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

Centre Hospitalier Universitaire de Nice

Status: Unknown

Conditions: Refractory Chronic Cluster Headache

Treatments: Radiation: 18F-FDG PET

Study type: Interventional

Funder types: Other

Identifiers

NCT02081482

13-AOI-05

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Health Services Research

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

subjects with refractory chronic cluster headache

Experimental group

Description:

Adult subjects with refractory chronic cluster headache and ONS indication

Treatment:

Radiation: 18F-FDG PET