Cluster Headache, Addictions and Vascular Function

Cluster Headache Clinical Trial

— CHAD  

Official title:

Cluster Headache (CH), Addictions and Vascular Function

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02640105
• Other study ID #: CHUBX 2013/14
• Status: Completed
• Start date: June 25, 2014
• Est. completion date: June 10, 2016

Study information

• Verified date: March 2022
• Source: University Hospital, Bordeaux
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 95
• Est. completion date: June 10, 2016
• Est. primary completion date: June 10, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cluster Headache
• Headache

Intervention

Other:
• Neurological clinical examination
Diagnostic and description of cluster headache
• Psychological clinical examination
Scale and questionnaires
• Questionnaires
Psychopathological and cognitive questionnaires
• Blood sample
Blood sample for DNA collection
• Endothelial function measurement
Endothelial function will be measured with a noninvasive Peripheral Arterial Tone (PAT) signal technology using the EndoPAT device

Locations

Country	Name	City	State
France	CHU de Bordeaux	Bordeaux

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Bordeaux

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Duration of active periods of cluster headache		Day 0 (Inclusion visit)
Primary	Number of active periods		Day 0 (Inclusion visit)
Primary	Duration of cluster headache		Day 0 (Inclusion visit)
Primary	Severity of attacks		Day 0 (Inclusion visit)
Primary	Duration of active periods of cluster headache		one year after inclusion
Primary	Number of active periods		one year after inclusion
Primary	Duration of cluster headache		one year after inclusion
Primary	Severity of attacks		one year after inclusion
Secondary	Existence of an addiction		Day 0 (Inclusion visit)
Secondary	Existence of an addiction		One year after inclusion
Secondary	Severity of Addiction		Day 0 (Inclusion visit)
Secondary	Severity of Addiction		One year after inclusion
Secondary	Reactive Hyperemic Index (RHI)	Endothelial function measurement	Day 0 (Inclusion visit)