CHAD: Cluster Headache, Addictions and Vascular Function

Sponsor

University Hospital, Bordeaux (Other)

Overall Status

Completed

CT.gov ID

NCT02640105

Collaborator

(none)

Enrollment

Location

23.5

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cluster Headache	Other: Neurological clinical examination Other: Psychological clinical examination Other: Questionnaires Other: Blood sample Other: Endothelial function measurement

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 Design

Study Type:

Observational [Patient Registry]

Actual Enrollment :

95 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Cluster Headache (CH), Addictions and Vascular Function

Actual Study Start Date :

Jun 25, 2014

Actual Primary Completion Date :

Jun 10, 2016

Actual Study Completion Date :

Jun 10, 2016

Arms and Interventions

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

Arm

Intervention/Treatment

Patient with Cluster headache

Prospective follow-up of patient with Cluster headache

Other: Neurological clinical examination

Diagnostic and description of cluster headache

Other: Psychological clinical examination

Scale and questionnaires

Other: Questionnaires

Psychopathological and cognitive questionnaires

Other: Blood sample

Blood sample for DNA collection

Other: Endothelial function measurement

Endothelial function will be measured with a noninvasive Peripheral Arterial Tone (PAT) signal technology using the EndoPAT device

Outcome Measures

Primary Outcome Measures

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

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) [Day 0 (Inclusion visit)]
Endothelial function measurement

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHU de Bordeaux	Bordeaux		France	33076

Sponsors and Collaborators

University Hospital, Bordeaux

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University Hospital, Bordeaux

ClinicalTrials.gov Identifier:

NCT02640105

Other Study ID Numbers:

CHUBX 2013/14

First Posted:

Dec 28, 2015

Last Update Posted:

Mar 31, 2022

Last Verified:

Mar 1, 2022

Additional relevant MeSH terms:

Cluster Headache

Headache

Study Results

No Results Posted as of Mar 31, 2022