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Cluster Headache, Addictions and Vascular Function (CHAD)

This study is currently recruiting participants.
Verified December 2015 by University Hospital, Bordeaux
Sponsor:
ClinicalTrials.gov Identifier:
NCT02640105
First Posted: December 28, 2015
Last Update Posted: December 28, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
University Hospital, Bordeaux
  Purpose
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 Intervention
Cluster Headache Other: Neurological clinical examination Other: Psychological clinical examination Other: Questionnaires Other: Blood sample Other: Endothelial function measurement

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 12 Months
Official Title: Cluster Headache (CH), Addictions and Vascular Function

Resource links provided by NLM:


Further study details as provided by University Hospital, Bordeaux:

Primary Outcome Measures:
  • Duration of active periods of cluster headache [ Time Frame: Day 0 (Inclusion visit) ]
  • Number of active periods [ Time Frame: Day 0 (Inclusion visit) ]
  • Duration of cluster headache [ Time Frame: Day 0 (Inclusion visit) ]
  • Severity of attacks [ Time Frame: Day 0 (Inclusion visit) ]
  • Duration of active periods of cluster headache [ Time Frame: one year after inclusion ]
  • Number of active periods [ Time Frame: one year after inclusion ]
  • Duration of cluster headache [ Time Frame: one year after inclusion ]
  • Severity of attacks [ Time Frame: one year after inclusion ]

Secondary Outcome Measures:
  • Existence of an addiction [ Time Frame: Day 0 (Inclusion visit) ]
  • Existence of an addiction [ Time Frame: One year after inclusion ]
  • Severity of Addiction [ Time Frame: Day 0 (Inclusion visit) ]
  • Severity of Addiction [ Time Frame: One year after inclusion ]
  • Reactive Hyperemic Index (RHI) [ Time Frame: Day 0 (Inclusion visit) ]
    Endothelial function measurement


Estimated Enrollment: 150
Study Start Date: June 2014
Estimated Study Completion Date: June 2017
Estimated Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patient with cluster headache
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02640105


Contacts
Contact: Virginie DOUSSET 0556798711 virginie.dousset@chu-bordeaux.fr

Locations
France
CHU de Bordeaux Recruiting
Bordeaux, France, 33076
Contact: Virginie DOUSSET    0556798711    virginie.dousset@chu-bordeaux.fr   
Sponsors and Collaborators
University Hospital, Bordeaux
  More Information

Responsible Party: University Hospital, Bordeaux
ClinicalTrials.gov Identifier: NCT02640105     History of Changes
Other Study ID Numbers: CHUBX 2013/14
First Submitted: November 23, 2015
First Posted: December 28, 2015
Last Update Posted: December 28, 2015
Last Verified: December 2015

Additional relevant MeSH terms:
Headache
Cluster Headache
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Trigeminal Autonomic Cephalalgias
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases