Neurophysiological Characterization of Treatment Response Following the Initiation of Prophylactic Therapy in Episodic Migraine
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- nociceptive blink reflex habituation
研究概览
简要总结
This study aims to improve the pathophysiological understanding of migraine in in a longitudinal observational study investigating changes of established neurophysiological and imaging parameters in line with changes of the clinical phenotype.
The study's focus is the investigation of mechanisms that are directly related to the cyclic character of migraine and its core structures. In this context, the primary endpoint is a change in the nociceptive blink reflex, an established brain stem reflex to study the trigemino-spinal system, associated with changes in migraine frequency and severity. In order to reliably detect changes in the trigeminal pain system, investigations are performed in patients before starting a prophylactic therapy and 3 months afterwards. Several secondary endpoints are used to evaluate changes of multimodal sensory and cortical information processing. Cerebral imaging will include examinations of structural and network effects of altered migraine disease activity.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Episodic Migraine
干预措施: antibodies against calcitonin-gene related peptide or its receptor (Drug)
结局指标
主要结局
nociceptive blink reflex habituation
时间窗: baseline and after 3 months
habituation of the area under of the curve of the R2 blink reflex component on the side primarily affected by migraine headaches
次要结局
- nociceptive blink reflex area(baseline and after 3 months)
- somatosensory evoked potentials (SSEP)(baseline and after 3 months)
- pattern-reversal visual evoked potentials (VEP)(baseline and after 3 months)
- migraine headache frequency(baseline and after 3 months)
- headache impact test (HIT-6)(baseline and after 3 months)
- migraine disability assessment (MIDAS)(baseline and after 3 months)
- Patient-Reported Outcomes Measurement Information System Profile 29 (PROMIS-29)(baseline and after 3 months)
