A Non-Invasive Neuromodulation Device for Treatment of Migraine Headache
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 12
- 主要终点
- Change in Number of Monthly Migraine Headache Days
研究概览
简要总结
This is a randomized, blinded study designed to assess the efficacy of a portable, non-invasive neuromodulation system for the treatment of episodic migraine headaches.
详细描述
This is a multi-center, triple-blinded, placebo-controlled, randomized pivotal trial evaluating the adjunctive prophylactic treatment of episodic migraine headache using a caloric vestibular stimulation (CVS) device developed by Scion NeuroStim, LLC (SNS). This study has been reviewed by the FDA and is categorized as posing NSR (nonsignificant 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
- •The patient must have been diagnosed with episodic Migraine Headache at least 6 months prior to entering into the Study, consistent with the International Headache Classification of Headache Disorders-II (ICHD-II) guidelines.
- •The patient must have a history of at least three consecutive months of stable Migraine Headaches prior to entering the Study. The patients will not have had changes in medication usage for the three Months leading up to the Study, nor will they introduce new medications during the Study period. Patients will satisfy these criteria: On a Monthly basis, at least four, and not more than a total of fourteen (4-14), Headache Days (Pain Score between one and ten) of which between four and nine (4-14) are Migraine Headache Days
- •The patient must not have failed on more than two classes of properly administered prophylactic pharmaceutical therapies for migraine headache. The patient may be on a single migraine prophylactic as long as the dosage has not been altered within 3 months of starting the study and the dosage must not be altered for the duration of the study.
- •The Investigator must have confidence in the patient's ability to reliably use the Experimental Device and promptly complete the Daily Headache Diary forms. The Daily Headache Diary will be completed from the beginning of the Pre-Treatment Baseline Period through the end of the Pivotal Study.
排除标准
- •Individuals who:
- •are pregnant
- •have a history of cardiovascular disease
- •work night shifts
- •have been diagnosed with vestibular migraine
- •have been diagnosed with migraine with aura
- •have menstrual migraine exclusively
- •have been diagnosed with post-traumatic migraine
- •have a history of unstable mood disorder or unstable anxiety disorder
- •use a hearing aid
- •have a cochlear implant
- •have chronic tinnitus
- •have temporomandibular joint (TMJ) disease
- •have been diagnosed with traumatic brain injury (TBI)
- •have been diagnosed with neurological disease other than Headaches
- •have a diagnosed vestibular dysfunction
- •abuse alcohol or other drugs
- •are experiencing medication overuse Headaches (individuals with respect to whom the Investigator is concerned that analgesic abuse is involved based on the ICHD-II guidelines).
- •are younger than 18 years or older than 65 years
- •have had eye surgery within the previous three months or ear surgery within the previous six months
- •have active ear infections or a perforated tympanic membrane
- •have participated in another clinical trial within the last 30 days or are currently enrolled in another clinical trial
- •are using Botox treatments for migraines
- •Though not excluded, patients taking anti-histamines or anti-nausea drugs will be encouraged not to take such medications within four hours prior to using the Device. The Investigator should review other medications taken by the patient with properties that mimic anti-nausea or anti-dizziness drugs as these may reduce responsiveness to stimulation. Such medications should also be avoided within four hours prior to a treatment.
研究组 & 干预措施
active device
A standardized active neuromodulation waveform will be used for all active Device patients at all Study sites. The Device will be used twice daily.
干预措施: neuromodulation for episodic migraine headache (Device)
placebo device
A standardized placebo neuromodulation waveform will be used for all placebo Device patients at all Study sites. The Device will be used twice daily.
干预措施: neuromodulation for episodic migraine headache (Device)
结局指标
主要结局
Change in Number of Monthly Migraine Headache Days
时间窗: after 84 days of Device use
Change in the average total number of Monthly Migraine Headache Days (number of days in the month that a participant experienced a migraine) after 3 months of treatment comparable to the pre-device use Baseline Period of 1 month, as reported in a headache diary. Negative number indicated improvement (a reduction in the average number of migraine headache days experienced per month).
次要结局
- Number of Monthly Migraine Headache Days (Reduction by by 50% or More)(after 84 days of Device use)
- Total Monthly Headache Pain Score(after 84 days of Device use)
- (Safety Measure) Mood and Cognition - Change in Beck Depression Index Score(after 84 days of Device use)
- (Safety Measure) Dizziness: Verify the Absence of Change in Material Dizziness (Berg Balance)(after 84 days of Device use)
- (Safety Measure) Mood and Cognition - Change in Digit Symbol Coding Cognitive Speed(after 84 days of Device use)
- (Safety Measure) Mood and Cognition Measure - Change in Short Term Memory Test Scores(after 84 days of Device use)
- Average of Monthly Treated Headaches (Acute Anti-migraine Prescription Drug Intake)(after 84 days of device use)