Cluster HeadacheRiCHNCT06410872
Risk Taking and Decision-making in Cluster Headache Patients
An observational study of Cluster Headache, run by Leiden University Medical Center at 1 site in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Cluster Headache
- What is being tested?
- BART Task
- How many people
- 140 participants
- Where
- 1 siteNetherlands
- Study dates
- 23 Apr 2019to 1 Jan 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Cluster Headache
- Being tested
- BART Task
- Medical subject headings
- Cluster Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BART TaskDiagnostic test
Also called Questionnaires
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)
| Study group | Role | What they receive |
|---|---|---|
| Episodic cluster headache | Patients diagnosed according to ICHD3 criteria with episodic cluster headache Receives: Diagnostic Test: BART Task | |
| Chronic cluster headache | Patients diagnosed according to ICHD3 criteria with chroniccluster headache Receives: Diagnostic Test: BART Task | |
| Migraine | Patients diagnosed according to ICHD3 criteria with migraine (MA and MO) Receives: Diagnostic Test: BART Task | |
| Healthy controls | Healthy controls, sex- and age-matched without current diagnosis of headache disorder Receives: Diagnostic Test: BART Task |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in mean total score on the Zuckerman Sensation Seeking Scale between groups
Between group difference
Measured: One time-point
Difference in mean total number of pumps during second trial between groups
Between group difference
Measured: One time-point
Secondary outcomes (2)
Difference in mean scores on the array of psychometric tests between groups
Between group difference
Measured: 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
Measured: One time-point
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2024
- Study start23 Apr 2019
- Primary completion1 Jan 2022
- Study completion1 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cluster HeadacheStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Leiden University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, RolfFronczek, Leiden University Medical Center
- Investigators
- Rolf Fronczek, MD / PhD, Principal investigator, Neurologist LUMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06410872
- Sponsor's protocol ID
- NL68327
- Acronym
- RiCH
- Status last verified
- May 2024
- First submitted
- 8 Oct 2019
- Last updated
- 13 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Taking and Decision-making in Cluster Headache Patients
- ClinicalTrials.gov ID
- NCT06410872
- Acronym / sponsor ID
- RiCH / NL68327
- Conditions
- Cluster Headache
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Leiden University Medical CenterUniversity, hospital or other
- Study start
- 23 Apr 2019 (actual)
- Primary completion
- 1 Jan 2022 (actual)
- Study completion
- 1 Jan 2022 (actual)
- First posted
- 13 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Episodic cluster headache | – | Diagnostic Test: BART TaskPatients diagnosed according to ICHD3 criteria with episodic cluster headache |
| Chronic cluster headache | – | Diagnostic Test: BART TaskPatients diagnosed according to ICHD3 criteria with chroniccluster headache |
| Migraine | – | Diagnostic Test: BART TaskPatients diagnosed according to ICHD3 criteria with migraine (MA and MO) |
| Healthy controls | – | Diagnostic Test: BART TaskHealthy controls, sex- and age-matched without current diagnosis of headache disorder |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BART TaskAlso: QuestionnairesThe 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) | Diagnostic test | Chronic cluster headache, Episodic cluster headache, Healthy controls, Migraine |
Primary outcome
Difference in mean total score on the Zuckerman Sensation Seeking Scale between groups
Time frame: One time-point
Between group difference
Difference in mean total number of pumps during second trial between groups
Time frame: One time-point
Between group difference
2 secondary outcomes
Difference in mean scores on the array of psychometric tests between groups
Time frame: One time-point
Difference in mean scores on the BART between groups and between the first and second BART within groups
Time frame: One time-point
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rolf Fronczek, MD / PhD principal investigator
Neurologist LUMC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cluster Headache, run by Leiden University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in mean total score on the Zuckerman Sensation Seeking Scale between groups (time frame: One time-point). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2024.