Cerebral Metabolism in Patients With Refractory Chronic Cluster Headache Treated by Occipital Nerve Stimulation

Not Applicable

• Conditions: Refractory Chronic Cluster Headache
• Interventions: Radiation: 18F-FDG PET

• Registration Number: NCT02081482
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-03
• Study First Submitted: 2014-03-04
• Study First Submitted QC: 2014-03-05
• Study First Posted: 2014-03-07
• Primary Completion: 2015-07
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-18
• Last Update Posted: 2016-03-21
• Study Completion: 2016-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
subjects with refractory chronic cluster headache	18F-FDG PET	Adult subjects with refractory chronic cluster headache and ONS indication

Primary Outcome Measures

Name	Time	Method
Comparison of cerebral metabolism	Baseline (before ONS), 1 week after ONS , 3 month after ONS	Changes of cerebral metabolism associated with ONS efficacy

Trial Locations

Locations (4)

CHU -Hôpital Gabriel Montpied; 🇫🇷 Clermont Ferrand, France

Centre d'Urgence Céphalées; 🇫🇷 Paris, France

Département d'Evaluation et Traitement de la Douleur - Pôle Neurosciences Cliniques - Centre Hospitalo-Universitaire de Nice; 🇫🇷 Nice, France

Institut des Neurosciences; 🇫🇷 Marseille, France