Informations générales (source: ClinicalTrials.gov)

NCT01842763 Active, sans recrutement
French Database of Occipital Nerves Stimulation in the Treatment of Refractory Chronic Headache Disorders (NGO)
Observational
  • Céphalée
  • Céphalées
Centre Hospitalier Universitaire de Nice (Voir sur ClinicalTrials)
mars 2013
septembre 2027
05 avril 2025
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.

Etablissements

Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données
HOPITAL FOCH Contact (sur clinicalTrials)
Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données
Département d'Evaluation et Traitement de la Douleur - 06000 - Nice - France Contact (sur clinicalTrials)
Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données
Adolphe de Rothschild Foundation - 75940 - Paris - France Contact (sur clinicalTrials)
Annecy Genevois CHU - 74370 - Épagny - France Contact (sur clinicalTrials)
APHM - 13354 - Marseille - France Contact (sur clinicalTrials)
AP-HP Lariboisière - 75184 - Paris - France Contact (sur clinicalTrials)
Clermont Ferrand CHU - 63003 - Clermont-Ferrand - France Contact (sur clinicalTrials)
Grenoble CHU - 38043 - Grenoble - France Contact (sur clinicalTrials)
HCL - 69229 - Lyon - France Contact (sur clinicalTrials)
Hopitaux Civil de Colmar - 68024 - Colmar - Haut-rhin - France Contact (sur clinicalTrials)
Lille CHU - 59037 - Lille - France Contact (sur clinicalTrials)
Limoges CHU - 87000 - Limoges - France Contact (sur clinicalTrials)
Nancy CHU - 54035 - Nancy - France Contact (sur clinicalTrials)
Nantes CHU - 44093 - Nantes - France Contact (sur clinicalTrials)
Poitiers CHU - 86021 - Poitiers - France Contact (sur clinicalTrials)
Saint Etienne CHU - 42055 - Saint-Étienne - France Contact (sur clinicalTrials)

Critères

Tous
Inclusion Criteria:

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



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