Study of Hypothalamic Metabolism in Spontaneous Cluster Headache Attacks

• Sponsor: Assistance Publique Hopitaux De Marseille (Other)
• Overall Status: Terminated
• CT.gov ID: NCT00458770
• Collaborator: (none)
• Enrollment: 1
• Location: 1
• Duration (Months): 24
• Patients Per Site Per Month: 0

Study Details

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	Phase
Cluster Headache	Procedure: position emission transaxial tomography	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 1 participants
• Allocation: N/A
• 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 1, 2009
• Actual Primary Completion Date: May 1, 2011
• Actual Study Completion Date: May 1, 2011

Outcome Measures

Primary Outcome Measures

1. To confirm the existence of a hypothalamic promoter at the origin of Spontaneous Cluster Headache Attacks [2 years]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Assistance Publique Hopitaux De Marseille
• ClinicalTrials.gov Identifier: NCT00458770
• Other Study ID Numbers: 2006/22; 2009-A00149-48
• First Posted: Apr 11, 2007
• Last Update Posted: Feb 25, 2014
• Last Verified: Feb 1, 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: Cluster Headache; Headache

Study Results

No Results Posted as of Feb 25, 2014