NCT00458770

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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2009

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 10, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 11, 2007

Completed
2.1 years until next milestone

Study Start

First participant enrolled

May 1, 2009

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2011

Completed
Last Updated

February 25, 2014

Status Verified

February 1, 2014

Enrollment Period

2 years

First QC Date

April 10, 2007

Last Update Submit

February 24, 2014

Conditions

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

Outcome Measures

Primary Outcomes (1)

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

    2 years

Interventions

position emission transaxial tomographyPROCEDURE

cerebral position emission transaxial tomography using 18Fluorodeoxyglucose

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • No effective contraception taken
  • unable to realize a decubitus of 15 minutes long

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pôle de Neurosciences Cliniques CHU Timone

Marseille, 13005, France

Location

MeSH Terms

Conditions

Cluster Headache

Condition Hierarchy (Ancestors)

Trigeminal Autonomic CephalalgiasHeadache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Anne DONNET, PH

    Pôle de Neurosciences Cliniques CHU Timone, 204 rue St Pierre, Marseille 13385 cedex 5 France

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 10, 2007

First Posted

April 11, 2007

Study Start

May 1, 2009

Primary Completion

May 1, 2011

Study Completion

May 1, 2011

Last Updated

February 25, 2014

Record last verified: 2014-02

Locations

FR(1)