Real-world Analysis of Remote Electrical Neuromodulation (REN) for the Acute Treatment of Migraine
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 12,151
- 试验地点
- 2
- 主要终点
- Safety (number of users reporting device/treatment-related adverse events)
研究概览
简要总结
Data analysis concerning four sets of metrics: A. Per-treatment patterns of REN use as a standalone treatment vs. in combination with medications. B. Per-user Intra-individual consistency of efficacy across multiple treatments (consistency defined as a response to treatment in at least 50% of treatments). C. Distribution of treatment intensity among users (the electroceutical equivalent to treatment dose). D. Prevalence and severity of adverse events.
详细描述
The REN device The REN device is a wearable device applied to the upper arm and 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 can be adjusted by the patient.
Data collection 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 were 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 indication of which medications, if any, were taken within that 2-hour time window.
Dataset Real-world data of REN treatments collected from patients across the United States who used the REN device.
'Treatment' defined as a REN treatment of at least 20 minutes (the nominal duration is 45 minutes).
'Evaluable treatment' defined as a treatment in which pain levels were reported at baseline and post 2 hours.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •REN users in the U.S.
排除标准
- •Cohort 1 REN treatments that were shorter than 20 minutes or did not have a report of pain level.
- •Cohort 2 Treatments in which medications were taken within 2 hours from REN treatment. Users that had less than 2 REN treatments.
- •Cohort 3 REN treatments that were shorter than 20 minutes
- •Cohort 4 All REN sessions, regardless of duration or medication intake.
结局指标
主要结局
Safety (number of users reporting device/treatment-related adverse events)
时间窗: 20 months
The percentage of users reporting adverse events, out of the overall number of users, and the severity of the treatment/device-related adverse events.
REN-medication combinations- prevalence
时间窗: 2 hours from treatment onset
Medication intake outcomes calculated based on the 2h post-treatment report and comprised of the percentage of treatments in which no rescue medications were used, treatments in which OTC medications were taken, treatments in which triptans were taken, treatments in which other prescription medications were taken, and treatments in which medication intake status was not reported. OTC included acetaminophen, NSAIDs, and combinations of the two, with or without caffeine.
percentage of users that achieve consistency of efficacy
时间窗: 2 hours from treatment onset
Consistency defined as a response of a patient to the treatment in at least 50% of their treated attacks, and calculated for the four efficacy outcomes: (i) consistency of pain relief (ii) consistency of pain-freedom (iii) consistency of improvement in function; and (iv) consistency of return to normal function.
REN-medication combinations- efficacy of the combinations
时间窗: 2 hours from treatment onset
The efficacy of treatments in which medications were taken will be calculated based on the 2 hours post-treatment pain report. The overall efficacy rate will be calculated as the percentage of treatments in which response to the treatment was achieved, out of all the treatments.
Treatment intensity distribution
时间窗: 20 minutes from treatment onset
The mean intensity of the stimulation collected for all treatments that were 20 minutes or longer, which were performed within the study's time window.
次要结局
未报告次要终点