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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

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

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.


Detailed Summary:
Sponsor: Centre Hospitalier Universitaire de Nice

Current Primary Outcome: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Centre Hospitalier Universitaire de Nice

Dates:
Date Received: March 22, 2013
Date Started: March 2013
Date Completion: December 2016
Last Updated: March 18, 2016
Last Verified: March 2016