Cluster Headache, Addictions and Vascular Function (CHAD)

March 30, 2022 updated by: University Hospital, Bordeaux

Cluster Headache (CH), Addictions and Vascular Function

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

95

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Bordeaux, France, 33076
        • CHU de Bordeaux

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patient with cluster headache

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Bordeaux

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 25, 2014

Primary Completion (Actual)

June 10, 2016

Study Completion (Actual)

June 10, 2016

Study Registration Dates

First Submitted

November 23, 2015

First Submitted That Met QC Criteria

December 21, 2015

First Posted (Estimate)

December 28, 2015

Study Record Updates

Last Update Posted (Actual)

March 31, 2022

Last Update Submitted That Met QC Criteria

March 30, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHUBX 2013/14

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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