Real-World Evidence (RWE) Data Analysis of 3-year Usage of Nerivio, a Remote Electrical Neurostimulation (REN) Device In Patients With Migraine
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 244
- 试验地点
- 1
- 主要终点
- Long Term Lack of Tachyphylaxis
研究概览
简要总结
This is a post-marketing real-world evidence study investigates long-term treatment with the Remote Electrical Neuromodulation (REN) wearable Nerivio device over 3 consecutive years in patients with migraine.
详细描述
The REN device (Nerivio by Theranica, Israel) is a neuromodulation device approved by the FDA for acute and/or preventive treatment of migraine in patients 8 years old and above. It is a wearable device applied to the upper arm. It stimulates C and Aδ noxious fibers. The REN device is operated by a designated app that is downloaded to the user's phone prior first use of the Nerivio device.
As part of the sign-up process for the Nerivio app, all patients accept the terms of use which specifies that providing personal information is done on their own free will and that their de-identified data may be used for research purposes. Users are not obligated to provide personal information and could treat without providing any feedback. The app includes a secure, personal migraine diary, which enables patients to record and track their migraine and other headaches. At the beginning of each treatment, and again 2 hours after the start of treatment, patients are prompted to record their symptoms, including pain level (none, mild, moderate, severe), functional disability (none, mild limitation, moderate limitation, severe limitation), and an indication of which medications, if any, were taken within that 2-hour time window.
This post-marketing RWE study investigates the safety and efficacy of the Nerivio treatment by analyzing data of patients who used the Nerivio device for consecutive 3 years: the following outcome will be assessed:
Primary endpoint:
- Lack of Tachyphylaxis - No clinically meaningful change in treatment intensity between years.
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
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Users who began treating with the REN wearable device between December 2019 and September
- •Users who treated migraine attacks consecutively for 3 years, with at least 9 months per year
- •Users with at least one treatment recorded in each of the counted months.
排除标准
- 未提供
结局指标
主要结局
Long Term Lack of Tachyphylaxis
时间窗: 3 Years
No clinically meaningful change in treatment intensity between the years (defined as change of less than 2.5 of treatment intensity units between consecutive years).
次要结局
- Long Term Consistent Pain Relief at 2 Hours Post-treatment(3 Years)
- Long Term Consistent Pain Freedom at 2 Hours Post-treatment(3 Years)
- Long Term Consistent Functional Disability Relief at 2 Hours Post-treatment(3 Years)
- Long Term Consistent Functional Disability disappearance at 2 Hours Post-treatment(3 Years)
- Long Term Consistent Freedom from Associated Symptoms at 2-Hours Post-treatment(3 years)
- Long Term Utilization of Nerivio(3 Years)
- Device Related Adverse Events(3 Years)