Risk Taking and Decision-making in Cluster Headache Patients (RiCH)

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.

Study Overview

• Status: Completed
• Conditions: Cluster Headache
• Intervention / Treatment: Diagnostic test: BART Task

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 Type: Observational
• Enrollment (Actual): 140

Contacts and Locations

Study Locations

• Netherlands
  • Zuid Holland
    • Leiden, Zuid Holland, Netherlands
      • LUMC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Leiden University Medical Center
• Investigators: Principal Investigator: Rolf Fronczek, MD / PhD, Neurologist LUMC

Study record dates

Study Major Dates

• Study Start (Actual): April 23, 2019
• Primary Completion (Actual): January 1, 2022
• Study Completion (Actual): January 1, 2022

Study Registration Dates

• First Submitted: October 8, 2019
• First Submitted That Met QC Criteria: May 8, 2024
• First Posted (Actual): May 13, 2024

Study Record Updates

• Last Update Posted (Actual): May 13, 2024
• Last Update Submitted That Met QC Criteria: May 8, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Headache Disorders, Primary; Headache Disorders; Trigeminal Autonomic Cephalalgias; Headache; Cluster Headache
• Other Study ID Numbers: NL68327

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No