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

Cluster Headache Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04409977
• Other study ID #: 2018-02389
• Status: Recruiting
• Start date: June 26, 2019
• Est. completion date: June 30, 2020

Study information

• Verified date: May 2020
• Source: University of Zurich
• Contact: Heiko Pohl, MD
• Phone: +41 44 255 1856
• Email: heiko.pohl[@]usz.ch
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: June 30, 2020
• Est. primary completion date: June 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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)

Related Conditions & MeSH terms

• Cluster Headache
• Headache

Intervention

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.

Locations

Country	Name	City	State
Switzerland	University hospital Zurich	Zürich	Zurich

Sponsors (1)

Lead Sponsor	Collaborator
University of Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.