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OpenTrials
Completed

NCT Number: NCT06410872

Risk Taking and Decision-making in Cluster Headache Patients

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

LUMC

Leiden, South Holland, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)

Exclusion criteria

  • 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

Treatment and study plan

BART Task

Diagnostic Test

The Zuckerman's Sensation Seeking Scale version-V (SSS-V) - Four-factor score, The Barret Impulsiveness Scale (BIS), Gormally's Binge Eating Scale (BES), The World Health Organization-developed AUDIT (Alcohol Use Disorders Identification Test) screen, The CAGE questionnaire for substance abuse-adapted to include drugs, Gamblers Anonymous's 20 Questions (GA20), Hospital Anxiety and Depression Scale (HADS)

Other names: Questionnaires

Primary outcomes

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

    Time frame: One time-point

    Between group difference

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

    Time frame: One time-point

    Between group difference

Secondary outcomes

  1. Difference in mean scores on the array of psychometric tests between groups

    Time frame: One time-point

    Between group difference

  2. Difference in mean scores on the BART between groups and between the first and second BART within groups

    Time frame: One time-point

    Average # of pumps, Exploded Balloons

Sponsors and collaborators

Lead sponsor

Leiden University Medical Center

Other

Registry information

Acronym: RiCH

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
May 13, 2024
Registry last updated
May 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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