French Database of Occipital Nerves Stimulation in the Treatment of Refractory Chronic Headache Disorders
NCT ID: NCT01842763
Last Updated: 2025-03-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
246 participants
OBSERVATIONAL
2013-03-31
2027-09-30
Brief Summary
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Every team using this neuromodulation approach in France is likely to participate in the network.
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.
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Detailed Description
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Conditions
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Study Design
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OTHER
CROSS_SECTIONAL
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
ALL
No
Sponsors
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Centre Hospitalier Universitaire de Nice
OTHER
Responsible Party
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Principal Investigators
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Michel LANTERI-MINET
Role: PRINCIPAL_INVESTIGATOR
CHU de Nice département d'évaluation et traitement de la Douleur
Locations
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Hopitaux Civil de Colmar
Colmar, Haut-rhin, France
Clermont Ferrand CHU
Clermont-Ferrand, , France
Annecy Genevois CHU
Épagny, , France
Grenoble CHU
Grenoble, , France
Lille CHU
Lille, , France
Limoges CHU
Limoges, , France
HCL
Lyon, , France
APHM
Marseille, , France
Nancy CHU
Nancy, , France
Nantes CHU
Nantes, , France
Département d'Evaluation et Traitement de la Douleur
Nice, , France
AP-HP Lariboisière
Paris, , France
Adolphe de Rothschild Foundation
Paris, , France
Poitiers CHU
Poitiers, , France
Saint Etienne CHU
Saint-Etienne, , France
Foch Hospital
Suresnes, , France
Countries
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References
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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.
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.
Other Identifiers
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12-PP-08
Identifier Type: -
Identifier Source: org_study_id
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