NCT05700318招募中不适用
A Pilot Study Assessing Preliminary Safety and Efficacy of The ShiraTronics Migraine Therapy System in Relieving, Interrupting, and Preventing Chronic Migraine
ShiraTronics4 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2023年5月5日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 4
- 主要终点
- Monthly Headache Days
研究概览
简要总结
The purpose of this pilot study is to assess the preliminary safety and efficacy of the ShiraTronics Migraine Therapy System in prophylactic treatment of patients with refractory chronic migraine.
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
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants who are 22 years of age or older.
- •History of migraine ≥ 12 months.
- •Participants experiencing between 15 to 26 headache days per month, with at least 8 headache days (per month) with migraine phenotype presentation.
- •Inadequate response to, unwilling, or contraindicated to Onabotulinumtoxin A and CGRP monoclonal antibodies therapy.
- •Stable use of migraine medication.
排除标准
- •Post-traumatic headache.
- •Medication overuse headache.
- •New daily persistent headache.
- •Report experiencing unremitting, continuous headaches with no relief.
- •Previously implanted neurostimulator to treat headache.
- •History of cervical radiofrequency ablation or had any other intervention/device for migraine.
结局指标
主要结局
Monthly Headache Days
时间窗: 12-weeks
Change in number of mean monthly headache days
次要结局
- 50% reduction in mean Headache days(12-weeks)
- Migraine Disability Assessment Test(12-weeks)
- Monthly Migraine Days(12-weeks)
- Patient-identified Most Bothersome Symptom(12-weeks)
研究者
研究点 (4)
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