and sleep quality recording
Experimental
Patients will receive a wrist worn accelerometer and accelerometry will be used to monitor physical activity and sleep quality during standard BurstDR Spinal Cord Stimulation clinical treatment
干预措施: Accelerometry (Other)
结局指标
主要结局
Change in Sleep Quality
时间窗: between baseline and the end of spinal cord stimulation trial period (average of 1 month)
Recording performed with wrist worn accelerometer. Sleep duration was calculated based on accelerometry data.
Change in Activity Levels
时间窗: between baseline and the end of spinal cord stimulation trial period (average of 1 month)
Recording performed with wrist worn accelerometer. Medium to Vigorous Physical Activity (MVPA) were calculated based on accelerometry data. MVPA value represents the hours of medium to vigorous physical activity in a day.
次要结局
- Change in Visual Analog Scale (VAS) for Pain(between baseline and 3 month post permanent spinal cord stimulator activation followup)
- Change in European Quality of Life 5 Dimensions (EQ-5D)(between baseline and 3 month post permanent spinal cord stimulator activation followup)
- Change in Oswestry Disability Index (ODI)(between baseline and 3 month post permanent spinal cord stimulator activation followup)
- Change in Activity Levels(between baseline and 3 month post permanent spinal cord stimulator activation followup)
- Change in Sleep Quality(between baseline and 3 month post permanent spinal cord stimulator activation followup)
研究者
研究点 (6)
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