An Open Label, Single Arm, Multicenter Study Assessing the Efficacy and Safety of Nerivio, a Remote Electrical Neuromodulation Device, for Acute Treatment of Migraine in People With Chronic Migraine
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 126
- 试验地点
- 20
- 主要终点
- Pain Relief at 2 Hours Post-treatment
研究概览
简要总结
A prospective, single arm, open-label, multicenter trial to assess the efficacy and safety of the Nerivio device in chronic migraine patients. This study will be conducted in three phases:
Phase I - Run-in:
Eligible participants will be trained to use a smartphone migraine diary application. During the 4 weeks of this phase, participants will be instructed to report all their migraines and headaches at onset, 2 hours and 24 hours post report .
Phase II - Treatment:
A 4-week treatment phase in which participants will be asked to treat their migraine headaches with the Nerivio device and report it using the smartphone application at baseline, 2 hours and 24 hours post-treatment.
Phase III - Follow-up:
An 8-week follow-up phase in which participants will incorporate the Nerivio device into their usual care according to their preference (Nerivio only, medication only, both or none). Participants will be asked to report all their migraines or headaches at onset, 2 hours post report and 24 hours post report.
详细描述
This open label study includes up to four visits. The enrollment and application training may occur in two separate visits instead of one.
First visit - The first visit will include screening, enrollment and training on the application.
Enrollment: The screening process will include an eligibility assessment and a urine pregnancy test. Following successful screening, the site staff will provide the participants with study related information, perform an enrollment interview and receive an informed consent from the participants. During this visit, participants will complete baseline questionnaires that included information on the frequency and severity of their migraine attacks, typical associated symptoms, use of preventive and acute treatments, and the effect that their migraine attacks have on their daily routine and quality of life.
Application training: Eligible participants who enroll to the study will be trained to use the diary mode of the application that is installed on their own smartphones. The participants will be instructed to report the onset of all their migraines and headaches and complete a migraine diary questions regarding their pain intensity levels, the presence/absence of aura and associated migraine symptoms (nausea, photophobia, phonophobia, and allodynia) as well as rate their stress level and functional disability at baseline, 2- and 24-hours post-treatment. At the beginning of each treatment, participants will also be asked to report the time elapsed from attack onset. The site personnel will be required to document the training session in the Case Report Form (CRF).
Run-in phase: After the enrollment visit, participants will undergo a 4-week migraine diary phase aimed to collect baseline migraine characteristics and further assess eligibility. The participants will use the app to record pain intensity levels, the presence/absence of aura and associated migraine symptoms (nausea, photophobia, phonophobia, and allodynia) as well as the effect that their migraine attacks have on their daily routine and quality of life, at baseline, 2- and 24-hours post-treatment. These reports will be transferred by the application to the electronic data capture (EDC) system, where they will be collected and registered.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants aged 18-75 years old.
- •Participants meeting the International Classification of Headache Disorders-3 (ICHD-3) diagnostic criteria for chronic migraine
- •Participants experiencing between 15 to 23 headache days per month, with at least 8 headache days (per month) with migraine phenotype presentation
- •Participants have personal access to a smartphone
- •Participants must be able and willing to comply with the protocol
- •Participants must be able and willing to provide written informed consent
排除标准
- •Participants with an active implanted electrical and/or neurostimulator device (e.g. cardiac pacemaker, cochlear implant).
- •Participants with congestive heart failure (CHF), severe cardiac or cerebrovascular disease.
- •Participants with uncontrolled epilepsy.
- •Lack of efficacy, after an adequate therapeutic trial, of at least two migraine specific acute medications.
- •Change in migraine preventive medications (type or dose) in the last two months prior to recruitment and/or during the study
- •Pregnant, trying to get pregnant or breastfeeding female participants
- •Subjects participating in any other interventional clinical study.
- •Participants without basic cognitive and/or motor skills needed to operate a smartphone
- •Participants with other significant pain, medical or psychological problems that in the opinion of the investigator may confound the study assessments
- •Participants who have previous experience with the device
结局指标
主要结局
Pain Relief at 2 Hours Post-treatment
时间窗: 2 hours post-treatment
The proportion of subjects reporting, for the test treatment, pain relief at 2 hours post-treatment without the use of rescue medication. Pain relief is defined as an improvement from severe or moderate pain to mild or no pain, or from mild pain to no pain. Pain level will be reported using a 4-point Likert scale (0 - No pain, 1 - Mild pain, 2 - Moderate pain, 3- Severe pain)
次要结局
- Disappearance of Nausea at 2 Hours Post-treatment(2 hours post treatment)
- Pain-free at 2 Hours Post-treatment(2 hours post-treatment)
- Disappearance of Photophobia at 2 Hours Post-treatment(2 hours post treatment)
- Disappearance of Phonophobia at 2 Hours Post-treatment(2 hours post treatment)