Risk Taking and Decision-making in Cluster Headache Patients

NCT ID: NCT06410872

Last Updated: 2024-05-13

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 140 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-04-23
• Study Completion Date: 2022-01-01

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.

Conditions

Cluster Headache

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Episodic cluster headache

Patients diagnosed according to ICHD3 criteria with episodic cluster headache

BART Task

Intervention Type: 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)

Chronic cluster headache

Patients diagnosed according to ICHD3 criteria with chroniccluster headache

BART Task

Intervention Type: 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)

Migraine

Patients diagnosed according to ICHD3 criteria with migraine (MA and MO)

BART Task

Intervention Type: 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)

Healthy controls

Healthy controls, sex- and age-matched without current diagnosis of headache disorder

BART Task

Intervention Type: 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)

Interventions

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)

Intervention Type: DIAGNOSTIC_TEST

Other Intervention Names

Questionnaires

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Leiden University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

RolfFronczek

MD, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rolf Fronczek, MD / PhD

Role: PRINCIPAL_INVESTIGATOR

Neurologist LUMC

Locations

LUMC

Leiden, South Holland, Netherlands

Countries

Netherlands

Other Identifiers

NL68327

Identifier Type: -

Identifier Source: org_study_id