Overview

This trial is active, not recruiting.

Condition refractory chronic cluster headache
Treatment 18f-fdg pet
Sponsor Centre Hospitalier Universitaire de Nice
Start date March 2014
End date July 2015
Trial size 20 participants
Trial identifier NCT02081482, 13-AOI-05

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Primary purpose health services research
Arm
(Experimental)
Adult subjects with refractory chronic cluster headache and ONS indication
18f-fdg pet

Primary Outcomes

Measure
Comparison of cerebral metabolism
time frame: Baseline (before ONS), 1 week after ONS , 3 month after ONS

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Study of the Cerebral Metabolism in Patients With Refractory Chronic Cluster Headache Treated by Occipital Nerve Stimulation
Trial information was received from ClinicalTrials.gov and was last updated in March 2016.
Information provided to ClinicalTrials.gov by Centre Hospitalier Universitaire de Nice.