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临床试验/NCT04585698
NCT04585698Unknown不适用

Quantitative Sensory Testing, Blink Reflex and Nociceptive Flexion Reflex in the Pathophysiology of Headache

University of Liege0 个研究点目标入组 40 人开始时间: 2020年10月最近更新:
适应症

试验速览

阶段
不适用
入组人数
40
主要终点
modulation of pain threshold by fremanezumab

研究概览

简要总结

The aim of this study is to compare central and peripheric sensitization in headache patients at Baseline (T0) and 1 month after (T1) a treatment with an anti-CGRP (Fremanezumab-Ajovy).

详细描述

20 patients and 20 healthy subjects will be enrolled. The headache patients will be recruited just before starting their treatment and 1 month after (corresponding to the efficacy peak). Hot and cold stimulations will be delivered with the ATS probe from the Medoc Pathway on the forehead and on the hand (palmar face) to determine painful threshold to warm/cold stimuli. A blink reflex will be generated with a concentric electrode placed over the eyebrow and with active/earth electrodes linked to the EMG machine for the recording. For the nociceptive flexion reflex, a cutaneous stimulation will be applied on the arm and the response recorded on the corresponding muscles.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • patients with headache which are about to receive a treatment with fremanezumab

排除标准

  • medication changes 1 month prior to the test
  • neuropathy
  • acute or chronic pain
  • medications having effects on the central nervous system
  • other disease

结局指标

主要结局

modulation of pain threshold by fremanezumab

时间窗: one year

Blink reflex and nociceptive flexion reflex usig EMG Viking Viasys.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Manise Maite

Doctor in Medical Sciences

University of Liege

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