Cluster HeadacheNCT04409977
Circadian Changes of the Hypothalamic Activity in Patients Suffering From Cluster Headache
An observational study of Cluster Headache, run by University of Zurich at 1 site in Switzerland.
Trial summary
Cluster headache attacks do not occur randomly throughout the day, but have a clear circadian rhythmicity. The aim of this study is to investigate circadian changes of the brain, the autonomic nervous system and pain processing systems. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Cluster Headache
- What is being tested?
- MRI examination
- How many people
- 60 participants
- Where
- 1 siteSwitzerland
- Study dates
- 26 Jun 2019to 30 Jun 2020
- 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 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients suffering from cluster headache.
Who may be able to join
- Diagnosis of cluster headache (CH) may enter the patient group, patients not suffering from CH may enter the control group.
- knowledge of the german language suffices to understand the information sheet and consent form
- having read, understood and signed the consent form
Who cannot join
- Pregnancy
- contraindications for the MRI scan (particularly metal splinters, ferromagnetic devices and implants)
- claustrophobia
- obesity (MRI > 35 kg/m2)
- shift working (last night shift must date back more than one week)
- jet lag (last travel over more than two time zones must date back more than one week)
Trial locations and contacts
1 site in 1 country.
Switzerland1 site, 1 recruiting
- Recruiting
University hospital Zurich
Zurich, Canton of Zurich, 8091
Heiko Pohl, MD, +41 44 255 1856, heiko.pohl@usz.ch
About this study
Cluster headache attacks do not occur randomly throughout the day, but have a clear circadian rhythmicity. The aim of this study is to investigate circadian changes of the brain, the autonomic nervous system and pain processing systems.
Read the detailed description
Cluster headache attacks do not occur randomly throughout the day, but have a clear circadian rhythmicity. The aim of this study is to investigate circadian changes in the functional connectivity, spectroscopy, iron deposition and perfusion of the brain. In addition, we plan to investigate circadian changes in the pain threshold of the brain using quantitative sensory testing (QST). Finally, we will investigate changes in the autonomic nervous system measuring the pupillary response.
- Conditions
- Cluster Headache
- Being tested
- MRI examination
- Keywords
- Primary Headache, Trigeminal autonomic cephalgia, functional connectivity
- Medical subject headings
- Cluster Headache, Trigeminal Autonomic Cephalalgias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRI examinationDiagnostic test
Also called quantitative sensory testing (QST)
Patient will be scanned in the MRI twice, once at noon (+/- 1 hour), once at 1 a.m. (+/- 1 hour). The investigators will search for any changes in functional connectivity, particular regarding the connection between the hypothalamus and pain-processing networks.
| Study group | Role | What they receive |
|---|---|---|
| Patient group | Patients suffering from cluster headache will be included in this group. When analysing the data, the investigators will distinguish those in the in-bout period from those in the out-bout period. People in this group may participate twice: once in the in-bout and once in the out-bout period. Receives: Diagnostic Test: MRI examination | |
| Control group | Participants not suffering from cluster headache will be included in this group. Receives: Diagnostic Test: MRI examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Circadian rhythmicity of the functional connectivity of the brain
Changes from baseline in functional connectivity of the brain using whole-brain fMRI
Measured: Measurements will be made at noon and at 1 a.m. (+/- 2 hours); we will compare these measurements to identify changes.
Secondary outcomes (5)
Circadian rhythmicity of the pain threshold
Changes from baseline of the pain threshold in the face using quantitative sensory testing (QST)
Measured: Measurements will be made at noon and at 1 a.m. (+/- 2 hours); we will compare these measurements to identify changes.
Circadian changes in the perfusion of the brain.
Changes from baseline in perfusion of the brain using Arterial Spin Labeled MRI Perfusion Imaging and vascular space occupancy sequences
Measured: Measurements will be made at noon and at 1 a.m. (+/- 2 hours); we will compare these measurements to identify changes.
Circadian rhythmicity of the autonomic system
Changes from baseline in the pupillary response (measured using pupillometry)
Measured: Measurements will be made at noon and at 1 a.m. (+/- 2 hours); we will compare these measurements to identify changes.
Circadian rhythmicity of the spectroscopy of the hypothalamus
Changes from baseline in the spectroscopy of the hypothalamus
Measured: Measurements will be made at noon and at 1 a.m. (+/- 2 hours); we will compare these measurements to identify changes.
Circadian rhythmicity of the spectroscopy of the hypothalamus
Changes from baseline in the iron concentration of the brain using quantitative susceptibility mapping
Measured: Measurements will be made at noon and at 1 a.m. (+/- 2 hours); we will compare these measurements to identify changes.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2020
- Study start26 Jun 2019
- Primary completion30 Jun 2020 (estimated)
- Study completion30 Jun 2020 (estimated)
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.
