Clinical trial NCT04409977: Circadian Changes of the Hypothalamic Activity in Patients Suffering From Cluster Headache
Official title: Circadian Changes of the Hypothalamic Activity in Patients Suffering From Cluster Headache
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cluster Headache
Keywords: Primary Headache
Trigeminal autonomic cephalgia
functional connectivity
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2020-06-01
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients suffering from cluster headache.

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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)

Primary outcomes:
measure: Circadian rhythmicity of the functional connectivity of the brain
timeFrame: Measurements will be made at noon and at 1 a.m. (+/- 2 hours); we will compare these measurements to identify changes.
Secondary outcomes:
measure: Circadian rhythmicity of the pain threshold
timeFrame: Measurements will be made at noon and at 1 a.m. (+/- 2 hours); we will compare these measurements to identify changes.
measure: Circadian changes in the perfusion of the brain.
timeFrame: Measurements will be made at noon and at 1 a.m. (+/- 2 hours); we will compare these measurements to identify changes.
measure: Circadian rhythmicity of the autonomic system
timeFrame: Measurements will be made at noon and at 1 a.m. (+/- 2 hours); we will compare these measurements to identify changes.
measure: Circadian rhythmicity of the spectroscopy of the hypothalamus
timeFrame: Measurements will be made at noon and at 1 a.m. (+/- 2 hours); we will compare these measurements to identify changes.
measure: Circadian rhythmicity of the spectroscopy of the hypothalamus
timeFrame: Measurements will be made at noon and at 1 a.m. (+/- 2 hours); we will compare these measurements to identify changes.
Other outcomes:
Locations:
city: Zürich
country: Switzerland
facility: University hospital Zurich
state: Zurich
Study officials:
affiliation: University of Zurich
name: Heiko Pohl, MD
role: PRINCIPAL_INVESTIGATOR
References: