NCT02991430终止不适用
A Non-Invasive Neuromodulation Device for Prevention of Episodic Migraine Headache
Scion NeuroStim20 个研究点 分布在 2 个国家目标入组 45 人开始时间: 2017年6月30日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 45
- 试验地点
- 20
- 主要终点
- Change in Migraine Headache Days (MHD)
研究概览
简要总结
This study will assess the efficacy of a neuromodulation device for the treatment of episodic migraine headache.
详细描述
This study is a multi-center, triple-blinded, placebo-controlled, randomized clinical trial for adjunctive prophylactic treatment of episodic migraine headache (with or without aura) using neuromodulation device developed by Scion NeuroStim, LLC (SNS). The investigational use of the device for episodic migraine headache has been reviewed by the FDA and is classified as NSR (non-significant risk).
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
- Triple (Participant, 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
- •diagnosed with episodic migraine at least 6 months before study
- •at least 3 consecutive months of stable migraine headaches before study
- •at least 4-14 headache days per month, of which 4-14 may be migraines
- •must not have failed on more than 2 classes of migraine preventatives
排除标准
- •previous use of the experimental device
- •using more than 1 concurrent migraine preventive
- •history of cardiovascular disease
- •work night shifts
- •diagnosed with vestibular migraine
- •menstrual migraines exclusively
- •diagnosed with post-traumatic migraine
- •have a history of unstable mood or anxiety disorder
- •use a hearing aid
- •have a cochlear implant
- •have chronic tinnitus
- •have temporomandibular joint disease
- •diagnosed with traumatic brain injury
- •diagnosed with neurological disease other than headaches
- •diagnosed vestibular and/or balance dysfunction
- •history of abusing alcohol or other drugs
- •are experiencing medication overuse headaches
- •have had eye surgery in the previous 3 months
- •have had ear surgery in the previous 6 months
- •have active ear infections or a perforated tympanic membrane
- •have participated in another clinical trial in the last 30 days
- •are currently participating in another clinical trial
- •using Botulinum toxin-based treatments for migraines or cosmetic reasons
- •taking anti-emetics more than 2 times per week (consistently)
结局指标
主要结局
Change in Migraine Headache Days (MHD)
时间窗: 1 month of baseline recordation followed by 84 days of device use
comparison of MHD recorded in baseline month versus 3rd month of treatment
次要结局
- Change in Anxiety(1 month of baseline recordation followed by 84 days of device use)
- Sustained Reduction in Migraine Headache Days(1 month of baseline recordation followed by 252 days of device use)
- Change in Depression(1 month of baseline recordation followed by 84 days of device use)
- Normalized Reduction in Migraine Headache Days(1 month of baseline recordation followed by 84 days of device use)
- Change in Sleep Quality(1 month of baseline recordation followed by 84 days of device use)
- Additional Treatment Time(1 month of baseline recordation followed by 168 days of device use)
- Change in Medication Usage(1 month of baseline recordation followed by 84 days of device use)
- Change in Headache Pain(1 month of baseline recordation followed by 84 days of device use)
- Change in Quality of Life(1 month of baseline recordation followed by 84 days of device use)
研究者
研究点 (20)
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