Comparison of Migraine With and Without Aura in a Large Cohort: Characteristics and Response to Remote Electrical Neuromodulation (REN) Treatment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 31,715
- 试验地点
- 1
- 主要终点
- Comparison of consistent Headache Relief at 2 Hours Post-treatment between the MWA and MWoA groups
研究概览
简要总结
This is a Post-marketing, real-world evidence study investigating the safety and efficacy of the acute treatment of migraine with a Remote Electrical Neuromodulation (REN) device (Nerivio) in migraine patients with and without aura, as well as characterizing demographic and attack characteristic differences between migraine patients with and without aura.
Safety will be assessed by the number and type of device-related adverse events. Efficacy will be evaluated as a change in headache pain severity from baseline to 2 hours post-treatment. Disease characteristics will look into demographic and attack differences between patients with and without aura.
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 12 years old and above. It is a wearable device applied to the upper arm.
As part of the sign-up process for the Nerivio app, all patients accept the terms of use which specify 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 secured, personal migraine diary, which enables patients to record and track their migraines 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 the presence or absence of aura, pain level (none, mild, moderate, severe), functional disability (none, mild limitation, moderate limitation, severe limitation), presence of associated symptoms (photophobia, phonophobia, and nausea), 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 in patients with and without aura by analyzing data from patients who used the Nerivio device. The following outcomes will be assessed:
- Migraine clinical characteristics - Headache pain severity, functional disability and presence of associated symptoms at treatment baseline.
- Consistent efficacy - Pain relief, freedom from pain, functional disability relief, return to normal function (no disability) and freedom from associated symptoms at 2 hours post-treatment relative to baseline in at least 50% of the treatments.
- Safety - Rate of serious adverse events, and device-related adverse events in the study's period.
Together, these objectives provide a comprehensive evaluation of the effect of REN as a treatment for migraine with or without aura.
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
- 8 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Users aged 8 years old and above
- •Users who treated their migraine attacks with the Nerivio device at least twice
- •Users who prospectively reported the presence of aura in at least two treatment reports (reporting at least twice having aura) , OR:
- •Users who prospectively reported the absence of aura in all of their reports, with at least two reports
排除标准
- •Users who prospectively reported having aura only once
结局指标
主要结局
Comparison of consistent Headache Relief at 2 Hours Post-treatment between the MWA and MWoA groups
时间窗: 2 hours
The difference between the MWA and MWoA groups in the proportion of subjects reporting headache relief at 2 hours post-treatment in at least 50% of all their treatments. Headache relief is defined as an improvement from severe or moderate pain to mild or no pain.
Comparison of Headache Severity at treatment baseline (T=0h) between the MWA and MWoA groups
时间窗: 0 hours (at baseline)
The difference between the MWA and MWoA groups in the proportion of subjects reporting severe/moderate headache pain in at least 50% of their attacks.
次要结局
- Comparison of consistent Pain Freedom at 2 Hours Post-treatment between the MWA and MWoA groups(2 hours)
- Comparison of Functional Disability at treatment baseline (T=0h) between the MWA and MWoA groups(0 hours (at baseline))
- Comparison of Photophobia, Phonophobia and Nausea/vomiting presence at treatment baseline (T=0h) between the MWA and MWoA groups(0 hours (at baseline))
- Comparison of Consistent Functional Disability Relief at 2 Hours Post-treatment between the MWA and MWoA groups(2 hours)
- Comparison of Consistent Functional Disability Freedom at 2 Hours Post-treatment between the MWA and MWoA groups(2 hours)
- Comparison of Associated Symptoms Freedom at 2 Hours Post-treatment between the MWA and MWoA groups(2 hours)
- Device Related Adverse Events(up to 30 months)