NCT05858801进行中（未招募）不适用
First Evaluation of a Craniofacial Peripheral Nerve Stimulation System in Chronic Migraine, an Early Feasibility Study
Salvia BioElectronics1 个研究点 分布在 1 个国家目标入组 7 人开始时间: 2023年5月9日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- Safety Evaluation
研究概览
简要总结
The purpose of this study is to demonstrate the safe use of the PRIMUS system in subjects with chronic migraine. This is a single-center, open label, prospective, early feasibility study to collect initial clinical data on the PRIMUS system for the treatment of 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
- Device Feasibility
- 盲法
- None
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
- •Main Inclusion Criteria:
- •Able and willing to provide informed consent
- •Age ≥ 18 years and ≤ 84 years at time of consent
- •Documented Chronic Migraine, defined as at least eight migraine days/month, for at least 1 year.
- •Developed migraine before the age of 50
- •Documented failure of 3 or more other preventive therapies (failure meaning ineffective, provoked unacceptable side-effects or contra-indicated) from which at least 1 of the following 2: CGRP mAbs or Onabotulinumtoxin A
- •Have at least 1 headache free day per month
- •Stable on preventive migraine drugs and alternative treatment for at least three months prior to enrollment.
- •Agree to refrain from starting new preventive migraine drugs or other preventive alternative migraine treatments, from 4 weeks before entering the baseline period throughout the duration of the study.
- •MRI available (not older than 4 years prior to study enrollment) or willing to undergo an MRI to exclude structural lesions potentially causing headache
- •Able and willing to complete a daily headache eDiary
排除标准
- •Any other chronic primary or secondary headache disorder, unless they can clearly differentiate them from migraine attacks, based on the quality of pain and associated symptoms.
- •Concomitant neuromodulation
- •Previous failure to an implantable neuromodulation device for neurovascular headache
- •Have an existing Active Implantable Medical Device nearby the implant location (e.g. DBS, cochlear implant, …)
- •Metal implants in the skull (e.g. skull plates, seeds) nearby the implant.
- •Have a pacemaker of implantable cardioverter defibrillator (ICD)
- •Current Opioid Use, defined as one or more opioids on more than 4 days/month for 3 consecutive months.
- •Use of botulinum toxin injections in the past 3 months.
- •Women of childbearing age who are pregnant, nursing or not using contraception
研究组 & 干预措施
PRIMUS
Experimental
PRIMUS system
干预措施: PRIMUS (Device)
结局指标
主要结局
Safety Evaluation
时间窗: 12 months
The primary safety assessment is the incidence of serious procedure- and/or device-related adverse events in all subjects at 30 days and at the end of the study. All adverse clinical events will be collected, coded, and reported, for the duration of the study according to the definitions of ISO 14155:2020.
次要结局
未报告次要终点
研究者
研究点 (1)
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