Risk Taking and Decision-making in Cluster Headache Patients

NCT06410872 | Completed

• 1 other identifier: NL68327
• Study Type: observational
• Target: 140
• Locations: 1 country
• Sites: 1

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.

Conditions

Cluster Headache

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

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

  One time-point

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

  One time-point

Study Arms (4)

Episodic cluster headache

Patients diagnosed according to ICHD3 criteria with episodic cluster headache

Diagnostic Test: BART Task

Chronic cluster headache

Patients diagnosed according to ICHD3 criteria with chroniccluster headache

Diagnostic Test: BART Task

Migraine

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

Diagnostic Test: BART Task

Healthy controls

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

Diagnostic Test: BART Task

Interventions

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)

Also known as: Questionnaires

Chronic cluster headache; Episodic cluster headache; Healthy controls; Migraine

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Leiden University Medical Center: lead

Study Sites (1)

LUMC

Leiden, South Holland, Netherlands

Location

MeSH Terms

Conditions

Cluster Headache

Condition Hierarchy (Ancestors)

Trigeminal Autonomic Cephalalgias; Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Rolf Fronczek, MD / PhD

  Neurologist LUMC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: October 8, 2019
• First Posted: May 13, 2024
• Study Start: April 23, 2019
• Primary Completion: January 1, 2022
• Study Completion: January 1, 2022
• Last Updated: May 13, 2024

Record last verified: 2024-05

Locations

NL (1)