NCT00458770TerminatedNot Applicable
Study of Hypothalamic Metabolism in Spontaneous Cluster Headache Attacks
Assistance Publique Hopitaux De Marseille1 site in 1 country1 target enrollmentStarted: May 1, 2009Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Enrollment
- 1
- Locations
- 1
- Primary Endpoint
- To confirm the existence of a hypothalamic promoter at the origin of Spontaneous Cluster Headache Attacks
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Basic Science
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- 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
Outcomes
Primary Outcomes
To confirm the existence of a hypothalamic promoter at the origin of Spontaneous Cluster Headache Attacks
Time Frame: 2 years
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
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