Real-World Evidence (RWE) Data Analysis of 1-year Safety, Consistent Utilization, and Consistent Efficacy of Remote Electrical Neuromodulation (REN)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 409
- 试验地点
- 2
- 主要终点
- Device Related Adverse Events
研究概览
简要总结
This is a Post-marketing study investigating the long-term safety, utilization, and efficacy of REN during 12 consecutive months of using Nerivio in migraine patients.
Safety will be assessed by the number and type of adverse events. Utilization will be measured by the number of monthly treatments. Efficacy will be evaluated as a change in headache pain severity and functional disability from baseline to 2 hours post-treatment in at least 50% of the treatments.
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. 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 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 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 (None, Mild limitation, Moderate limitation, Severe limitation), and an indication of which medications, if any, were taken within that 2-hour time window.
Post-marketing surveillance is designed to assess the safety, utilization, and efficacy in larger and more diverse populations and in various real-world environments and situations. As a digital therapeutic device (i.e., electroceutical), the REN device enables prospective collection of electronic patient-reported outcomes in real-world clinical practice.
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 12 months (1 year): the following outcome will be assessed:
-
- Safety - all adverse events that were reported within the study's period
-
- Utilization - the number of Nerivio treatments per month
-
- Efficacy - pain relief, freedom from pain, improvement in functional disability, and return to normal function (no disability) at 2 hours post-treatment
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 99 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •REN users across the United States who created Nerivio accounts on October 1st, 2019, and later.
- •Had at least one Nerivio treatment per month for 12 consecutive months
排除标准
- •Treatments shorter than 30 minutes
结局指标
主要结局
Device Related Adverse Events
时间窗: 12 months
Incidence of device-related adverse events reported by subjects
次要结局
- Consistent Functional Disability disappearance at 2 Hours Post-treatment(2 hours)
- Long Term Utilization of Nerivio(12 months)
- Consistent Freedom From Headache at 2 Hours Post-treatment(2 hours)
- Consistent Headache Relief at 2 Hours Post-treatment(2 hours)
- Consistent Functional Disability Relief at 2 Hours Post-treatment(2 hours)