Refractory Chronic Cluster HeadacheMET-ONSNCT02081482
Cerebral Metabolism in Patients With Refractory Chronic Cluster Headache Treated by Occipital Nerve Stimulation
A study testing 18F-FDG PET in people with Refractory Chronic Cluster Headache, run by Centre Hospitalier Universitaire de Nice at 4 sites in France.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Refractory Chronic Cluster Headache
- What is being tested?
- 18F-FDG PET
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 4 sitesFrance
- Study dates
- 14 Mar 2014to 2 Feb 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- contraindication to MRI
- contraindication to 18F-FDG PET
- women without contraception/pregnant/breast-feeding
- patient non-compliant
- patient on legal guardianship
Trial locations and contacts
4 sites in 1 country.
France4 sites
CHU -Hôpital Gabriel Montpied
Clermont-Ferrand, 63000
Institut des Neurosciences
Marseille, 13385
Département d'Evaluation et Traitement de la Douleur - Pôle Neurosciences Cliniques - Centre Hospitalo-Universitaire de Nice
Nice, 06000
Centre d'Urgence Céphalées
Paris, 75010
About this study
Official title: Study of the Cerebral Metabolism in Patients With Refractory Chronic Cluster Headache Treated by Occipital Nerve Stimulation
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.
- Conditions
- Refractory Chronic Cluster Headache
- Being tested
- 18F-FDG PET
- Medical subject headings
- Cluster Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
18F-FDG PETRadiation
| Study group | Role | What they receive |
|---|---|---|
| subjects with refractory chronic cluster headache | Experimental | Adult subjects with refractory chronic cluster headache and ONS indication Receives: Radiation: 18F-FDG PET |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of cerebral metabolism
Changes of cerebral metabolism associated with ONS efficacy
Measured: Baseline (before ONS), 1 week after ONS , 3 month after ONS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2014 (estimated)
- Study start14 Mar 2014
- Primary completion17 Nov 2015
- Study completion2 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Refractory Chronic Cluster HeadacheStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NiceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02081482
- Sponsor's protocol ID
- 13-AOI-05
- Acronym
- MET-ONS
- Status last verified
- Jun 2026
- First submitted
- 4 Mar 2014
- Last updated
- 16 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Cerebral Metabolism in Patients With Refractory Chronic Cluster Headache Treated by Occipital Nerve Stimulation
- ClinicalTrials.gov ID
- NCT02081482
- Acronym / sponsor ID
- MET-ONS / 13-AOI-05
- Conditions
- Refractory Chronic Cluster Headache
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- 14 Mar 2014 (actual)
- Primary completion
- 17 Nov 2015 (actual)
- Study completion
- 2 Feb 2022 (actual)
- First posted
- 7 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| subjects with refractory chronic cluster headache | Experimental | Radiation: 18F-FDG PETAdult subjects with refractory chronic cluster headache and ONS indication |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- contraindication to MRI
- contraindication to 18F-FDG PET
- women without contraception/pregnant/breast-feeding
- patient non-compliant
- patient on legal guardianship
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 18F-FDG PET | Radiation | subjects with refractory chronic cluster headache |
Primary outcome
Comparison of cerebral metabolism
Time frame: Baseline (before ONS), 1 week after ONS , 3 month after ONS
Changes of cerebral metabolism associated with ONS efficacy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 18F-FDG PET in people with Refractory Chronic Cluster Headache, run by Centre Hospitalier Universitaire de Nice at 4 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of cerebral metabolism (time frame: Baseline (before ONS), 1 week after ONS , 3 month after ONS). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2026.