Cluster Headache, Addictions and Vascular Function

Study Overview
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Brief Summary
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Cluster headache (CH) is one of the most painful primitive headaches. Developments in neuroimaging have demonstrated activation of the ipsilateral hypothalamic and orexinergic system, which is similar in patients with addictions. CH has strong links to the vascular system but there is no study measuring endothelial function in CH sufferers.

Detailed Description
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Several studies have shown an association between Cluster headache (CH) and smoking. However, no data exists on the link between CH and other addictions, and impact of these addictions on clinical characteristics of the disease. In addition, despite the strong biological link between CH and the vascular system, systematic investigations about vascular functions in CH patients are lacking. This will be a prospective cohort study of 150 patients with CH, conducted in the Headache Center in Bordeaux, France.

Official Title
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Cluster Headache (CH), Addictions and Vascular Function

Conditions
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Cluster Headache

Intervention / Treatment
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* Other: Neurological clinical examination
* Other: Psychological clinical examination
* Other: Questionnaires
* Other: Blood sample
* Other: Endothelial function measurement


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Presenting a chronic or episodic cluster headache diagnosed according to the International Classification of Headache Disorders (ICH-D III) criteria, in active or inactive phase. Exclusion Criteria: Other primary headaches Subjects without social insurance

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patient with Cluster headache<br>Prospective follow-up of patient with Cluster headache | Other: Neurological clinical examination<br>* Diagnostic and description of cluster headache<br>Other: Psychological clinical examination<br>* Scale and questionnaires<br>Other: Questionnaires<br>* Psychopathological and cognitive questionnaires<br>Other: Blood sample<br>* Blood sample for DNA collection<br>Other: Endothelial function measurement<br>* Endothelial function will be measured with a noninvasive Peripheral Arterial Tone (PAT) signal technology using the EndoPAT device<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of active periods of cluster headache |  | Day 0 (Inclusion visit) | 
| Number of active periods |  | Day 0 (Inclusion visit) | 
| Duration of cluster headache |  | Day 0 (Inclusion visit) | 
| Severity of attacks |  | Day 0 (Inclusion visit) | 
| Duration of active periods of cluster headache |  | one year after inclusion | 
| Number of active periods |  | one year after inclusion | 
| Duration of cluster headache |  | one year after inclusion | 
| Severity of attacks |  | one year after inclusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Existence of an addiction |  | Day 0 (Inclusion visit) | 
| Existence of an addiction |  | One year after inclusion | 
| Severity of Addiction |  | Day 0 (Inclusion visit) | 
| Severity of Addiction |  | One year after inclusion | 
| Reactive Hyperemic Index (RHI) | Endothelial function measurement | Day 0 (Inclusion visit) |