NCT04618471进行中（未招募）不适用
Study to Demonstrate the Value of Paresthesia-Free Fast-Acting Subperception (FAST) and Other SCS Therapies Using WaveWriter™ Spinal Cord Stimulator Systems in the Treatment of Chronic Pain
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 177
- 试验地点
- 20
- 主要终点
- Targeted Pain Responder Rate
研究概览
简要总结
Study to evaluate the effectiveness of FAST-SCS (fast-acting paresthesia-free therapy) and additional SCS therapy options in patients with chronic pain using Boston Scientific WaveWriter SCS Systems.
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
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chronic pain (predominantly neuropathic) of the trunk and/or limbs for at least 6 months with back pain greater or equal to leg pain.
- •22 years of age or older when written informed consent is obtained
- •Able to independently read and complete all questionnaires and assessments provided in English
- •Signed a valid, IRB-approved informed consent form (ICF) provided in English
排除标准
- •Any pain-related diagnosis or medical/psychological condition or external factors that, in the clinician's best judgment, might confound reporting of study outcomes
- •Significant cognitive impairment that, in the opinion of the Investigator, would reasonably be expected to impair the study candidate's ability to participate in the study
- •Breast-feeding or planning to get pregnant during the course of the study or not using adequate contraception
- •Participating, or intends to participate, in another clinical trial that may influence the data that will be collected for this study
研究组 & 干预措施
WaveWriter Settings
Experimental
干预措施: Boston Scientific WaveWriter SCS System (Device)
结局指标
主要结局
Targeted Pain Responder Rate
时间窗: 3 months post-activation
Proportion of subjects with 50% or greater reduction from Baseline Visit in average targeted pain intensity at 3 months post-activation
次要结局
未报告次要终点
研究者
研究点 (20)
Loading locations...
相似试验
终止
不适用
Paresthesia Free Spinal Cord Stimulation (PF-SCS)SCSChronic PainNCT03670147Massachusetts General Hospital10
尚未招募
4 期
Early Pharmacological Treatment of Acute Spasticity After Spinal Cord InjuryTraumatic Spinal Cord InjuryNCT06564714Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal55
已完成
不适用
Efficacy and Cost-effectiveness of Spasticity Treatment With Multifocal TENSSpasticityCerebral PalsyStrokeNCT02261142Linkoeping University31
Unknown
不适用
Motor Cortex Stimulation for Chronic Neuropathic PainNeuropathic PainFacial PainPost-stroke PainBrachial Plexus AvulsionPhantom Limb Pain of the Upper ExtremitiesNCT01554332Abbott Medical Devices38
已完成
不适用
Functional Outcome and Analgesia in TKA: Radiofrequency vs Continuous Adductor Canal BlockOsteoarthritis, KneeNCT02680392McGill University Health Centre/Research Institute of the McGill University Health Centre40