Study of Hypothalamic Metabolism in Spontaneous Cluster Headache Attacks

Cluster Headache Clinical Trial

Official title:

Study of Hypothalamic Metabolism in Spontaneous Cluster Headache Attacks

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00458770
• Other study ID #: 2006/22
• Secondary ID: 2009-A00149-48
• Status: Terminated
• Phase: N/A
• First received: April 10, 2007
• Last updated: February 24, 2014
• Start date: May 2009
• Est. completion date: May 2011

Study information

• Verified date: February 2014
• Source: Assistance Publique Hopitaux De Marseille
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: May 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Cluster Headache
• Headache

Intervention

Procedure:
• position emission transaxial tomography
cerebral position emission transaxial tomography using 18Fluorodeoxyglucose

Locations

Country	Name	City	State
France	Pôle de Neurosciences Cliniques CHU Timone	Marseille

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique Hopitaux De Marseille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To confirm the existence of a hypothalamic promoter at the origin of Spontaneous Cluster Headache Attacks		2 years	No