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NCT Number: NCT02640105

Cluster Headache, 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.

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Key information

Conditions

Cluster Headache Brain Diseases Central Nervous System Diseases Headache Disorders Headache Disorders, Primary Nervous System Diseases Trigeminal Autonomic Cephalalgias

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU de Bordeaux

Bordeaux, 33076, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Neurological clinical examination

Other

Diagnostic and description of cluster headache

Psychological clinical examination

Other

Scale and questionnaires

questionnaires

Other

Psychopathological and cognitive questionnaires

blood sample

Other

Blood sample for DNA collection

Endothelial function measurement

Other

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

Primary outcomes

  1. Duration of active periods of cluster headache

    Time frame: Day 0 (Inclusion visit)

  2. Number of active periods

    Time frame: Day 0 (Inclusion visit)

  3. Duration of cluster headache

    Time frame: Day 0 (Inclusion visit)

  4. Severity of attacks

    Time frame: Day 0 (Inclusion visit)

  5. Duration of active periods of cluster headache

    Time frame: one year after inclusion

  6. Number of active periods

    Time frame: one year after inclusion

  7. Duration of cluster headache

    Time frame: one year after inclusion

  8. Severity of attacks

    Time frame: one year after inclusion

Secondary outcomes

  1. Existence of an addiction

    Time frame: Day 0 (Inclusion visit)

  2. Existence of an addiction

    Time frame: One year after inclusion

  3. Severity of Addiction

    Time frame: Day 0 (Inclusion visit)

  4. Severity of Addiction

    Time frame: One year after inclusion

  5. Reactive Hyperemic Index (RHI)

    Time frame: Day 0 (Inclusion visit)

    Endothelial function measurement

Sponsors and collaborators

Lead sponsor

University Hospital, Bordeaux

Other

Registry information

Official study title

Cluster Headache (CH), Addictions and Vascular Function

Acronym: CHAD

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Dec 28, 2015
Registry last updated
Mar 31, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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