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

NCT ID: NCT02081482

Last Updated: 2016-03-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-03-31

Study Completion Date

2016-08-31

Brief Summary

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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

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Conditions

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Refractory Chronic Cluster Headache

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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subjects with refractory chronic cluster headache

Adult subjects with refractory chronic cluster headache and ONS indication

Group Type EXPERIMENTAL

18F-FDG PET

Intervention Type RADIATION

Interventions

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18F-FDG PET

Intervention Type RADIATION

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire de Nice

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CHU -Hôpital Gabriel Montpied

Clermont-Ferrand, , France

Site Status

Institut des Neurosciences

Marseille, , France

Site Status

Département d'Evaluation et Traitement de la Douleur - Pôle Neurosciences Cliniques - Centre Hospitalo-Universitaire de Nice

Nice, , France

Site Status

Centre d'Urgence Céphalées

Paris, , France

Site Status

Countries

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France

Other Identifiers

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13-AOI-05

Identifier Type: -

Identifier Source: org_study_id

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