Risk Taking and Decision-making in Cluster Headache Patients

Cluster Headache Clinical Trial

— RiCH  

Official title:

Risk Taking and Decision-making in Cluster Headache Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06410872
• Other study ID #: NL68327
• Status: Completed
• Start date: April 23, 2019
• Est. completion date: January 1, 2022

Study information

• Verified date: May 2024
• Source: Leiden University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: January 1, 2022
• Est. primary completion date: January 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Cluster Headache
• Headache

Intervention

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)

Locations

Country	Name	City	State
Netherlands	LUMC	Leiden	Zuid Holland

Sponsors (1)

Lead Sponsor	Collaborator
Leiden University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference in mean total score on the Zuckerman Sensation Seeking Scale between groups	Between group difference	One time-point
Primary	Difference in mean total number of pumps during second trial between groups	Between group difference	One time-point
Secondary	Difference in mean scores on the array of psychometric tests between groups	Between group difference	One time-point
Secondary	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