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ACTIVE NOT RECRUITING
NCT01842763

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

Sponsor: Centre Hospitalier Universitaire de Nice

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

Any - Any

Study Type

OBSERVATIONAL

Enrollment

246

Start Date

2013-03

Completion Date

2027-09

Last Updated

2025-03-18

Healthy Volunteers

No

Locations (16)

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