NCT07719608招募中不适用
Randomized, Double-Blind, Controlled Pivotal Trial of the MySalvia System for the Treatment of Resistant Migraine
Salvia BioElectronics3 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2026年12月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 150
- 试验地点
- 3
- 主要终点
- Primary Endpoint - Efficacy
研究概览
简要总结
The purpose of this pivotal clinical study is to evaluate the safety and effectiveness of the MySalvia System, a minimally invasive implantable neuromodulation therapy, for the preventive treatment of adults with resistant migraine.
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
- 22 Years 至 84 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Meets resistant migraine criteria:
- •Documented diagnosis of 1.1 migraine without aura and/or 1.2 migraine with aura and/or 1.3 chronic migraine according to ICHD-3
- •Headache requiring two of the following:
- •Leads to considerable impairment in personal, educational and/or occupational areas of functioning (MIDAS rating of severe or very severe)
- •Concomitant continuous or near continuous headache between migraine attacks
- •Eight or more monthly migraine days
- •Lack of 50% reduction in monthly migraine days and/or intolerable side effects and/or absolute contraindication to three or more (but not all) classes of at least one evidence-based medication. The classes must include Onabotulinumtoxin A and CGRP mabs/antagonists.
- •Not better accounted for by another ICHD-3 diagnosis
- •History of migraine onset before 50 years of age
- •Stable dose of all preventive migraine medication(s) and alternative therapies for at least three months before the start of the eligibility phase
排除标准
- •Presence of another chronic primary or secondary headache disorder, unless the participant can reliably differentiate these headaches attacks from migraine attacks, based on the pain characteristics and associated symptoms
- •Concurrent use of any invasive or non-invasive neuromodulation.
- •Previous inadequate response to an implantable neuromodulation device for headache or pain management.
- •Have an existing active implantable medical device nearby the implant location (e.g. DBS, cochlear implant).
- •Use of onabotulinum toxin A injections for the treatment of migraine in the past 3 months.
- •Presence of an active implantable medical device (e.g. pacemaker, implantable cardiac defibrillator, neurostimulator, cochlear implant).
- •Presence of metal or magnet implants in the skull or cranial region (e.g. skull plates, seeds)
- •Pregnant, nursing or not using contraception.
研究组 & 干预措施
Active Control Group
Active Comparator
干预措施: Neurostimulator (Device)
Active Group
Active Comparator
干预措施: Neurostimulator (Device)
结局指标
主要结局
Primary Endpoint - Efficacy
时间窗: 24 weeks
Proportion of participants achieving a ≥30% reduction in Monthly Migraine Days (MMD) at 24 weeks post device activation compared to baseline.
Primary Outcome Measure - Safety
时间窗: 24 Weeks
Incidence of serious procedure-, device- and/or stimulation-related adverse events among all participants at 24 weeks post-device activation.
次要结局
未报告次要终点
研究者
研究点 (3)
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