Cerebral Metabolism in Patients With Refractory Chronic Cluster Headache Treated by Occipital Nerve Stimulation (MET-ONS)
Primary Purpose
Refractory Chronic Cluster Headache
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
18F-FDG PET
Sponsored by
About this trial
This is an interventional health services research trial for Refractory Chronic Cluster Headache
Eligibility Criteria
Inclusion Criteria:
- age > 18 years
- chronic cluster headache (according to the IHS)
- refractory in who a treatment by ONS have been indicated
- patient affiliated at social security,
- informed consent signed
Exclusion Criteria:
- contraindication to MRI
- contraindication to 18F-FDG PET
- women without contraception/pregnant/breast-feeding
- patient non-compliant
- patient on legal guardianship
Sites / Locations
- CHU -Hôpital Gabriel Montpied
- Institut des Neurosciences
- Département d'Evaluation et Traitement de la Douleur - Pôle Neurosciences Cliniques - Centre Hospitalo-Universitaire de Nice
- Centre d'Urgence Céphalées
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
subjects with refractory chronic cluster headache
Arm Description
Adult subjects with refractory chronic cluster headache and ONS indication
Outcomes
Primary Outcome Measures
Comparison of cerebral metabolism
Changes of cerebral metabolism associated with ONS efficacy
Secondary Outcome Measures
Full Information
NCT ID
NCT02081482
First Posted
March 4, 2014
Last Updated
March 18, 2016
Sponsor
Centre Hospitalier Universitaire de Nice
1. Study Identification
Unique Protocol Identification Number
NCT02081482
Brief Title
Cerebral Metabolism in Patients With Refractory Chronic Cluster Headache Treated by Occipital Nerve Stimulation
Acronym
MET-ONS
Official Title
Study of the Cerebral Metabolism in Patients With Refractory Chronic Cluster Headache Treated by Occipital Nerve Stimulation
Study Type
Interventional
2. Study Status
Record Verification Date
March 2016
Overall Recruitment Status
Unknown status
Study Start Date
March 2014 (undefined)
Primary Completion Date
July 2015 (Actual)
Study Completion Date
August 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Nice
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The occipital nerve stimulation (ONS) is used to treat patients with refractory primary chronic headache but its mechanism of action (MoA) remains unknown. Different hypothesis have been suggested in particular a specific action on cerebral generators involved in different types of primary headaches or a non specific action on pain modulatory network.
The aim of this study, using the chronic cluster headache as a model, is to determine the changes in cerebral metabolism induced by ONS to precise its MoA in the treatment of primary chronic headache.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Refractory Chronic Cluster Headache
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
subjects with refractory chronic cluster headache
Arm Type
Experimental
Arm Description
Adult subjects with refractory chronic cluster headache and ONS indication
Intervention Type
Radiation
Intervention Name(s)
18F-FDG PET
Primary Outcome Measure Information:
Title
Comparison of cerebral metabolism
Description
Changes of cerebral metabolism associated with ONS efficacy
Time Frame
Baseline (before ONS), 1 week after ONS , 3 month after ONS
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
age > 18 years
chronic cluster headache (according to the IHS)
refractory in who a treatment by ONS have been indicated
patient affiliated at social security,
informed consent signed
Exclusion Criteria:
contraindication to MRI
contraindication to 18F-FDG PET
women without contraception/pregnant/breast-feeding
patient non-compliant
patient on legal guardianship
Facility Information:
Facility Name
CHU -Hôpital Gabriel Montpied
City
Clermont Ferrand
ZIP/Postal Code
63000
Country
France
Facility Name
Institut des Neurosciences
City
Marseille
ZIP/Postal Code
13385
Country
France
Facility Name
Département d'Evaluation et Traitement de la Douleur - Pôle Neurosciences Cliniques - Centre Hospitalo-Universitaire de Nice
City
Nice
ZIP/Postal Code
06000
Country
France
Facility Name
Centre d'Urgence Céphalées
City
Paris
ZIP/Postal Code
75010
Country
France
12. IPD Sharing Statement
Learn more about this trial
Cerebral Metabolism in Patients With Refractory Chronic Cluster Headache Treated by Occipital Nerve Stimulation
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