NCT03631550已完成不适用
The RIME Study - Combined Occipital and Supraorbital Transcutaneous Nerve Stimulation for Treatment of Migraine
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 187
- 试验地点
- 17
- 主要终点
- Proportion of Subjects Reporting Reduction of Migraine Headache Pain at 2 Hours From Treatment Initiation
研究概览
简要总结
this study will evaluate the clinical performance and safety of a self administered abortive treatment for migraine headache using combined occipital and supraorbital transcutaneous nerve stimulator (Neurolief device, Relivion®)
详细描述
The Relivion® is a non-invasive transcutaneous neuro-stimulator is indicated for the acute treatment of migraine with or without aura in subjects 18 years of age or older. The Relivion® is intended to be a prescription device, self-used at home.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects 18 years of age and older.
- •Subject meets the ICHD (International Classification of Headache Disorders)-3 (2018) diagnostic criteria for Migraine with or without aura.
- •Subject reports 1-6 Migraine attacks per month; other headaches no more than 6 days per month.
- •Subject is willing to and capable of complying with the specified study requirements, provided written Informed Consent, can complete the electronic diaries, and can be contacted by telephone.
排除标准
- •Subject having received Botox treatment in the head region in the prior 3 months.
- •Subject having received supraorbital or occipital nerve blocks in the prior month.
- •Past 6 months of chronic migraine, New Daily Persistent Headache, and chronic tension-type headache per ICHD-3 (2018) diagnostic criteria.
- •Current medication overuse headache.
- •Use of opioid medications in the prior 1 month.
- •Use of barbiturates in the prior 1 month.
- •Subject has >10 headache days per month
- •Implanted metal/shrapnel or electrical devices in the head (not including dental implants), a cardiac pacemaker or an implanted or wearable defibrillator.
- •Received parenteral infusions for migraine within the previous 2 weeks.
- •Subject has known uncontrolled epilepsy.
- •History of neurosurgical interventions
- •Subject with implanted neurostimulators, surgical clips (above the shoulder line) or any medical pumps.
- •Current drug abuse or alcoholism.
- •Subject is participating in any other clinical study.
- •Skin lesion or inflammation at the region of the stimulating electrodes.
- •Personality or somatoform disorder.
- •Pregnancy or Lactation.
- •Women with child bearing potential without medically acceptable method of contraception (NOTE: Females of child bearing potential must have a negative pregnancy test).
- •Documented history of cerebrovascular event.
- •Subject with recent brain or facial trauma (occurred less than 3 months prior to this study).
- •Subject participated in a previous study with the Relivion device.
- •The subject does not have the basic cognitive and motor skills needed to operate a smartphone.
- •Subject with head circumference smaller than 51 centimeters or head circumference larger than 60 centimeters
- •Subject with other significant pain problem that in the opinion of the investigator may confound the study assessments.
结局指标
主要结局
Proportion of Subjects Reporting Reduction of Migraine Headache Pain at 2 Hours From Treatment Initiation
时间窗: 2 hours from treatment initiation
the number and percent of subjects reporting reduction of migraine headache pain 2 hours post treatment initiation from severe or moderate to mild or no pain, or from mild to no pain, in their first eligible treated migraine attack (if rescue therapy was not used)
次要结局
- Proportion of Subjects Reporting Reduction of Migraine Headache Pain 1-hour Post Treatment Initiation(1 hour from treatment initiation)
- Proportion of Subjects Reporting Improvement in Their Most Bothersome Symptom (MBS) Other Than a Headache, 2 Hours Post-treatment Initiation(2 hours from treatment initiation)
- Proportion of Subjects Who Are Pain Free at 2 Hours Post Treatment Initiation(2 hours from treatment initiation)
研究者
研究点 (17)
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