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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
Centre Hospitalier Universitaire de Nice
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Refractory Chronic Cluster Headache

Eligibility Criteria

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

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

First Posted
March 4, 2014
Last Updated
March 18, 2016
Sponsor
Centre Hospitalier Universitaire de Nice
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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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