NCT03185559终止不适用
A Prospective, Randomized, Double-blind, Parallel-group, Sham Controlled Single-center Pivotal Clinical Investigation to Evaluate the Clinical Safety and Performance of Self-administered Home-use Combined Occipital and Supraorbital Transcutaneous Nerve Stimulation Device (Relievion™) in Treating Migraine.
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Pain Visual Analogue Scale (VAS) Change from basline to 1 hour
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, Relievion™).
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •History of episodic or chronic migraine with or without aura meeting the diagnostic criteria listed in ICHD-III (International Classification of Headache Disorders) beta (2013) section 1, migraine, with the exception of ''complicated migraine'' (i.e., hemiplegic migraine, basilar-type migraine, ophthalmoplegic migraine, migrainous infarction).
- •Capable of cooperating with the study protocol and to sign an informed consent.
排除标准
- •Patients having received Botox treatment in the head region in the prior 4 months.
- •Patients having received supraorbital or occipital nerve blocks in the prior 4 months.
- •History of Medication Overuse Headache.
- •Patients using opioid medication.
- •Allodynia: intolerance to supraorbital and/or occipital neurostimulation (allodynia) that makes the treatment not applicable (the patients will be excluded if they are unable to tolerate the first 3 minutes of neurostimulation).
- •Implanted metal or electrical devices in the head (not including dental implants).
- •Patient having had a previous experience with the Relievion™ device.
- •Patients who have concomitant epilepsy.
- •History of neurosurgical interventions.
- •Patients with implanted neurostimulators, surgical clips (above the shoulder line) or any medical pumps.
- •History of drug abuse or alcoholism.
- •Participation in current clinical study or participated in a clinical study within 3 months prior to this study.
- •Skin lesion or inflammation at the region of the stimulating electrodes.
- •Personality or somatoform disorder.
- •Pregnancy or Lactation.
- •Women of reproductive age not using efficient contraceptive method.
- •History of cerebrovascular event.
- •Subjects with recent brain or facial trauma (occurred less than 3 months prior to this study).
研究组 & 干预措施
Relievion device- Treatment stimulation
Active Comparator
Relievion Device- Treatment combined occipital and supraorbital transcutaneous nerve stimulation
干预措施: Relievion Device- Treatment Stimulation (Device)
Relievion device- Sham Stimulation
Sham Comparator
Relievion Device- Sham combined occipital and supraorbital transcutaneous nerve stimulation
干预措施: Relievion Device- Sham stimulation (Device)
结局指标
主要结局
Pain Visual Analogue Scale (VAS) Change from basline to 1 hour
时间窗: 1 Hour
Mean change of pain score (measured on a visual analog scale) at 1 hour compared to baseline (if rescue therapy was not used)
次要结局
- Pain VAS change from baseline to 30 minutes(30 minutes)
- Pain VAS change from baseline to 2 hours(2 Hours)
- Pain VAS change from baseline to 24 hours(24 Hours)
- Pain VAS change from baseline to 48 hours(48 Hours)
- Rescue medication at 2 hours(2 hours)
- Rescue medication within 24 hours(24 hours)
- Rescue medication within 48 hours(48 hours)
研究者
研究点 (1)
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