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

Active, not recruiting

• Conditions: Refractory Chronic Headache Disorders

• Registration Number: NCT01842763
• Lead Sponsor: Centre Hospitalier Universitaire de Nice

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 Description

Not available

Study Timeline

• Study Start: 2013-03
• Study First Submitted: 2013-03-22
• Study First Submitted QC: 2013-04-29
• Study First Posted: 2013-04-30
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-17
• Last Update Posted: 2025-03-18
• Primary Completion: 2027-09
• Study Completion: 2027-09

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 246

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
observation of a disease or medical condition under normal conditions	at each visit (up to 4 years)	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.

Trial Locations

Locations (16)

Hopitaux Civil de Colmar; 🇫🇷 Colmar, Haut-rhin, France

Clermont Ferrand CHU; 🇫🇷 Clermont-Ferrand, 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-Étienne, France

Foch Hospital; 🇫🇷 Suresnes, France

Annecy Genevois CHU; 🇫🇷 Épagny, France