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Study of Hypothalamic Metabolism in Spontaneous Cluster Headache Attacks

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. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00458770
Recruitment Status : Terminated
First Posted : April 11, 2007
Last Update Posted : February 25, 2014
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment
Cluster Headache Procedure: position emission transaxial tomography

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Study of Hypothalamic Metabolism in Spontaneous Cluster Headache Attacks
Study Start Date : May 2009
Primary Completion Date : May 2011
Study Completion Date : May 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Headache
U.S. FDA Resources

Arms and Interventions

Intervention Details:
    Procedure: position emission transaxial tomography
    cerebral position emission transaxial tomography using 18Fluorodeoxyglucose

Outcome Measures

Primary Outcome Measures :
  1. To confirm the existence of a hypothalamic promoter at the origin of Spontaneous Cluster Headache Attacks [ Time Frame: 2 years ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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

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): 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

Responsible Party: Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier: NCT00458770     History of Changes
Other Study ID Numbers: 2006/22
2009-A00149-48
First Posted: April 11, 2007    Key Record Dates
Last Update Posted: February 25, 2014
Last Verified: February 2014

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:
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