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

Refractory Chronic Cluster Headache Clinical Trial

— MET-ONS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02081482
• Other study ID #: 13-AOI-05
• Status: Recruiting
• Phase: N/A
• First received: March 4, 2014
• Last updated: August 13, 2015
• Start date: March 2014
• Est. completion date: August 2016

Study information

• Verified date: July 2015
• Source: Centre Hospitalier Universitaire de Nice
• Contact: Michel LANTERI-MINET, PH
• Phone: 33 (0)4-92-03-79-46
• Email: lanteri-minet.m[@]chu-nice.fr
• Is FDA regulated: No
• Health authority: France: Committee for the Protection of Personnes
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: August 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Cluster Headache
• Headache
• Refractory Chronic Cluster Headache

Intervention

Radiation:
• 18F-FDG PET

Locations

Country	Name	City	State
France	CHU -Hôpital Gabriel Montpied	Clermont Ferrand
France	Institut des Neurosciences	Marseille
France	Département d'Evaluation et Traitement de la Douleur - Pôle Neurosciences Cliniques - Centre Hospitalo-Universitaire de Nice	Nice
France	Centre d'Urgence Céphalées	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nice

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of cerebral metabolism	Changes of cerebral metabolism associated with ONS efficacy	Baseline (before ONS), 1 week after ONS , 3 month after ONS	No