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

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.

Study Overview

• Status: Unknown
• Conditions: Cluster Headache
• Intervention / Treatment: Diagnostic test: MRI examination

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 Type: Observational
• Enrollment (Anticipated): 60

Contacts and Locations

• Study Contact: Name: Heiko Pohl, MD; Phone Number: +41 44 255 1856; Email: heiko.pohl@usz.ch

Study Locations

• Switzerland
  • Zurich
    • Zürich, Zurich, Switzerland, 8091
      • Recruiting
      • University Hospital Zurich
      • Contact: Heiko Pohl, MD; Phone Number: +41 44 255 1856; Email: heiko.pohl@usz.ch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients suffering from cluster headache.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Diagnostic test: MRI examination; 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.; Other Names: quantitative sensory testing (QST)
Control group; Participants not suffering from cluster headache will be included in this group.	Diagnostic test: MRI examination; 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.; Other Names: quantitative sensory testing (QST)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Circadian rhythmicity of the functional connectivity of the brain	Changes from baseline in functional connectivity of the brain using whole-brain fMRI	Measurements will be made at noon and at 1 a.m. (+/- 2 hours); we will compare these measurements to identify changes.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Circadian rhythmicity of the pain threshold	Changes from baseline of the pain threshold in the face using quantitative sensory testing (QST)	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	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)	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	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	Measurements will be made at noon and at 1 a.m. (+/- 2 hours); we will compare these measurements to identify changes.

Collaborators and Investigators

• Sponsor: University of Zurich
• Investigators: Principal Investigator: Heiko Pohl, MD, University of Zurich

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 26, 2019
• Primary Completion (ANTICIPATED): June 30, 2020
• Study Completion (ANTICIPATED): June 30, 2020

Study Registration Dates

• First Submitted: June 26, 2019
• First Submitted That Met QC Criteria: May 26, 2020
• First Posted (ACTUAL): June 1, 2020

Study Record Updates

• Last Update Posted (ACTUAL): June 1, 2020
• Last Update Submitted That Met QC Criteria: May 26, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Keywords: functional connectivity; Primary Headache; Trigeminal autonomic cephalgia
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Headache Disorders, Primary; Headache Disorders; Trigeminal Autonomic Cephalalgias; Headache; Cluster Headache
• Other Study ID Numbers: 2018-02389

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No