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Study of Hypothalamic Metabolism in Spontaneous Cluster Headache Attacks

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2009 by Assistance Publique Hopitaux De Marseille.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier:
NCT00458770
First received: April 10, 2007
Last updated: June 17, 2009
Last verified: June 2009
History of Changes
  Purpose

Cluster headache is characterized by unilateral excruciating head pain and autonomic dysfunction. Hypothalamic overactivity was observed in nitrate-induced cluster-headache and in only one case of spontaneous cluster headache 'Sprenger et al, 2004). This prompted the application of hypothalamic deep brain stimulation. The aim of this data is to precise the localisation of the hypothalamic activation.


Condition Intervention
Cluster Headache
 Procedure: position emission transaxial tomography

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Study of Hypothalamic Metabolism in Spontaneous Cluster Headache Attacks

Resource links provided by NLM:

MedlinePlus related topics: Headache
U.S. FDA Resources

Further study details as provided by Assistance Publique Hopitaux De Marseille:

Primary Outcome Measures:
  • To confirm the existence of a hypothalamic promoter at the origin of Spontaneous Cluster Headache Attacks [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 10
Study Start Date: May 2009
Estimated Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: position emission transaxial tomography
    cerebral position emission transaxial tomography using 18Fluorodeoxyglucose
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • cluster headache in crisis
  • no serious illnesses in progress as cancer, autoimmune disease, liver disease
  • patient without chronic psychiatric disease excluding moderate and reactional depression
  • no demential disease
  • no anxious or depressive disease
  • no contraindication to PET scan (pregnancy and breast-feeding)
  • social security cover
  • written informed consent

Exclusion Criteria:

  • No effective contraception taken
  • unable to realize a decubitus of 15 minutes long
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00458770

Locations
France
Pôle de Neurosciences Cliniques CHU Timone
Marseille, France, 13005
Sponsors and Collaborators
Assistance Publique Hopitaux De Marseille
Investigators
Principal Investigator: Anne DONNET, PH Pôle de Neurosciences Cliniques CHU Timone, 204 rue St Pierre, Marseille 13385 cedex 5 France
  More Information

No publications provided

Responsible Party: Dr Anne DONNET, Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier: NCT00458770     History of Changes
Other Study ID Numbers: 2006/22, 2009-A00149-48
Study First Received: April 10, 2007
Last Updated: June 17, 2009
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Assistance Publique Hopitaux De Marseille:
Comparison of a spontaneous acute cluster headache attack and rest (no pain) in ten patients with cluster headache defined with IHS criteria

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

ClinicalTrials.gov processed this record on June 18, 2013