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Study of Hypothalamic Metabolism in Spontaneous Cluster Headache Attacks

Primary Purpose

Cluster Headache

Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
position emission transaxial tomography
Sponsored by
Assistance Publique Hopitaux De Marseille
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional basic science trial for Cluster Headache focused on measuring Comparison of a spontaneous acute cluster headache attack and rest (no pain) in ten patients with cluster headache defined with IHS criteria

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Pôle de Neurosciences Cliniques CHU Timone

Outcomes

Primary Outcome Measures

To confirm the existence of a hypothalamic promoter at the origin of Spontaneous Cluster Headache Attacks

Secondary Outcome Measures

Full Information

First Posted
April 10, 2007
Last Updated
February 24, 2014
Sponsor
Assistance Publique Hopitaux De Marseille
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1. Study Identification

Unique Protocol Identification Number
NCT00458770
Brief Title
Study of Hypothalamic Metabolism in Spontaneous Cluster Headache Attacks
Official Title
Study of Hypothalamic Metabolism in Spontaneous Cluster Headache Attacks
Study Type
Interventional

2. Study Status

Record Verification Date
February 2014
Overall Recruitment Status
Terminated
Study Start Date
May 2009 (undefined)
Primary Completion Date
May 2011 (Actual)
Study Completion Date
May 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique Hopitaux De Marseille

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cluster Headache
Keywords
Comparison of a spontaneous acute cluster headache attack and rest (no pain) in ten patients with cluster headache defined with IHS criteria

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
position emission transaxial tomography
Intervention Description
cerebral position emission transaxial tomography using 18Fluorodeoxyglucose
Primary Outcome Measure Information:
Title
To confirm the existence of a hypothalamic promoter at the origin of Spontaneous Cluster Headache Attacks
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anne DONNET, PH
Organizational Affiliation
Pôle de Neurosciences Cliniques CHU Timone, 204 rue St Pierre, Marseille 13385 cedex 5 France
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pôle de Neurosciences Cliniques CHU Timone
City
Marseille
ZIP/Postal Code
13005
Country
France

12. IPD Sharing Statement

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Study of Hypothalamic Metabolism in Spontaneous Cluster Headache Attacks

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