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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Cluster Headache

Intervention / Treatment
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* Diagnostic Test: MRI examination


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patient group<br>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<br>* 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.<br>* Other names: quantitative sensory testing (QST);|
| Control group<br>Participants not suffering from cluster headache will be included in this group. | Diagnostic Test: MRI examination<br>* 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.<br>* Other names: quantitative sensory testing (QST);|

What is the study measuring?
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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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Primary Headache, Trigeminal autonomic cephalgia, functional connectivity