Evolution of the Cognitive Profile and Quality of Life of Adult Patients Suffering From Severe Migraines Under Preventive Treatment (CEREB)
In chronic migraine, we routinely use innovative treatments such as peri-cranial injections of botulinum toxin type A according to the PREEMPT protocol, or intravenous Eptinezumab, both targeting the Calcitonin Gene-Related Peptide (CGRP). We observe significant improvement in 70-80% of our patients after one year of treatment, corresponding to at least a 30-50% reduction in the number of migraines per month, together with improvements in anxiety and depression comorbidities (HADS), catastrophizing scores (PCS), and the impact of migraines on quality of life (HIT-6).
Our main hypothesis, based on our clinical experience and the literature, is that the cognitive profile of these adult patients-particularly attention and memory, as assessed by a validated self-report questionnaire-improves following treatment with botulinum toxin type A administered according to the PREEMPT protocol or intravenous anti-CGRP antibody infusions (Eptinezumab), alongside improvement in migraine disease activity (number of migraines per month), after one year of treatment.
研究概览
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名:Eric SALVAT, MD
- 电话号码:0033 03 88 12 51 18
- 邮箱:eric.salvat@chru-strasbourg.fr
学习地点
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Strasbourg、法国、67091
- Hopitaux Universitaires de Strasbourg
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接触:
- Eric SALVAT, MD
- 电话号码:0033 03 88 12 51 18
- 邮箱:eric.salvat@chru-strasbourg.fr
-
-
参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
Inclusion Criteria:
Adult patient (legal age) Adult patient suffering from severe treatment-resistant migraine, according to the ICHD-3 criteria, i.e. more than 8 migraine days per month (high-frequency episodic migraine and chronic migraine) Headache condition indicating treatment with botulinum toxin type A according to the PREEMPT protocol or infusion of anti-CGRP antibodies (Eptinezumab) Subject affiliated with a social health insurance scheme Subject able to understand the objectives and risks related to the research and able to provide informed, dated, and signed consent
Exclusion Criteria:
Patient suffering from a central neurological disorder or sequelae (multiple sclerosis, traumatic brain injury with loss of consciousness, stroke, dementia, etc.) Patient suffering from another chronic pain condition (fibromyalgia, low back pain, etc.) Patient suffering from a psychiatric disorder other than anxiety-depressive syndrome Patient suffering from severe disabling auditory or visual impairment, such as profound hearing loss not correctable with hearing aids or blindness
Contraindication to the treatment prescribed as part of routine care:
Botulinum toxin type A: pregnancy, allergic hypersensitivity, myasthenia gravis, Lambert-Eaton syndrome, infection at the injection site Eptinezumab: pregnancy, allergic hypersensitivity, severe cardiovascular disease (stroke, transient ischemic attack, myocardial infarction, coronary artery bypass surgery) Patient currently in an exclusion period (determined by a previous or ongoing study) Inability to provide the subject with informed information (emergency situation, comprehension difficulties, etc.) Subject under judicial protection Subject under guardianship or curatorship Pregnant or breastfeeding woman
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学习计划
研究是如何设计的?
设计细节
- 主要用途:卫生服务研究
- 分配:不适用
- 介入模型:单组作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的:migraine
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Test E-Miles - MoCA - MMSE
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研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
|---|---|
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E-MILE cognitive profile mapping
大体时间:Month12
|
Month12
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- RC26_0200
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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