Remote Electrical Neuromodulation for Acute Procedural Pain in Chronic Migraine Patients Receiving onabotulinumtoxinA
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- Mayo Clinic
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Change in Pain Intensity Measured by Visual Analog Scale (VAS)
研究概览
简要总结
The purpose of this study is to assess the effectiveness of using remote electrical neuromodulation, using the Nerivio ® device, to relieve pain associated with receiving onabotulinumtoxinA (Botox) injections for chronic migraine prevention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Meet the criteria for 1.3 chronic migraine based on ICHD3 criteria.
- •Currently receiving onabotulinumtoxinA per PREEMPT protocol for the treatment of chronic migraine.
- •Patient is willing and able to comply with the protocol to the satisfaction of the investigator.
- •Patient has the capacity to provide written, informed consent for themselves.
排除标准
- •Participants with an active implanted electrical and/or neurostimulator device (e.g., cardiac pacemaker, cochlear implant).
- •Participants with congestive heart failure (CHF), severe cardiac or cerebrovascular disease.
- •Participants with uncontrolled epilepsy.
- •Pregnant, trying to get pregnant or breastfeeding female participants.
- •Subjects participating in any other interventional clinical study.
- •Participants with other significant pain, medical or psychological problems that in the opinion of the investigator may confound the study assessments.
- •Participants who have previous experience with the device.
- •Patients with cranial deformities, prior cranial surgeries with violation of the calvarium, or shunt placement.
- •Patients receiving concurrent nerve blocks or trigger point injections within the same visit
结局指标
主要结局
Change in Pain Intensity Measured by Visual Analog Scale (VAS)
时间窗: Baseline, Week 12, Week 24
Measured by VAS values reported by participants using the 100-mm Visual Analogue Scale (VAS). The VAS line will be 100 mm long with no intermediate delineations. Each end will be marked with "no pain" on the left, and "worst possible pain" on the right. Participants will identify their pain level by indicating a point on the line between each end. That point will be measured from the "No pain" end, and the number of millimeters will be reported as the pain score. Scores can range from 0 to 100, with higher score indicating worse pain.
次要结局
- Adverse Events(24 weeks)
- Presence of Post-procedural Headache(Baseline, Week 12, Week 24)
- Adverse Events(24 weeks)
研究者
Amaal J. Starling, M.D.
Principal Investigator
Mayo Clinic