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

NCT ID: NCT01842763

Last Updated: 2025-03-18

Study Results

Results pending

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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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

246 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-03-31

Study Completion Date

2027-09-30

Brief Summary

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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.

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.

Detailed Description

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Conditions

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Refractory Chronic Headache Disorders

Study Design

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Observational Model Type

OTHER

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

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

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire de Nice

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

Clermont Ferrand CHU

Clermont-Ferrand, , France

Site Status

Annecy Genevois CHU

Épagny, , France

Site Status

Grenoble CHU

Grenoble, , France

Site Status

Lille CHU

Lille, , France

Site Status

Limoges CHU

Limoges, , France

Site Status

HCL

Lyon, , France

Site Status

APHM

Marseille, , France

Site Status

Nancy CHU

Nancy, , France

Site Status

Nantes CHU

Nantes, , France

Site Status

Département d'Evaluation et Traitement de la Douleur

Nice, , France

Site Status

AP-HP Lariboisière

Paris, , France

Site Status

Adolphe de Rothschild Foundation

Paris, , France

Site Status

Poitiers CHU

Poitiers, , France

Site Status

Saint Etienne CHU

Saint-Etienne, , France

Site Status

Foch Hospital

Suresnes, , France

Site Status

Countries

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France

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.

Reference Type DERIVED
PMID: 35688701 (View on PubMed)

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.

Reference Type DERIVED
PMID: 27697849 (View on PubMed)

Other Identifiers

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12-PP-08

Identifier Type: -

Identifier Source: org_study_id

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