NCT06450444招募中不适用
Randomized, Double-blind, Controlled Trial to Investigate Combined Occipital and Supra-orbital Neuromodulation in Resistant Migraine. The RECLAIM Study.
Salvia BioElectronics19 个研究点 分布在 3 个国家目标入组 110 人开始时间: 2024年6月24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
- 110
- 试验地点
- 19
- 主要终点
- Safety Evaluation
研究概览
简要总结
The purpose of this study is to evaluate the safety and performance, including clinical benefit, of the PRIMUS System for the treatment of 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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 84 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of migraine as defined by the ICHD-3 Classification (with or without aura) with a history of chronic or high-frequency episodic migraine for at least 1 year prior to screening
- •Failure of 3 or more preventive pharmacological therapies
- •Stable on preventive migraine treatments
- •Psychologically stable
排除标准
- •Concomitant invasive or non-invasive neuromodulation
- •Previous exposure to an implantable neuromodulation device for headache
- •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.
- •Use of local corticosteroid injections in the occipital or supra-orbital region in the past 3 months prior to enrollment.
- •Not pregnant, nursing or not using contraception
研究组 & 干预措施
Cohort 2 - Therapy V
Experimental
Active therapy modality
干预措施: PRIMUS (Device)
Cohort 1 - Control Group
Other
Sham therapy
干预措施: PRIMUS (Device)
Cohort 1 - Treatment Group
Experimental
Active therapy modality
干预措施: PRIMUS (Device)
Cohort 2 - Therapy D
Experimental
Active therapy modality
干预措施: PRIMUS (Device)
结局指标
主要结局
Safety Evaluation
时间窗: 12 weeks
The incidence of serious procedure, device and/or stimulation-related adverse events.
Effectiveness Evaluation
时间窗: 12 weeks
Proportion of subjects with ≥ 30% reduction in the number of Monthly Migraine Days (MMD), in randomized arms.
次要结局
未报告次要终点
研究者
研究点 (19)
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