Cerebral Metabolism in Patients With Refractory Chronic C... | NCT02081482

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

NCT02081482

Sponsor

Centre Hospitalier Universitaire de Nice

Status

Completed

Last Update Posted

Jun 16, 2026Actual

Enrollment

20Actual

Phase

Not Applicable

Conditions

Refractory Chronic Cluster Headache

Interventions

18F-FDG PET

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2026

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 14, 2014Actual

Primary Completion Date

Nov 17, 2015Actual

Completion Date

Feb 2, 2022Actual

First Submitted Date

Mar 4, 2014

First Submission Date that Met QC Criteria

Mar 5, 2014

First Posted Date

Mar 7, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 15, 2026

Last Update Posted Date

Jun 16, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
subjects with refractory chronic cluster headache	Experimental	Adult subjects with refractory chronic cluster headache and ONS indication	Radiation: 18F-FDG PET

Interventions

Name	Type	Description	Arm Group Labels	Other Names
18F-FDG PET	Radiation		subjects with refractory chronic cluster headache

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Comparison of cerebral metabolism	Changes of cerebral metabolism associated with ONS efficacy	Baseline (before ONS), 1 week after ONS , 3 month after ONS

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CHU -Hôpital Gabriel Montpied		Clermont-Ferrand		63000	France
Institut des Neurosciences

Condition Browse Module

MeSH Terms

ID	Term
D003027	Cluster Headache

Ancestor Terms

ID	Term
D051303	Trigeminal Autonomic Cephalalgias
D051270	Headache Disorders, Primary
D020773	Headache Disorders
D001927	Brain Diseases

Browse Leaves

Not provided

Browse Branches

Not provided