Remote Electrical Neuromodulation (REN) Wearable Device for Adolescents with Migraine: Real World Study of High-Frequency Users Suggest Preventive Effects
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 83
- 试验地点
- 1
- 主要终点
- Reduction in Mean Monthly Migraine Treatment Days
研究概览
简要总结
This is a post-marketing study investigating the safety and efficacy of the REN device (Nerivio by Theranica, ISRAEL) in adolescents with migraine. The data analysis will test the ability of Frequent use of REN for the acute treatment of migraine to reduce the number of monthly migraine days in subsequent months, suggesting potential preventive benefits.
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 of 12 years old and above. It is a wearable device applied to the upper arm. It stimulates C and Aδ noxious fibers using a modulated, symmetrical, biphasic, square pulse with a pulse width of 400 μs, modulated frequency of 100-120 Hz, and up to 40 mA output current which the patient can adjust. 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 to the Nerivio app, all patients accept the terms of use which specify that providing personal information is done by 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 pain level (none, mild, moderate, severe), functional disability (No limitation, Some 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 potential of high usage of Nerivio for the acute treatment of migraine on migraine prevention, using the following outcomes:
-
- reduction in mean monthly migraine treatment days (MMTD),
-
- acute treatment efficacy measured 2 h post-treatment
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- improve in functional disability
-
- Device safety
Together, these objectives may provide a comprehensive evaluation of the impact of the high usage of Nerivio for acute treatment as a migraine preventive tool in the migraine adolescent population.
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 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patient age is 12 Years to 18 Years
- •Patient is using the Nerivio device for acute treatment of migraine
- •Patient treated at least 10 treatments in his first month of using Nerivio and at least 3 treatments in each of the two consecutive months (months 2 and 3
排除标准
- •Treatments shorter than 30 minutes
结局指标
主要结局
Reduction in Mean Monthly Migraine Treatment Days
时间窗: 3 months
Mean number of migraine treatment days per month during 3 consecutive months, comparing each month to the first month. A migraine treatment day is defined as a day in which a patient treated their migraine with REN.
次要结局
- Consistent Functional Disability disappearance at 2 Hours Post-treatment(2 hours)
- Device Related Adverse Events(3 months)
- Consistent Headache Relief at 2 Hours Post-treatment(2 hours)
- Consistent Functional Disability Relief at 2 Hours Post-treatment(2 hours)
- Consistent Freedom From Headache at 2 Hours Post-treatment(2 hours)