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Refractory Chronic Headache DisordersNGONCT01842763

French Database of Occipital Nerves Stimulation in the Treatment of Refractory Chronic Headache Disorders

An observational study of Refractory Chronic Headache Disorders, run by Centre Hospitalier Universitaire de Nice at 16 sites in France.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

The purpose of this non interventional research is to set up a French database, initially for 3 years, of patients suffering from refractory chronic headache disorders (chronic migraine, cluster headache, chronic paroxysmal hemicranias, SUNCT syndrome, hemicrania continua, cervicogenic headache disorders), and treated… Read more about this study

Who is it for?
Any age
Conditions the study is for
Refractory Chronic Headache Disorders
How many people
246 participants
Where
16 sitesFrance
Study dates
Mar 2013to Sep 2027
Phase
Observational
Are there results?
Not yet: the study is under way

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 Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: Patients suffering from refractory chronic headache disorders (chronic migraine, cluster headache, chronic paroxysmal hemicranias, SUNCT syndrome (Short-lasting Unilateral Neuralgiform headache attacks with Conjunctival injection and Tearing), hemicrania continua, cervicogenic headache disorders) according to ICHD-II

Who may be able to join

  • patients suffering from refractory chronic headache disorders and treated by occipital nerves stimulation

Who cannot join

  • patients who don't agree with participating in the study because the ending of professional confidentiality is required for setting up the database

Trial locations and contacts

16 sites in 1 country.

16 sites in 1 country

France16 sites

  • Clermont Ferrand CHU

    Clermont-Ferrand, 63003

  • Hopitaux Civil de Colmar

    Colmar, Haut-rhin, 68024

  • Annecy Genevois CHU

    Épagny, 74370

  • Grenoble CHU

    Grenoble, 38043

  • Lille CHU

    Lille, 59037

  • Limoges CHU

    Limoges, 87000

  • HCL

    Lyon, 69229

  • APHM

    Marseille, 13354

  • Nancy CHU

    Nancy, 54035

  • Nantes CHU

    Nantes, 44093

  • Département d'Evaluation et Traitement de la Douleur

    Nice, 06000

  • AP-HP Lariboisière

    Paris, 75184

  • Adolphe de Rothschild Foundation

    Paris, 75940

  • Poitiers CHU

    Poitiers, 86021

  • Saint Etienne CHU

    Saint-Etienne, 42055

  • Foch Hospital

    Suresnes, 92150

Other trials in France

About this study

The purpose of this non interventional research is to set up a French database, initially for 3 years, of patients suffering from refractory chronic headache disorders (chronic migraine, cluster headache, chronic paroxysmal hemicranias, SUNCT syndrome, hemicrania continua, cervicogenic headache disorders), and treated by occipital nerves stimulation.

Every team using this neuromodulation approach in France is likely to participate in the network.

Read more

Fifty patients a year are expected. They will be informed about data which are collected and why they are collected.

The data will come from medical files and questionnaires filling out by the patients. The data will be collected on a case report form adapted to each refractory chronic headache disorder. The case report form pages will be faxed to the coordinating team who will enter the data in the database and analyse the data in a descriptive manner.

These data are social and demographic data, medical data (headache features, headache functional and emotional impact, medications, and concomitant medical conditions), technical data (kind of electrodes and implantable pulse generator used, stimulation parameters chosen), and safety data.

This research should provide an update on practices, an evaluation of the efficacy and long term safety of occipital nerves stimulation, and perhaps help in identifying response predictive factors to this neuromodulation approach.

Keywords
Chronic daily headache, treated by occipital nerves stimulation, peripheral neuromodulation, occipital nerves, network, database
Medical subject headings
Headache Disorders

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. observation of a disease or medical condition under normal conditions

    social and demographic data, medical data (headache features, headache functional and emotional impact, medications, and concomitant medical conditions), technical data (kind of electrodes and implantable pulse generator used, stimulation parameters chosen), and safety data.

    Measured: at each visit (up to 4 years)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Apr 2013 (estimated)
  2. Study startMar 2013
  3. Primary completionSep 2027 (estimated)
  4. Study completionSep 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Cross-sectional
Enrolment
246 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01842763
Sponsor's protocol ID
12-PP-08
Acronym
NGO
Status last verified
Mar 2025
First submitted
22 Mar 2013
Last updated
18 Mar 2025
Results posted
No
Data monitoring committee
No

Publications

  • Fontaine D, Fabre R, Leplus A, Donnet A, Regis J, Balossier A, Lucas C, Buisset N, Raoul S, Derrey S, Jarraya B, Creach C, Chabardes S, Voirin J, Colnat-Coulbois S, Caire F, Rigoard P, Demarquay G, Simon E, Lanteri-Minet M. Predictive factors of effectiveness of occipital nerve stimulation for chronic cluster headache: data from for the French ONS registry. J Headache Pain. 2026 Mar 13;27(1):114. doi: 10.1186/s10194-026-02319-w.

    PubMed 41826825

  • Messaoudi S, Leplus A, Donnet A, Regis J, Balossier A, Raoul S, Demarquay G, Simon E, Moisset X, Sinardet D, Voirin J, Colnat-Coulbois S, Lanteri-Minet M, Fontaine D. Decreasing the Risk of Lead Migration in Occipital Nerve Stimulation for Cluster Headache Using Dedicated Leads. Neuromodulation. 2026 Feb 25:S1094-7159(26)00015-2. doi: 10.1016/j.neurom.2026.01.009. Online ahead of print.

    PubMed 41739034

  • Balossier A, Donnet A, Regis J, Leplus A, Lanteri-Minet M, Fontaine D. Occipital Nerve Stimulation for Recurrent Trigeminal Neuralgia Without Occipital Pain. Neuromodulation. 2023 Dec;26(8):1795-1801. doi: 10.1016/j.neurom.2022.03.012. Epub 2022 Jun 7.

    PubMed 35688701

  • Fontaine D, Blond S, Lucas C, Regis J, Donnet A, Derrey S, Guegan-Massardier E, Jarraya B, Dang-Vu B, Bourdain F, Valade D, Roos C, Creach C, Chabardes S, Giraud P, Voirin J, Bloch J, Rocca A, Colnat-Coulbois S, Caire F, Roger C, Romettino S, Lanteri-Minet M. Occipital nerve stimulation improves the quality of life in medically-intractable chronic cluster headache: Results of an observational prospective study. Cephalalgia. 2017 Oct;37(12):1173-1179. doi: 10.1177/0333102416673206. Epub 2016 Oct 3.

    PubMed 27697849

Questions about this trial

What is this clinical trial studying?

An observational study of Refractory Chronic Headache Disorders, run by Centre Hospitalier Universitaire de Nice at 16 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 1 inclusion and 1 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: under way, not looking for participants, as of the sponsor's last update on 18 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 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?

This study is still under way. Results are not available in the source record yet.

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?

observation of a disease or medical condition under normal conditions (time frame: at each visit (up to 4 years)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01842763, which also lists 4 linked publications.

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 18 Mar 2025.

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