NL-OMON46990已完成3 期
Occipital nerve stimulation in medically intractable, chronic cluster headache - ICO
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 120
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •ICHD-II criteria for Chronic Cluster Headache
- •Minimum mean attack frequency of 4 attacks per week
- •Minimum age of 18 years old
- •Signed study specific informed consent form agreeing to implantation of the device, data collection and follow-up requirements
- •Agreeing to refrain from starting new prophylactic CH medication, including steroids, or any other therapy aimed at CH (such as acupuncture, biofeedback, chiropractic, or massage) and agrees to maintain existing prophylactic CH medication from 4 weeks before entering the baseline period throughout the duration of the double blind phase of the study. It is allowed to change the dose of prophylactic medication during the study based on the opinion of the treating medical specialist.
- •Availability during follow-up period
- •An MRI not older than 4 years prior to enrolment must be available to exclude structural lesions potentially causing CCH. MRA of head and neck are to be performed according to study physician*s individual judgement.
- •Medically intractable (see below)
- •Adequate trial:
- •Appropriate dose and duration of treatment according to local guidelines, appropriate length of time, consideration of medication overuse;Failed:
- •No therapeutic or unsatisfactory effect, intolerable side effects, contraindications to use;Must have tried agents of at least three classes of the following, of which 1 and 2 are obligatory, and 1 should come from 3-5: (recommendation of Goadsby et al. applied to Dutch national guidelines);1 Verapamil
- •3 Methysergide
- •4 Topiramate
- •5 Gabapentin
排除标准
- •Other significant neurological or disabling diseases (including other forms of TAC) which in the opinion of the clinician may interfere with the study
- •Pregnancy or the wish to become pregnant during the study period
- •Cardiac pacemaker and other neuromodulatory devices
- •Psychiatric or cognitive disorders and/or behavioural problems which in the opinion of the clinician may interfere with the study
- •Taking CH prophylactic medication for conditions other than CH which in the opinion of the clinician may interfere with the study
- •Serious drug habituation and/or overuse of acute headache medication (use on 10 or more days per month) for other headaches than CH
- •Inability to complete the (electronic) diary in a sensible and accurate manner
- •Structural intracranial or cervical vascular lesions that may potentially cause CH
- •Previous destructive surgery involving the C2 or C3 roots (vertebrae) or trigeminal nerves
- •Enrolment in other clinical studies (of an investigational drug or device, new indication for an approved drug or device, or requirement of additional testing beyond standard clinical practice) during the study or within four weeks prior to his/her enrolment in the study
- •Requiring anticoagulation therapy or antithrombotic or thrombocyte aggregation-inhibitor for a concomitant condition that cannot be stopped peri-operatively. The local peri-operative protocol of each individual participating centre will be followed
研究者
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