Clinical trial NCT01842763: French Database of Occipital Nerves Stimulation in the Treatment of Refractory Chronic Headache Disorders
Official title: French Database of Occipital Nerves Stimulation in the Treatment of Refractory Chronic Headache Disorders
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Refractory Chronic Headache Disorders
Keywords: Chronic daily headache
treated by occipital nerves stimulation
peripheral neuromodulation
occipital nerves
network
database
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2013-04-30
Enrollment: 246
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
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

Brief 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 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.


Eligibility criteria: 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

Primary outcomes:
measure: observation of a disease or medical condition under normal conditions
timeFrame: at each visit (up to 4 years)
Secondary outcomes:
Other outcomes:
Locations:
city: Colmar
country: France
facility: Hopitaux Civil de Colmar
state: Haut-rhin
city: Clermont-Ferrand
country: France
facility: Clermont Ferrand CHU
city: Grenoble
country: France
facility: Grenoble CHU
city: Lille
country: France
facility: Lille CHU
city: Limoges
country: France
facility: Limoges CHU
city: Lyon
country: France
facility: HCL
city: Marseille
country: France
facility: APHM
city: Nancy
country: France
facility: Nancy CHU
city: Nantes
country: France
facility: Nantes CHU
city: Nice
country: France
facility: Département d'Evaluation et Traitement de la Douleur
city: Paris
country: France
facility: AP-HP Lariboisière
city: Paris
country: France
facility: Adolphe de Rothschild Foundation
city: Poitiers
country: France
facility: Poitiers CHU
city: Saint-Étienne
country: France
facility: Saint Etienne CHU
city: Suresnes
country: France
facility: Foch Hospital
city: Épagny
country: France
facility: Annecy Genevois CHU
Study officials:
affiliation: CHU de Nice département d'évaluation et traitement de la Douleur
name: Michel LANTERI-MINET
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.