- More trials run by University of ZurichThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Heiko Pohl, MD, Principal investigator, University of Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04409977
- Sponsor's protocol ID
- 2018-02389
- Other IDs
- 2018
- Status last verified
- May 2020
- First submitted
- 26 Jun 2019
- Last updated
- 1 Jun 2020
- 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 1 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Circadian Changes of the Hypothalamic Activity in Patients Suffering From Cluster Headache
- ClinicalTrials.gov ID
- NCT04409977
- Acronym / sponsor ID
- 2018-02389
- Conditions
- Cluster Headache
- Keywords
- Primary Headache, Trigeminal autonomic cephalgia, functional connectivity
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- 26 Jun 2019 (actual)
- Primary completion
- 30 Jun 2020 (estimated)
- Study completion
- 30 Jun 2020 (estimated)
- First posted
- 1 Jun 2020 (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.
Cluster headache attacks do not occur randomly throughout the day, but have a clear circadian rhythmicity. The aim of this study is to investigate circadian changes of the brain, the autonomic nervous system and pain processing systems.
Detailed description
Cluster headache attacks do not occur randomly throughout the day, but have a clear circadian rhythmicity. The aim of this study is to investigate circadian changes in the functional connectivity, spectroscopy, iron deposition and perfusion of the brain. In addition, we plan to investigate circadian changes in the pain threshold of the brain using quantitative sensory testing (QST). Finally, we will investigate changes in the autonomic nervous system measuring the pupillary response.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient group | – | Diagnostic Test: MRI examinationPatients suffering from cluster headache will be included in this group. When analysing the data, the investigators will distinguish those in the in-bout period from those in the out-bout period. People in this group may participate twice: once in the in-bout and once in the out-bout period. |
| Control group | – | Diagnostic Test: MRI examinationParticipants not suffering from cluster headache will be included in this group. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients suffering from cluster headache.
Key inclusion criteria (3 listed)
- Diagnosis of cluster headache (CH) may enter the patient group, patients not suffering from CH may enter the control group.
- knowledge of the german language suffices to understand the information sheet and consent form
- having read, understood and signed the consent form
Key exclusion criteria (6 listed)
- Pregnancy
- contraindications for the MRI scan (particularly metal splinters, ferromagnetic devices and implants)
- claustrophobia
- obesity (MRI > 35 kg/m2)
- shift working (last night shift must date back more than one week)
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 |
|---|---|---|
| MRI examinationAlso: quantitative sensory testing (QST)Patient will be scanned in the MRI twice, once at noon (+/- 1 hour), once at 1 a.m. (+/- 1 hour). The investigators will search for any changes in functional connectivity, particular regarding the connection between the hypothalamus and pain-processing networks. | Diagnostic test | Control group, Patient group |
Primary outcome
Circadian rhythmicity of the functional connectivity of the brain
Time frame: Measurements will be made at noon and at 1 a.m. (+/- 2 hours); we will compare these measurements to identify changes.
Changes from baseline in functional connectivity of the brain using whole-brain fMRI
5 secondary outcomes
Circadian rhythmicity of the pain threshold
Time frame: Measurements will be made at noon and at 1 a.m. (+/- 2 hours); we will compare these measurements to identify changes.
Circadian changes in the perfusion of the brain.
Time frame: Measurements will be made at noon and at 1 a.m. (+/- 2 hours); we will compare these measurements to identify changes.
Circadian rhythmicity of the autonomic system
Time frame: Measurements will be made at noon and at 1 a.m. (+/- 2 hours); we will compare these measurements to identify changes.
Circadian rhythmicity of the spectroscopy of the hypothalamus
Time frame: Measurements will be made at noon and at 1 a.m. (+/- 2 hours); we will compare these measurements to identify changes.
Circadian rhythmicity of the spectroscopy of the hypothalamus
Time frame: Measurements will be made at noon and at 1 a.m. (+/- 2 hours); we will compare these measurements to identify changes.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2020.
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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.
Heiko Pohl, MD principal investigator
University of Zurich
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 University of Zurich at 1 site in Switzerland.
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 6 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: status not confirmed, as of the sponsor's last update on 1 Jun 2020. 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 Switzerland. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Heiko Pohl, MD (+41 44 255 1856, heiko.pohl@usz.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Circadian rhythmicity of the functional connectivity of the brain (time frame: Measurements will be made at noon and at 1 a.m. (+/- 2 hours); we will compare these measurements to identify changes.). 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 1 Jun 2020.