NCT01532830已完成不适用
Non-Invasive Neurostimulation of the Vagus Nerve With the GammaCore Device For the Relief of Symptoms Associated With Migraine
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 6
- 主要终点
- Safety - Number of Participants With Adverse Effects
研究概览
简要总结
The purpose of this pilot study is to assess feasibility and clarify the design of future study(ies) to support marketing approval of the GammaCore™ device for the treatment and/or prevention of migraine symptoms.
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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Is between the ages of 18 and 55 years.
- •Has been previously diagnosed as suffering from migraine, in accordance with the ICHD-2 Classification criteria (2nd), with or without aura.
- •Experiences at least 2 migraines per month, but less than 15 headache days per month (over the last 3 months).
- •Has age of onset of migraine less than 50 years old.
- •Is able to give written Informed Consent
排除标准
- •Has a history of aneurysm, intracranial hemorrhage, brain tumors or significant head trauma.
- •Has a lesion (including lymphadenopathy) at the GammaCore™ treatment site.
- •Has known or suspected severe atherosclerotic cardiovascular disease, severe carotid artery disease (e.g. bruits or history of TIA or CVA), congestive heart failure (CHF), coronary artery disease or recent myocardial infarction.
- •Has a history or baseline ECG that identifies the presence of a clinically significant unstable cardiac arrhythmia, second degree heart block type II, history of ventricular tachycardia or ventricular fibrillation, or known cardiac syndromes that may be associated with increased risk of sudden death in otherwise healthy people.
- •Has had a previous bilateral or right cervical vagotomy.
- •Has a clinically significant irregular heart rate or rhythm.
- •Has uncontrolled high blood pressure.
- •Is currently implanted with an electrical and/or neurostimulator device, including but not limited to cardiac pacemaker, vagal neurostimulator, deep brain stimulator, spinal stimulator, bone growth stimulator, or cochlear implant.
- •Has a history of carotid endarterectomy or vascular neck surgery on the right side.
- •Has been implanted with metal cervical spine hardware or has a metallic implant near the GammaCore™ stimulation site.
- •Has a recent or repeated history of syncope.
- •Has a recent or repeated history of seizure.
- •Has a history or suspicion of narcotic abuse.
- •Takes medication for acute headaches more than 10 days per month.
- •Is pregnant, nursing, thinking of becoming pregnant in the next 3 months, or of childbearing years and is unwilling to use an accepted form of birth control.
- •Is participating in any other therapeutic clinical investigation or has participated in a clinical trial in the preceding 30 days.
- •Belongs to a vulnerable population or has any condition such that his or her ability to provide informed consent, comply with follow-up requirements, or provide self-assessments is compromised (e.g., homeless, developmentally disabled, prisoner).
- •Is a relative of or an employee of the investigator or the clinical study site.
研究组 & 干预措施
Active
Experimental
n-VNS active therapy
干预措施: n-VNS (Device)
结局指标
主要结局
Safety - Number of Participants With Adverse Effects
时间窗: End of Study - 7 weeks
The primary outcome measure for this study was the assessment of adverse events as unanticipated or anticipated.
次要结局
- Change in Photophobia (Visual) From Baseline to 120 Minutes(Base line and 120 minutes)
- Change in Phonophobia (Auditory) From Baseline to 120 Minutes(Baseline and 120 minutes)
- Mean Change in Headache Pain From Baseline to 120 Minutes(120 minutes)
- Mean Change in Nausea From Baseline to 120 Minutes(Baseline 120 minutes)
- Mean Change in Functional Disability(Baseline and 120 minutes)
研究者
研究点 (6)
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