MedPath

Circadian Changes of the Hypothalamic Activity in Patients Suffering From Cluster Headache

Conditions
Cluster Headache
Interventions
Diagnostic Test: MRI examination
Registration Number
NCT04409977
Lead Sponsor
University of Zurich
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.

Recruitment & Eligibility

Status
UNKNOWN
Sex
All
Target Recruitment
60
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)

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
Control groupMRI examinationParticipants not suffering from cluster headache will be included in this group.
Patient groupMRI 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.
Primary Outcome Measures
NameTimeMethod
Circadian rhythmicity of the functional connectivity of the brainMeasurements 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

Secondary Outcome Measures
NameTimeMethod
Circadian rhythmicity of the autonomic systemMeasurements will be made at noon and at 1 a.m. (+/- 2 hours); we will compare these measurements to identify changes.

Changes from baseline in the pupillary response (measured using pupillometry)

Circadian changes in the perfusion of the brain.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 perfusion of the brain using Arterial Spin Labeled MRI Perfusion Imaging and vascular space occupancy sequences

Circadian rhythmicity of the spectroscopy of the hypothalamusMeasurements will be made at noon and at 1 a.m. (+/- 2 hours); we will compare these measurements to identify changes.

Changes from baseline in the iron concentration of the brain using quantitative susceptibility mapping

Circadian rhythmicity of the pain thresholdMeasurements will be made at noon and at 1 a.m. (+/- 2 hours); we will compare these measurements to identify changes.

Changes from baseline of the pain threshold in the face using quantitative sensory testing (QST)

Trial Locations

Locations (1)

University hospital Zurich

🇨🇭

Zürich, Zurich, Switzerland

© Copyright 2025. All Rights Reserved by MedPath