ClinicalTrials.gg
CompletedNCT02081482MET-ONSUpdated Jun 16, 2026

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

An interventional study of 18F-FDG PET in Refractory Chronic Cluster Headache, sponsored by Centre Hospitalier Universitaire de Nice. Completed at 4 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-16.

Sponsored by Centre Hospitalier Universitaire de Nice · Not applicable, Interventional, and Health services research

Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

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Conditions studied

  • Refractory Chronic Cluster Headache

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03

In context

Cluster Headache

123 studies on the registry are indexed under Cluster Headache; 26 are open to participants now.

This study's enrollment of 20 is below the median of 42 across 90 interventional studies indexed under Cluster Headache.

Browse Cluster Headache studies →

Lead sponsor

Centre Hospitalier Universitaire de Nice is the lead sponsor of 723 studies on the registry; 176 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • age > 18 years
  • chronic cluster headache (according to the IHS)
  • in who a treatment by ONS have been indicated
  • patient affiliated at social security,
  • signed

Exclusion criteria

Exclusion Criteria:

  • to MRI
  • contraindication to 18F-FDG PET
  • women without /pregnant/breast-feeding
  • patient non-compliant
  • patient on legal guardianship
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Relapsed and refractory

Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (actual)

Study arms

  • Experimental
    subjects with refractory chronic cluster headache

    Adult subjects with refractory chronic cluster headache and ONS indication

    Radiation: 18F-FDG PET

Interventions

  • Radiation18F-FDG PET
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What researchers measure

Primary outcomes

  1. Comparison of cerebral metabolism

    Changes of cerebral metabolism associated with ONS efficacy

    Time frame: Baseline (before ONS), 1 week after ONS , 3 month after ONS

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Study locations

4 sites
  • CHU -Hôpital Gabriel Montpied
    Clermont-Ferrand, 63000, France
  • Institut des Neurosciences
    Marseille, 13385, France
  • Département d'Evaluation et Traitement de la Douleur - Pôle Neurosciences Cliniques - Centre Hospitalo-Universitaire de Nice
    Nice, 06000, France
  • Centre d'Urgence Céphalées
    Paris, 75010, France
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 16, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02081482
Responsible party
Sponsor
First posted
Mar 7, 2014
Start date
Mar 14, 2014
Primary completion
Nov 17, 2015
Completion
Feb 2, 2022
Last update
Jun 16, 2026

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.

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