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临床试验/NCT06410872
NCT06410872已完成不适用

Risk Taking and Decision-making in Cluster Headache Patients

Leiden University Medical Center1 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2019年4月23日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
140
试验地点
1
主要终点
Difference in mean total score on the Zuckerman Sensation Seeking Scale between groups

研究概览

简要总结

Since there is conflicting and insufficient data regarding CH personality and addictive behaviour, the investigators will investigate risk- and reward seeking behaviour in people with cluster headache. If an increased tendency towards this behaviour is shown, it will add to the clinical knowledge of cluster headache and possible lead to insights in a common biological susceptibility.

详细描述

Cluster headache is a severe primary headache disorder. In clinical anecdotes, people with cluster headache frequently report use of tobacco and illicit drugs. Furthermore, addictive behaviours and tattoos are considered to be more common in people with cluster headache than in the general population. The causality of these associations remains unclear. A common biological susceptibility has been proposed, predisposing people to both addictive behaviour and cluster headache. On the other hand, a role of illicit drug exposure in cluster headache pathophysiology has been suggested. The increased use of tobacco and illicit drugs could also reflect attempts to treat cluster headache attacks. In this explorative study the investigators will assess both subjective and objective measures reflecting addictive behaviour and risk- and reward seeking in cluster headache. This will add to the clinical knowledge of cluster headache and possible lead to insights in a common biological susceptibility.

研究设计

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

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

  • Age 18-64 years
  • Normal or corrected vision with acuity up to 20/60
  • Presence of episodic (n=35) or chronic (n=35) cluster headache or migraine with or without arua (n=35), diagnosed according to the International Classification of Headache Disorders criteria, 3rd edition (ICHD-3, 3.1.1)

排除标准

  • Diagnosis of uncorrected visual problems (myopia/presbiopia, peripheral vision problems or legal blindness)
  • Current diagnosis of generalized anxiety disorder, depression or other psychiatric illness
  • Other acute, unstable medical conditions or serious chronic diagnoses

结局指标

主要结局

Difference in mean total score on the Zuckerman Sensation Seeking Scale between groups

时间窗: One time-point

Between group difference

Difference in mean total number of pumps during second trial between groups

时间窗: One time-point

Between group difference

次要结局

  • Difference in mean scores on the array of psychometric tests between groups(One time-point)
  • Difference in mean scores on the BART between groups and between the first and second BART within groups(One time-point)

研究者

发起方
Leiden University Medical Center
申办方类型
Other
责任方
Principal Investigator
主要研究者

RolfFronczek

MD, PhD

Leiden University Medical Center

研究点 (1)

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