Cluster Headache, Addictions and Vascular Function

Completed

• Conditions: Cluster Headache
• Interventions: Other: Neurological clinical examination; Other: Psychological clinical examination; Other: Questionnaires; Other: Blood sample; Other: Endothelial function measurement

• Registration Number: NCT02640105
• Lead Sponsor: University Hospital, Bordeaux

Brief Summary

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

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.

Study Timeline

• Study Start: 2014-06-25
• Study First Submitted: 2015-11-23
• Study First Submitted QC: 2015-12-21
• Study First Posted: 2015-12-28
• Primary Completion: 2016-06-10
• Study Completion: 2016-06-10
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-30
• Last Update Posted: 2022-03-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 95

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patient with Cluster headache	Neurological clinical examination	Prospective follow-up of patient with Cluster headache
Patient with Cluster headache	Psychological clinical examination	Prospective follow-up of patient with Cluster headache
Patient with Cluster headache	Blood sample	Prospective follow-up of patient with Cluster headache
Patient with Cluster headache	Questionnaires	Prospective follow-up of patient with Cluster headache
Patient with Cluster headache	Endothelial function measurement	Prospective follow-up of patient with Cluster headache

Primary Outcome Measures

Name	Time	Method
Severity of attacks	one year after inclusion
Duration of cluster headache	one year after inclusion
Duration of active periods of cluster headache	one year after inclusion
Number of active periods	one year after inclusion

Secondary Outcome Measures

Name	Time	Method
Existence of an addiction	One year after inclusion
Severity of Addiction	One year after inclusion
Reactive Hyperemic Index (RHI)	Day 0 (Inclusion visit)	Endothelial function measurement

Trial Locations

Locations (1)

CHU de Bordeaux; 🇫🇷 Bordeaux, France