跳至主要内容
临床试验/NCT01842763
NCT01842763进行中(未招募)不适用

French Database of Occipital Nerves Stimulation in the Treatment of Refractory Chronic Headache Disorders

Centre Hospitalier Universitaire de Nice16 个研究点 分布在 1 个国家目标入组 246 人开始时间: 2013年3月最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
246
试验地点
16
主要终点
observation of a disease or medical condition under normal conditions

研究概览

简要总结

The purpose of this non interventional research is to set up a French database, initially for 3 years, of patients suffering from refractory chronic headache disorders (chronic migraine, cluster headache, chronic paroxysmal hemicranias, SUNCT syndrome, hemicrania continua, cervicogenic headache disorders), and treated by occipital nerves stimulation.

Every team using this neuromodulation approach in France is likely to participate in the network.

Fifty patients a year are expected. They will be informed about data which are collected and why they are collected.

The data will come from medical files and questionnaires filling out by the patients. The data will be collected on a case report form adapted to each refractory chronic headache disorder. The case report form pages will be faxed to the coordinating team who will enter the data in the database and analyse the data in a descriptive manner.

These data are social and demographic data, medical data (headache features, headache functional and emotional impact, medications, and concomitant medical conditions), technical data (kind of electrodes and implantable pulse generator used, stimulation parameters chosen), and safety data.

This research should provide an update on practices, an evaluation of the efficacy and long term safety of occipital nerves stimulation, and perhaps help in identifying response predictive factors to this neuromodulation approach.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Cross Sectional

入排标准

性别
All
接受健康志愿者

入选标准

  • patients suffering from refractory chronic headache disorders and treated by occipital nerves stimulation

排除标准

  • patients who don't agree with participating in the study because the ending of professional confidentiality is required for setting up the database

结局指标

主要结局

observation of a disease or medical condition under normal conditions

时间窗: at each visit (up to 4 years)

social and demographic data, medical data (headache features, headache functional and emotional impact, medications, and concomitant medical conditions), technical data (kind of electrodes and implantable pulse generator used, stimulation parameters chosen), and safety data.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (16)

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