Study of Hypothalamic Metabolism in Spontaneous Cluster Headache Attacks

February 24, 2014 updated by: Assistance Publique Hopitaux De Marseille
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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Marseille, France, 13005
        • Pôle de Neurosciences Cliniques CHU Timone

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To confirm the existence of a hypothalamic promoter at the origin of Spontaneous Cluster Headache Attacks
Time Frame: 2 years
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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 record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2009

Primary Completion (Actual)

May 1, 2011

Study Completion (Actual)

May 1, 2011

Study Registration Dates

First Submitted

April 10, 2007

First Submitted That Met QC Criteria

April 10, 2007

First Posted (Estimate)

April 11, 2007

Study Record Updates

Last Update Posted (Estimate)

February 25, 2014

Last Update Submitted That Met QC Criteria

February 24, 2014

Last Verified

February 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2006/22
  • 2009-A00149-48

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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