NCT06124534暂停不适用
Bilateral Occipital Nerve Field Stimulation for the Prophylactic Treatment of Difficult-to-treat Chronic Cluster Headache
Man and Science, SA1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2023年10月19日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Safety Evaluation of the Device [Time Frame:12 weeks / 48 weeks]
研究概览
简要总结
The purpose of this study is to assess the initial safety, tolerability, and effectiveness of the novel BliStim occipital nerve field stimulation therapy for the prevention of chronic cluster headaches. This is a prospective, first in human study.
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
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ICHD-3 criteria for chronic cluster headache
- •Documented history of CCH since at least 2 years
- •Minimum mean attack frequency of 4 attacks per week
- •Age range: 18-70 years
- •Difficult-to-treat CCH with documented previous complete failure, insufficient efficacy, intolerance, or contra-indications to most preventive CH treatments among which are oral steroids or suboccipital infiltrations, verapamil, lithium carbonate and topiramate.
- •No preventive CH treatment or stable preventive CH medication for ≥ 2 weeks before enrolment. Subject agrees not to change existing treatment during the whole duration of the trial.
- •Subject written informed consent provided before enrolment
- •Subject willing and capable of subjective evaluation and to fill in an electronic CH diary, to understand questionnaires, and to read, understand and sign the written informed consent form.
- •Subject willing and able to comply with study-related requirements, procedures, and visits.
排除标准
- •Other significant neurological, psychiatric, or disabling diseases which in the opinion of the investigator may interfere with the study.
- •History of epilepsy, current treatment of epilepsy
- •Documented history of cerebrovascular accident (CVA)
- •Subjects suffering from a substance use disorder, as defined by Diagnostic and Statistical Manual of Mental Disorders (DSM) criteria. Recreational use of cannabis is allowed.
- •Subjects at high risk of suicide/suicidal ideation in the past one year assessed with the C-SSRS
- •Having another active implanted device such as a cardiac pacemaker, a spinal cord, peripheral nerve, sphenopalatine ganglion, or deep brain hypothalamic stimulator, and/or a drug delivery pump, etc.
- •Cranial botulinum toxin injections in the past 3 months before enrolment. Administration of the following treatments in the last month before enrolment: monoclonal antibodies blocking calcitonin gene-related peptide transmission, suboccipital infiltrations with steroids and/or local anaesthetics, oral steroids, radiofrequency procedure or infiltrations of the sphenopalatine ganglion, opioids WHO
- •Medication overuse headache (ICHD 3 8.2)
- •Inability to fill out an electronic diary.
- •Previous surgery or trauma involving the cervical spine or the occipital bone
- •Coagulopathy or required anticoagulant medications that cannot be safely discontinued in the perioperative period.
- •Concurrent participation in another clinical study
- •Planned pregnancy, pregnancy, or breastfeeding.
结局指标
主要结局
Safety Evaluation of the Device [Time Frame:12 weeks / 48 weeks]
时间窗: 12-weeks post implantation and through study completion at 48 weeks
The primary endpoint is safety and is assessed through the incidence of procedure related and/or device-related adverse events during the 12-weeks post implantation and the rate of all adverse events during the entire 48-week study period.
次要结局
未报告次要终点
研究者
研究点 (1)
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