EVA: Evaluation of EVOKE Therapy Metrics Generated Using the Evoke System With EVA
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Evoke® therapy neural panel metrics generated by EVA™
研究概览
简要总结
The Evoke Spinal Cord Stimulator (SCS) System (Evoke® System) is an FDA-approved device that is used to manage long lasting, severe pain that is not relieved by typical medical treatments.
This research registry is being conducted to collect data from patients treated with a SCS device in order to determine how the device impacts their chronic pain condition.
Specifically, the study aims to:
- Evaluate data collected from the SCS system on how well the system is working.
- Evaluate the feasibility of programming the SCS system independently without external assistance.
- Evaluate changes in physical function, fatigue, pain interference, mood, sleep, daily activities, pain control, and overall satisfaction with the device.
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
- •Subject is not pregnant and 18 years of age or older at the time of enrollment.
- •Subject has a minimum NRS score of 6 or higher (where 10 indicates the worst imaginable pain) in primary area of pain at baseline.
- •Subject is planning to have a temporary trial with the Evoke® System to aid in the management of chronic intractable pain of the trunk and/or limbs.
- •Subject is willing to program the Evoke® System using EVA™ under the supervision of the study investigator or Qualified Health Professional.
- •Subject is being trialed with a neurostimulation system for the first time.
- •Subject is able to read and understand English.
- •Subject is capable of subjective evaluation; subject must be able to describe and rate his/her pain levels.
- •Subject is willing and capable of giving informed consent.
- •Subject is willing and able to comply with study-related requirements, procedures, and visits.
- •Subject has adequate cognitive ability to use a patient programmer and recharger as determined by the Investigator.
排除标准
- •- There are no exclusion criteria for this study.
结局指标
主要结局
Evoke® therapy neural panel metrics generated by EVA™
时间窗: At time of EVA programming and through study completion (up to 30 days)
The core neural panel metric generated by the Saluda Medical Evoke® therapy system, specifically via its EVA™ sensing technology, is the Evoked Compound Action Potential (ECAP). ECAPs are objective neurophysiological biomarkers that represent the spinal cord's electrical response to stimulation.
次要结局
- Pain Locus of Control(Up to 30 days)
- Numeric Rating Scale(Up to 30 days)
- PROMIS-29+2(Up to 30 days)
研究者
Dustin Reynolds, MD
Interventional Pain Management Specialist, Anesthesiologist
Mount Carmel Health System