Risk Taking and Decision-making in Cluster Headache Patients

Completed

• Conditions: Cluster Headache
• Interventions: Diagnostic Test: BART Task

• Registration Number: NCT06410872
• Lead Sponsor: Leiden University Medical Center

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2019-04-23
• Study First Submitted: 2019-10-08
• Primary Completion: 2022-01-01
• Study Completion: 2022-01-01
• Status Verified: 2024-05
• Study First Submitted QC: 2024-05-08
• Last Update Submitted: 2024-05-08
• Study First Posted: 2024-05-13
• Last Update Posted: 2024-05-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 140

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Migraine	BART Task	Patients diagnosed according to ICHD3 criteria with migraine (MA and MO)
Episodic cluster headache	BART Task	Patients diagnosed according to ICHD3 criteria with episodic cluster headache
Chronic cluster headache	BART Task	Patients diagnosed according to ICHD3 criteria with chroniccluster headache
Healthy controls	BART Task	Healthy controls, sex- and age-matched without current diagnosis of headache disorder

Primary Outcome Measures

Name	Time	Method
Difference in mean total score on the Zuckerman Sensation Seeking Scale between groups	One time-point	Between group difference
Difference in mean total number of pumps during second trial between groups	One time-point	Between group difference

Secondary Outcome Measures

Name	Time	Method
Difference in mean scores on the BART between groups and between the first and second BART within groups	One time-point	Average # of pumps, Exploded Balloons
Difference in mean scores on the array of psychometric tests between groups	One time-point	Between group difference

Trial Locations

Locations (1)

LUMC; 🇳🇱 Leiden, Zuid Holland, Netherlands