Multi-Center Evaluation of Clinical Outcomes of Pulse Widths <500 μsec and >1000 μsec During a Temporary Spinal Cord Stimulation Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Effect of Pulse Widths on Pain Clinical Outcomes
研究概览
简要总结
The purpose of this study is to evaluate the effect of pulse widths <500 μsec and >1000 μsec on clinical outcomes during a temporary SCS trial.
详细描述
The proposed study is a prospective, multi-center, two-arm, randomized, crossover design to be conducted at up to 10 sites. The study will enroll up to 100 subjects in order to include up to 10 subjects in the study per site. Subjects selected to participate in the trial have back and/or leg pain, have been evaluated as a candidate for SCS and have agreed to undergo a temporary SCS trial using the Algovita® system with percutaneous leads. Each subject will be followed during the trial period of approximately 7+/-2 days. The study will end when the last subject has completed the trial period and exited. The expected enrollment period for this study is approximately six months. After exit from the clinical study, subjects will continue to be followed by their physician per usual care. All device and procedure-related AEs will be collected and reported per the study protocol.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 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
- •be eligible for SCS therapy according to the Algovita® SCS system Indications for Use statement
- •be undergoing a SCS trial using Algovita® SCS system
- •sign a valid, Institutional Review Board (IRB)-approved informed consent form.
- •be 18 years of age or older when written informed consent is obtained
排除标准
- •be contraindicated for an Algovita® SCS system
- •have a cognitive impairment or exhibits any characteristic, that would limit the study candidate's ability to assess pain relief or complete study assessments
- •have a life expectancy of less than 2 years
- •be participating in another clinical study that would confound data analysis
- •have a coexisting pain condition that might confound pain ratings
- •have a significant psychiatric disorder
结局指标
主要结局
Effect of Pulse Widths on Pain Clinical Outcomes
时间窗: For 7 days following intervention
To evaluate the effect of conventional pulse widths \<500 μsec and pulse widths \>1000 μsec on clinical outcomes during temporary trial as measured by patient defined pain maps.
次要结局
- Change in Targeted Pain(For 7 days following intervention)
- Rate of AEs(For 7 days following intervention)
- Distribution of Paesthesia(For 7 days following intervention)
- Research Participant Program Preference(For 7 days following intervention)
- Research Participant Pain Relief Satisfaction(For 7 days following intervention)
- Quality of Pain Relief(For 7 days following intervention)
- ≥ 50% Pain Relief(For 7 days following intervention)
研究者
Amol Soin
Principal Investigator
Kettering Health Network