Real-World Analysis of Remote Electrical Neuromodulation (REN) for the Acute Treatment of Migraine in Adolescence
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,629
- 试验地点
- 2
- 主要终点
- Consistent Pain Relief at 2 Hours Post-treatment
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. Data analysis concerning the REN treatment efficacy in terms of pain and functional disability as a standalone treatment or in combination with other medications will be performed.
详细描述
The REN device (Nerivio by Theranica, Israel) is a neuromodulation device approved by the FDA for acute treatment of migraine in patients of 12 years old and above (1-4). 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 of 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.
Post-marketing surveillance is designed to assess the efficacy and safety 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.
Recently, Real World Evidence (RWE) papers of Nerivio usage in adults were published (5-6). these papers demonstrated the safety and efficacy of the Nerivio device in a large-scale population using the accumulated data gathered by diary within the Nerivio app.
This post-marketing RWE study investigates the efficacy of the Nerivio treatment using the following outcomes:
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
- •- Age between 12-18 years
- •- REN user across the United States who created Nerivio account on January 1st, 2021 or later.
- •- Had at least two evaluable treatments with the Nerivio device
排除标准
- •(1) - Treatments shorter than 20 minutes
结局指标
主要结局
Consistent Pain Relief at 2 Hours Post-treatment
时间窗: 2 hours post treatment, up to 16 months from the 1st treatment
The proportion of subjects reporting pain relief at 2 hours post-treatment without the use of rescue medication in at least 50% of all their treatments. Pain relief is defined as an improvement from severe or moderate pain to mild or no pain, Pain level is reported using a 4-point Likert scale (0 - No pain, 1 - Mild pain, 2 - Moderate pain,3- Severe pain)
次要结局
- Consistent Pain Freedom at 2 Hours Post-treatment(2 hours post treatment, up to 16 months from the 1st treatment)
- Consistent Usage of Migraine Abortive (Rescue) Medications(2 hours post treatment, up to 16 months from the 1st treatment)
- Consistent Functional Disability Relief at 2 Hours Post-treatment(2 hours post treatment, up to 16 months from the 1st treatment)
- Consistent Functional Disability Disappearance at 2 Hours Post-treatment(2 hours post treatment, up to 16 months from the 1st treatment)