A Prospective, Single Arm, Open Label Post Market Study Assessing the Safety and Efficacy of Nerivio for the Treatment of Migraine in Children Under the Age of 12
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 293
- 试验地点
- 2
- 主要终点
- Rate of Device Related Adverse Events
研究概览
简要总结
Migraine is a prevalent neurological disorder that severely impacts both children and adolescents, causing significant disability. Remote Electrical Neuromodulation (REN) is a nonpharmacological, prescribed, wearable device, FDA-cleared for acute and/or preventive treatment of migraine with or without aura in patients 12 years or older. Multiple studies have shown that REN has high safety, tolerability, and efficacy in adults and adolescents. This study aims to evaluate REN's real-world safety and efficacy in pre-adolescents, 6-11 years old.
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 smartphone application 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 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 secure, personal migraine diary, which enables patients to record and track their migraines attacks 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.
Post-marketing surveillance is designed to assess the safety and efficacy of REN in larger and more diverse populations than in clinical trials 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 in pre-adolescence migraine patients who used the Nerivio device. The following outcomes will be assessed:
- - Safety - Adverse events that were reported during the study's period
- - Efficacy - Pain relief, freedom from pain, improvement in functional disability, and improvement in migraine-associated symptoms following the treatment
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 6 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject age is between 6 to 12 at the date of the REN treatment
- •Subject used the Nerivio device at least once
排除标准
- 未提供
结局指标
主要结局
Rate of Device Related Adverse Events
时间窗: Up to 6 months
Incidence of device-related adverse events reported by subjects throughout the study period
次要结局
- Consistent Headache Relief at 2 Hours Post-treatment(up to 6 months)
- Consistent Freedom From Headache at 2 Hours Post-treatment(up to 6 months)
- Consistent Migraine Associated Symptoms Disappearance at 2 Hours Post-treatment(up to 6 months)
- Consistent Functional Disability Relief at 2 Hours Post-treatment(up to 6 months)
- Consistent Functional Disability Disappearance at 2 Hours Post-treatment(up to 6 months)