French Database of Occipital Nerves Stimulation in the Treatment of Refractory Chronic Headache Disorders (NGO)
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|ClinicalTrials.gov Identifier: NCT01842763|
Recruitment Status : Recruiting
First Posted : April 30, 2013
Last Update Posted : March 21, 2016
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.
|Condition or disease|
|Refractory Chronic Headache Disorders|
|Study Type :||Observational|
|Estimated Enrollment :||50 participants|
|Official Title:||French Database of Occipital Nerves Stimulation in the Treatment of Refractory Chronic Headache Disorders|
|Study Start Date :||March 2013|
|Estimated Primary Completion Date :||December 2016|
|Estimated Study Completion Date :||December 2016|
- observation of a disease or medical condition under normal conditions [ Time Frame: at each visit (up to 4 years) ]ocial 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01842763
|Contact: Michel LANTERI-MINET, Dr||04 92 03 79 firstname.lastname@example.org|
|Département d'Evaluation et Traitement de la Douleur||Recruiting|
|Nice, France, 06000|
|Contact: Michel LANTERI-MINET, Dr 04 92 03 79 46|
|Contact: Sylvie ROMETTINO, DEDT study coordinator 04 92 03 84 81 email@example.com|
|Sub-Investigator: Denys FONTAINE, Dr|
|Sub-Investigator: Gabriela CARELLI, Dr|
|Sub-Investigator: Jimmy VOIRIN, Dr|
|Principal Investigator: Michel LANTERI-MINET, Dr|
|Principal Investigator:||Michel LANTERI-MINET||CHU de Nice département d'évaluation et traitement de la Douleur|