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

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02081482
Acronym
MET-ONS
Enrollment
20
Registered
2014-03-07
Start date
2014-03-14
Completion date
2022-02-02
Last updated
2026-06-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Refractory Chronic Cluster Headache

Brief 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.

Interventions

RADIATION18F-FDG PET

Sponsors

Centre Hospitalier Universitaire de Nice
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Comparison of cerebral metabolismBaseline (before ONS), 1 week after ONS , 3 month after ONSChanges of cerebral metabolism associated with ONS efficacy

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 17, 2026