Study of Hypothalamic Metabolism in Spontaneous Cluster H... | NCT00458770

Studies
Study of Hypothalamic Metabolism in Spontaneous Cluster Headache Attacks

NCT00458770

Sponsor

Assistance Publique Hopitaux De Marseille

Status

Terminated

Last Update Posted

Feb 25, 2014Estimated

Enrollment

1Actual

Phase

Not Applicable

Conditions

Cluster Headache

Interventions

position emission transaxial tomography

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2009-A00149-48

Status Module

Record Verification Date

Feb 2014

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2009

Primary Completion Date

May 2011Actual

Completion Date

May 2011Actual

First Submitted Date

Apr 10, 2007

First Submission Date that Met QC Criteria

Apr 10, 2007

First Posted Date

Apr 11, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 24, 2014

Last Update Posted Date

Feb 25, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

1Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
position emission transaxial tomography	Procedure	cerebral position emission transaxial tomography using 18Fluorodeoxyglucose

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Anne DONNET, PH	Pôle de Neurosciences Cliniques CHU Timone, 204 rue St Pierre, Marseille 13385 cedex 5 France	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Pôle de Neurosciences Cliniques CHU Timone		Marseille		13005	France

Condition Browse Module

MeSH Terms

ID	Term
D003027	Cluster Headache

Ancestor Terms

ID	Term
D051303	Trigeminal Autonomic Cephalalgias
D051270	Headache Disorders, Primary
D020773	Headache Disorders
D001927	Brain Diseases

Browse Leaves

Not provided

Browse Branches

Not provided