Study of the Cerebral Metabolism in Patients With Refractory Chronic Cluster Headache Treated by Occipital Nerve Stimulation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 4
- 主要终点
- Comparison of cerebral metabolism
研究概览
简要总结
The occipital nerve stimulation (ONS) is used to treat patients with refractory primary chronic headache but its mechanism of action (MoA) remains unknown. Different hypothesis have been suggested in particular a specific action on cerebral generators involved in different types of primary headaches or a non specific action on pain modulatory network.
The aim of this study, using the chronic cluster headache as a model, is to determine the changes in cerebral metabolism induced by ONS to precise its MoA in the treatment of primary chronic 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
- Health Services Research
- 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
- •age > 18 years
- •chronic cluster headache (according to the IHS)
- •refractory in who a treatment by ONS have been indicated
- •patient affiliated at social security,
- •informed consent signed
排除标准
- •contraindication to MRI
- •contraindication to 18F-FDG PET
- •women without contraception/pregnant/breast-feeding
- •patient non-compliant
- •patient on legal guardianship
研究组 & 干预措施
subjects with refractory chronic cluster headache
Adult subjects with refractory chronic cluster headache and ONS indication
干预措施: 18F-FDG PET (Radiation)
结局指标
主要结局
Comparison of cerebral metabolism
时间窗: Baseline (before ONS), 1 week after ONS , 3 month after ONS
Changes of cerebral metabolism associated with ONS efficacy
次要结局
未报告次要终点