ClinicalTrials.gg
CompletedNCT06410872RiCHUpdated May 13, 2024

Risk Taking and Decision-making in Cluster Headache Patients

An observational study in Cluster Headache, sponsored by Leiden University Medical Center. Completed at 1 site in Netherlands. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-05-13.

Sponsored by Leiden University Medical Center · Observational

Study type
Observational
Model
Case-control
Time perspective
Cross-sectional
Enrollment
140
Ages
18 Years to 65 Years
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Cluster Headache

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03

In context

Cluster Headache

123 studies on the registry are indexed under Cluster Headache; 26 are open to participants now.

This study's enrollment of 140 is above the median of 68 across 32 observational studies indexed under Cluster Headache.

Browse Cluster Headache studies →

Lead sponsor

Leiden University Medical Center is the lead sponsor of 334 studies on the registry; 110 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
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Study design

Observational model
Case-control
Time perspective
Cross-sectional
Enrollment
140 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

  • Diagnostic testBART 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)

    Also known as: Questionnaires

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What researchers measure

Primary outcomes

  1. Difference in mean total score on the Zuckerman Sensation Seeking Scale between groups

    Between group difference

    Time frame: One time-point

  2. Difference in mean total number of pumps during second trial between groups

    Between group difference

    Time frame: One time-point

Secondary outcomes

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

    Between group difference

    Time frame: One time-point

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

    Average # of pumps, Exploded Balloons

    Time frame: One time-point

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Study locations

1 site
  • LUMC
    Leiden, Zuid Holland, Netherlands
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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Apr 2019 to primary completion in Jan 2022, 32 months.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 8, 2019
First posted
May 13, 2024
StartActual
Apr 23, 2019
Primary completionActual
Jan 1, 2022
CompletionActual
Jan 1, 2022
Last update
May 13, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 13, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06410872
Responsible party
RolfFronczek (MD, PhD, Leiden University Medical Center) — Principal investigator
First posted
May 13, 2024
Start date
Apr 23, 2019
Primary completion
Jan 1, 2022
Completion
Jan 1, 2022
Last update
May 13, 2024

Study contacts

Rolf Fronczek, MD / PhD
principal investigator · Neurologist LUMC

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2024. You cannot join it, but the record below documents what was studied.

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