Clinical trial NCT06410872: Risk Taking and Decision-making in Cluster Headache Patients
Official title: Risk Taking and Decision-making in Cluster Headache Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cluster Headache
Lead sponsor: Leiden University Medical Center
Sponsor class: OTHER
First posted: 2024-05-13
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: People with episodic (n=35) and chronic cluster headache (n=35) will be recruited from the Neurology outpatient clinic of Leiden University Medical Centre. Migraineurs (n=35) will be recruited from the LUMINA pool from people with migraine who have previously expressed interest in being contacted for future studies. Healthy controls (n=35) will be recruited from a pool of prior research-study participants, who have previously expressed interest in being contacted for future studies. We aim to achieve a 3:1 male:female ratio.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Difference in mean total score on the Zuckerman Sensation Seeking Scale between groups
timeFrame: One time-point
measure: Difference in mean total number of pumps during second trial between groups
timeFrame: One time-point
Secondary outcomes:
measure: Difference in mean scores on the array of psychometric tests between groups
timeFrame: One time-point
measure: Difference in mean scores on the BART between groups and between the first and second BART within groups
timeFrame: One time-point
Other outcomes:
Locations:
city: Leiden
country: Netherlands
facility: LUMC
state: Zuid Holland
Study officials:
affiliation: Neurologist LUMC
name: Rolf Fronczek, MD / PhD
role: PRINCIPAL_INVESTIGATOR
References: