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Cerebral Metabolism in Patients With Refractory Chronic Cluster Headache Treated by Occipital Nerve Stimulation (MET-ONS)

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ClinicalTrials.gov Identifier: NCT02081482
Recruitment Status : Unknown
Verified March 2016 by Centre Hospitalier Universitaire de Nice.
Recruitment status was:  Active, not recruiting
First Posted : March 7, 2014
Last Update Posted : March 21, 2016
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nice

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.


Condition or disease Intervention/treatment Phase
Refractory Chronic Cluster Headache Radiation: 18F-FDG PET Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Study of the Cerebral Metabolism in Patients With Refractory Chronic Cluster Headache Treated by Occipital Nerve Stimulation
Study Start Date : March 2014
Actual Primary Completion Date : July 2015
Estimated Study Completion Date : August 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Headache

Arm Intervention/treatment
Experimental: subjects with refractory chronic cluster headache
Adult subjects with refractory chronic cluster headache and ONS indication
Radiation: 18F-FDG PET



Primary Outcome Measures :
  1. Comparison of cerebral metabolism [ Time Frame: Baseline (before ONS), 1 week after ONS , 3 month after ONS ]
    Changes of cerebral metabolism associated with ONS efficacy



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02081482


Locations
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France
CHU -Hôpital Gabriel Montpied
Clermont Ferrand, France, 63000
Institut des Neurosciences
Marseille, France, 13385
Département d'Evaluation et Traitement de la Douleur - Pôle Neurosciences Cliniques - Centre Hospitalo-Universitaire de Nice
Nice, France, 06000
Centre d'Urgence Céphalées
Paris, France, 75010
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nice
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Responsible Party: Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov Identifier: NCT02081482    
Other Study ID Numbers: 13-AOI-05
First Posted: March 7, 2014    Key Record Dates
Last Update Posted: March 21, 2016
Last Verified: March 2016
Additional relevant MeSH terms:
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Cluster Headache
Headache
Pain
Neurologic Manifestations
Trigeminal Autonomic Cephalalgias
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Fluorodeoxyglucose F18
Radiopharmaceuticals
Molecular Mechanisms of Pharmacological Action