Spinal Cord Stimulation Research Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 100
- 试验地点
- 9
- 主要终点
- Numeric Pain Rating Scale (NPRS) - Cohort 1
研究概览
简要总结
To characterize the effects of stimulation parameters on pain relief and other cohort specific outcomes.
详细描述
This post market study will measure the following:
- Numeric Pain Rating Scale
- Satisfaction and Stimulation Assessment
- Stimulation feedback
- Stimulation parameters
- Anatomical locations of active contacts
- Stimulation thresholds
- Location of paresthesia
- Oswestry Disability Index
- European Quality of Life 5-Dimensions
- To characterize non-invasive health monitoring data
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •22 years of age or older
- •Implanted with a Medtronic rechargeable neurostimulation system, for a labeled indication, for at least 1 month and expected longevity of neurostimulator is at least 5 months
- •Willing and able to provide signed and dated informed consent
- •Capable of comprehending and consenting in English
- •Willing and able to comply with all study procedures, including diary completion, and visits
- •Able to differentiate between pain associated with the indication for SCS implant and other types of pain
排除标准
- •Implanted with neurostimulation system for an off-label indication
- •Currently enrolled or planning to enroll in an interventional clinical study that could potentially confound the study results
- •If female, pregnant or is of child-bearing potential and unwilling to use a medically acceptable form of birth control during the study
- •Has untreated major psychiatric comorbidity
- •Has a non-rechargeable neurostimulator where the battery longevity is not able to be estimated with the battery longevity calculator
研究组 & 干预措施
Cohort 1: Low Energy - Continuous
Subjects will be programmed to a specific frequency with a long pulse width at various amplitudes
干预措施: Spinal Cord Stimulation (Device)
Cohort 2: Interleaving
Determine effects of delivering ping pulses combined with governed pulses while using separate sets of electrodes
干预措施: Spinal Cord Stimulation (Device)
Cohort 4: Low Energy Cycling 1
Effects of decreased pulse widths with increased frequency - with and without cycling parameters
干预措施: Spinal Cord Stimulation (Device)
Cohort 3: Cycling Evolve
Subjects will be programmed to high dose (HD) stimulation with various cycling parameters
干预措施: Spinal Cord Stimulation (Device)
Cohort 5: Low Energy Cycling 2
Effects of decreased pulse widths with increased frequency - with and without cycling parameters (different pulse widths and frequencies than Cohort 4)
干预措施: Spinal Cord Stimulation (Device)
Cohort 6: Differential Targeted Multiplexed-Low Energy Spinal Cord Stimulation (DTM-LE SCS)
Effects of decreased frequency and therapy cycling parameters
干预措施: Spinal Cord Stimulation (Device)
Cohort 7: Super Cycle
Effects of longer cycle duration
干预措施: Spinal Cord Stimulation (Device)
Cohort 8: Differential Targeted Multiplexed (DTM) for Neuro Sense (NS)
Effects of integrating Neuro Sense into DTM programming
干预措施: Spinal Cord Stimulation (Device)
Cohort 9: Diabetic Peripheral Neuropathy (DPN) Flow
Characteristics of vital signs in DPN participants
干预措施: Spinal Cord Stimulation (Device)
结局指标
主要结局
Numeric Pain Rating Scale (NPRS) - Cohort 1
时间窗: Up to 5 months
To characterize the effect of different programmed settings on pain relief. The NPRS will be recorded once or daily over a period of time, where the subjects will rate their pain on a 11-point numeric rating scale of 0 to 10, with 0 representing 'No Pain' and 10 representing 'Worst pain imaginable'. The average overall NPRS pain score prior to the scheduled visit will be used for analysis.
Numeric Pain Rating Scale (NPRS) - Cohort 2
时间窗: Up to 2 months
To characterize the effect of different programmed settings on pain relief. The NPRS will be recorded once or daily over a period of time, where the subjects will rate their pain on a 11-point numeric rating scale of 0 to 10, with 0 representing 'No Pain' and 10 representing 'Worst pain imaginable'. The average overall NPRS pain score prior to the scheduled visit will be used for analysis.
Numeric Pain Rating Scale (NPRS) - Cohort 3
时间窗: Up to 3 months
To characterize the effect of different programmed settings on pain relief. The NPRS will be recorded once or daily over a period of time, where the subjects will rate their pain on a 11-point numeric rating scale of 0 to 10, with 0 representing 'No Pain' and 10 representing 'Worst pain imaginable'. The average overall NPRS pain score prior to the scheduled visit will be used for analysis.
Numeric Pain Rating Scale (NPRS) - Cohort 4
时间窗: Up to 5 months
To characterize the effect of different programmed settings on pain relief. The NPRS will be recorded once or daily over a period of time, where the subjects will rate their pain on a 11-point numeric rating scale of 0 to 10, with 0 representing 'No Pain' and 10 representing 'Worst pain imaginable'. The average overall NPRS pain score prior to the scheduled visit will be used for analysis.
Numeric Pain Rating Scale - Cohort 5
时间窗: Up to 5 months
To characterize the effect of different programmed settings on pain relief. The NPRS will be recorded once or daily over a period of time, where the subjects will rate their pain on a 11-point numeric rating scale of 0 to 10, with 0 representing 'No Pain' and 10 representing 'Worst pain imaginable'. The average overall NPRS pain score prior to the scheduled visit will be used for analysis.
Numeric Pain Rating Scale (NPRS) - Cohort 6
时间窗: Up to 7 months
To characterize the effect of different programmed settings on pain relief. The NPRS will be recorded once or daily over a period of time, where the subjects will rate their pain on a 11-point numeric rating scale of 0 to 10, with 0 representing 'No Pain' and 10 representing 'Worst pain imaginable'. The average overall NPRS pain score prior to the scheduled visit will be used for analysis.
Numeric Pain Rating Scale (NPRS) - Cohort 7
时间窗: Up to 8 months
To characterize the effect of different programmed settings on pain relief. The NPRS will be recorded once or daily over a period of time, where the subjects will rate their pain on a 11-point numeric rating scale of 0 to 10, with 0 representing 'No Pain' and 10 representing 'Worst pain imaginable'. The average overall NPRS pain score prior to the scheduled visit will be used for analysis.
Numeric Pain Rating Scale (NPRS) - Cohort 8
时间窗: Up to 0.5 months
To characterize the effect of different programmed settings on pain relief. The NPRS will be recorded once or daily over a period of time, where the subjects will rate their pain on a 11-point numeric rating scale of 0 to 10, with 0 representing 'No Pain' and 10 representing 'Worst pain imaginable'. The average overall NPRS pain score prior to the scheduled visit will be used for analysis.
Numeric Pain Rating Scale at Enrollment (NPRS) - Cohort 9
时间窗: Up to 1 month
To characterize the effect of different programmed settings on pain relief. The NPRS will be recorded once or daily over a period of time, where the subjects will rate their pain on a 11-point numeric rating scale of 0 to 10, with 0 representing 'No Pain' and 10 representing 'Worst pain imaginable'. The average overall NPRS pain score prior to the scheduled visit will be used for analysis.
次要结局
未报告次要终点