Study to Evaluate Neuromodulation Subject Experience With Contemporary Spinal Cord Stimulation (SCS) Modalities for Chronic Pain (SENSE SCS Clinical Study)
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 91
- 试验地点
- 10
- 主要终点
- Percentage of surveys completed from Baseline through the SCS Trial Period in the Pilot Phase Cohort.
研究概览
简要总结
Medtronic, Inc. is sponsoring the SENSE SCS clinical study, a prospective, multi-center, post-market, non-randomized, observational study with a hybrid decentralized model of execution, utilizing a mobile application for the collection of patient reported outcomes (PROs). The purpose of the study is to evaluate workflow of a mobile application for collection of PROs and to gather data on patient experience with spinal cord stimulation therapy.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pilot Phase Inclusion Criteria:
- •18 years of age or older
- •A clinical decision was made for the patient to receive a commercial Medtronic SCS system (trial and implant) limited to the components for an on-label indication prior to enrollment in the study. NOTE: Vectris™ SureScan™ MRI 1x8 subcompact and Specify™SureScan™ MRI 2x8 leads are not eligible system components
- •Able to differentiate between pain associated with the indication for SCS implant and other types of pain, as determined by the Investigator or designee
- •Willing and able to use a personal smart phone for study surveys. NOTE: All subjects participating in the study must be willing to download the InsightPro™ clinical trial app and maintain current software updates on their own smart phone.
- •Willing and able to provide signed and dated informed consent in English
- •Willing and able to comply with all study procedures and visits
- •Pilot Phase
排除标准
- •Any active implantable neuromodulation device or system (e.g., Peripheral Nerve Stimulation, Sacral Neuromodulation)
- •Currently participating, or plans to participate, in another investigational study or has a planned major medical procedure that may interfere with study procedures or confound study results, as determined by the Investigator or designee, unless documented pre-approval is provided by the sponsor
- •Major untreated or refractory psychiatric comorbidity or other progressive disease (e.g., neurodegenerative disease, heart failure, cancer) that may confound study results, as determined by the Investigator or designee
- •Serious drug-related behavioral issues (e.g., alcohol dependency, illegal substance abuse), as determined by the Investigator or designee
- •Pregnant or planning on becoming pregnant
- •Involved in an injury claim under current litigation, beneficiary of an injury claim, or receiving worker's compensation
- •Patients with buried lead trials/implants will be excluded from this study
研究组 & 干预措施
Pilot Phase Cohort
干预措施: Commercially available neurostimulation systems (Device)
Data at Scale Phase Cohort
干预措施: Commercially available neurostimulation systems (Device)
结局指标
主要结局
Percentage of surveys completed from Baseline through the SCS Trial Period in the Pilot Phase Cohort.
时间窗: Up to 28 days
The percentage of surveys with complete data collected via the InsightPro™ clinical trial app from Baseline through the SCS Trial Period, calculated as the number of surveys with complete data divided by the total number of expected surveys within the Pilot Phase Cohort, expressed as a percentage.
Rating on the 7-point scale of Patient Global Impression of Change (PGIC) at Month 3 in the Data at Scale Phase Cohort
时间窗: Month 3
PGIC is a single question asking the subject to rate their improvement in pain condition on a 7-point scale from 1 (Very Much Improved) to 7 (Very Much Worse)
次要结局
未报告次要终点