Refractory Chronic Headache Disorders Clinical Trial
— NGOOfficial title:
French Database of Occipital Nerves Stimulation in the Treatment of Refractory Chronic Headache Disorders
| NCT number | NCT01842763 |
| Other study ID # | 12-PP-08 |
| Secondary ID | |
| Status | Recruiting |
| Phase | |
| First received | |
| Last updated | |
| Start date | March 2013 |
| Est. completion date | January 2028 |
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.
| Status | Recruiting |
| Enrollment | 240 |
| Est. completion date | January 2028 |
| Est. primary completion date | January 2028 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | N/A and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| France | Clermont Ferrand CHU | Clermont-Ferrand | |
| France | Hopitaux Civil de Colmar | Colmar | Haut-rhin |
| 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 | Adolphe de Rothschild Foundation | Paris | |
| France | AP-HP Lariboisière | Paris | |
| France | Poitiers CHU | Poitiers | |
| France | Saint Etienne CHU | Saint-Étienne | |
| France | Foch Hospital | Suresnes |
| Lead Sponsor | Collaborator |
|---|---|
| Centre Hospitalier Universitaire de Nice |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | observation of a disease or medical condition under normal conditions | 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. | at each visit (up to 4 years) |