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

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.

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Key information

Conditions

Refractory Chronic Cluster Headache Brain Diseases Central Nervous System Diseases Cluster Headache Headache Disorders Headache Disorders, Primary Nervous System Diseases Trigeminal Autonomic Cephalalgias

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU -Hôpital Gabriel Montpied, Clermont-Ferrand, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

18F-FDG PET

Radiation

Primary outcomes

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

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nice

Other

Registry information

Official study title

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

Acronym: MET-ONS

Important dates

Study start: 2014
Primary completion: 2015
Study completion: 2022
First posted: Mar 7, 2014
Registry last updated: Jun 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed