EFFICACY EVALUATION OF GREAT OCCIPITAL NERVE ELECTRICAL STIMULATION ON REBOUND HEADACHE AFTER WITHDRAWAL IN MEDICATION OVERUSE HEADACHE OCCURING IN MIGRAINE PATIENTS (SENGO-CAM Study)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 4
- 主要终点
- Primary endpoint will be the comparison of the rate of headache-free patients, fourteen days after medication withdrawal, in both groups (GONS versus sham)
研究概览
简要总结
SENGO-CAM study is a sham-controlled simple blind trial which aim is to study the efficacy of great occipital nerve stimulation (GONS) associated with medication withdrawal in the treatment of medication overuse headache occurring in migraine patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Single (Participant)
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 old
- •migraine patient with medication overuse headache by non specific analgesics according to the ICHD-II diagnostic criteria
- •failure of outpatient withdrawal
- •Signature of informed consent.
- •Affiliation to French national health and pensions organization
排除标准
- •pregnancy (positive pregnancy test at pre-study) and breast-feeding
- •patients with medication overuse headache by specific antimigraine treatment (triptans or/and ergot derivatives) according to the ICHD-II diagnostic criteria
- •previous surgical treatment targeting great occipital nerves
研究组 & 干预措施
Arm Active SENGO
The patients will be hospitalised and managed by medication withdrawal and active GONS, surgically temporarily implanted.
干预措施: great occipital nerve stimulation (Device)
Arm sham SENGO
The patients will be hospitalised and managed by medication withdrawal and sham GONS, surgically temporarily implanted.
干预措施: great occipital nerve stimulation (Device)
结局指标
主要结局
Primary endpoint will be the comparison of the rate of headache-free patients, fourteen days after medication withdrawal, in both groups (GONS versus sham)
时间窗: 14 days
次要结局
- number of headache days during the 14 days withdrawal period(14 days)
- maximal intensity and duration of rebound headache(14 days)
- rescue medication used(14 days)
- withdrawal facility perceived by the patient(14 days)