NCT05868044进行中（未招募）不适用
REsponse to Combined SuPra-orbital and Occipital Nerve Stimulation in Chronic Cluster headachE With the PRIMUS System, a First in Human Study
Salvia BioElectronics2 个研究点 分布在 1 个国家目标入组 5 人开始时间: 2023年5月2日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 5
- 试验地点
- 2
- 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 cluster headache. This is a single-centre, open label, prospective, first in human study to collect initial clinical data on the PRIMUS system for the treatment of chronic cluster headache.
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 —（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
- •Documented chronic cluster headache for at least 1 year as per ICHD-3 criteria
- •Attack frequency of ≥ 4 attacks per week for ≥ 4 weeks before enrolment
- •Documented failure of verapamil (failure meaning ineffective, provoked unacceptable side-effects or contra-indicated)
- •Stable on preventive treatment for at least two weeks prior to enrolment.
- •Agree to refrain from starting new prophylactic cluster headache medication or other preventive 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 enrolment) or willing to undergo an MRI to exclude structural lesions potentially causing headache
- •Able and willing to complete a headache Diary
排除标准
- •Any other chronic primary or secondary headache disorder, unless they can clearly differentiate them from cluster headache attacks based on the quality and associated symptoms
- •Concomitant neuromodulation, except tVNS
- •Previous failure to any 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 or implantable cardioverter defibrillator (ICD)
- •Suboccipital infiltrations with steroids and/or local anaesthetics or use of oral steroids in the past 3 months
- •Use of botulinum toxin injections in the past 12 weeks
- •Calcitonin gene-related peptide inhibitors started less than 12 weeks prior to enrolment
- •Women of childbearing age who are pregnant, nursing or not using contraception
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 the end of the study.
次要结局
未报告次要终点
研究者
研究点 (2)
Loading locations...
相似试验
进行中（未招募）
不适用
First Evaluation of a Craniofacial Nerve Stimulation System in Chronic MigraineChronic MigraineNCT05858801Salvia BioElectronics7
已完成
不适用
Short-term Effectiveness of Transcutaneous Nerve Stimulation in Reducing Migraine Related PainHeadache, MigraineNCT02438553Neurolief Ltd.40
已完成
2 期
Oxulumis® Suprachoroidal Microcatherization of Triesence® in Diabetic Macular EdemaDiabetic Macular EdemaNCT05512962Oxular Limited25
已完成
2 期
A Study to Evaluate the Safety and Clinical Response of Subretinal Administration of CNTO 2476 in Participants With Geographic AtrophyGeographic AtrophyVisual AcuityMacular DegenerationNCT02659098Janssen Research & Development, LLC21
已完成
不适用
The Effect of Combined Bilateral Infraorbital and Infratrochlear Nerve Block in Nasal SurgeriesAnesthesiaNCT06174675Ain Shams University40