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

February 8, 2024 updated by: Centre Hospitalier Universitaire de Nice

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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

240

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Clermont-Ferrand, France, 63003
        • Recruiting
        • Clermont Ferrand CHU
        • Contact:
          • Xavier MOISSET
        • Sub-Investigator:
          • Denis SINARDET
        • Sub-Investigator:
          • Xavier MOISSET
      • Grenoble, France, 38043
        • Recruiting
        • Grenoble CHU
        • Contact:
          • Stéphan CHABARDES
        • Sub-Investigator:
          • Stéphan CHABARDES
        • Sub-Investigator:
          • Jean Pierre ALIBEU
        • Sub-Investigator:
          • Hasan HODAJ
      • Lille, France, 59037
        • Recruiting
        • Lille CHU
        • Principal Investigator:
          • Christian LUCAS
        • Contact:
          • Christian LUCAS
      • Limoges, France, 87000
        • Recruiting
        • Limoges CHU
        • Contact:
          • Claire FRANCOIS
        • Principal Investigator:
          • Claire FRANCOIS
      • Lyon, France, 69229
        • Recruiting
        • HCL
        • Contact:
          • Patrick MERTENS
        • Sub-Investigator:
          • Patrick METENS
        • Sub-Investigator:
          • Emile SIMONS
      • Marseille, France, 13354
        • Recruiting
        • APHM
        • Contact:
          • Jean REGIS
        • Sub-Investigator:
          • Jean REGIS
        • Sub-Investigator:
          • Anne DONET
      • Nancy, France, 54035
        • Recruiting
        • Nancy CHU
        • Contact:
          • Sophie COLNAT-COULBOIS
        • Sub-Investigator:
          • Philippe LONCHAMP
        • Sub-Investigator:
          • Sophie COLNAT-COULBOIS
      • Nantes, France, 44093
        • Recruiting
        • Nantes CHU
        • Contact:
          • Emmanuelle KUHN
        • Principal Investigator:
          • Emmanuelle KUHN
      • Nice, France, 06000
        • Recruiting
        • Département d'Evaluation et Traitement de la Douleur
        • Contact:
          • Michel LANTERI-MINET, Dr
          • Phone Number: 04 92 03 79 46
        • Contact:
        • Sub-Investigator:
          • Denys FONTAINE, Dr
        • Sub-Investigator:
          • Gabriela CARELLI, Dr
        • Sub-Investigator:
          • Jimmy VOIRIN, Dr
        • Principal Investigator:
          • Michel LANTERI-MINET, Dr
      • Paris, France, 75184
        • Recruiting
        • AP-HP Lariboisiere
        • Contact:
          • Jérome MAWET
        • Sub-Investigator:
          • Jerome MAWET
        • Sub-Investigator:
          • Caroline ROOS
      • Paris, France, 75940
        • Recruiting
        • Adolphe de Rothschild Foundation
        • Contact:
          • Hayat BELAID
        • Principal Investigator:
          • Hayat BELAID
      • Poitiers, France, 86021
        • Recruiting
        • Poitiers Chu
        • Contact:
          • Philippe RIGOARD
        • Principal Investigator:
          • Philippe RIGOARD
      • Saint-Étienne, France, 42055
        • Recruiting
        • Saint Etienne CHU
        • Contact:
          • Francois VASSAL
        • Sub-Investigator:
          • Francois VASSAL
        • Sub-Investigator:
          • Christelle CREAC'H
        • Sub-Investigator:
          • Roland PEYRON
      • Suresnes, France, 92150
        • Recruiting
        • Foch Hospital
        • Contact:
          • Béchir JARRAYA
        • Sub-Investigator:
          • Béchir JARRAYA
        • Sub-Investigator:
          • Bich DANG VU
        • Sub-Investigator:
          • Frédéric BOURDAIN
      • Épagny, France, 74370
        • Recruiting
        • Annecy Genevois CHU
        • Contact:
          • Pierric GIRAUD
        • Principal Investigator:
          • Pierric GIRAUD
    • Haut-rhin
      • Colmar, Haut-rhin, France, 68024
        • Recruiting
        • Hopitaux civil de Colmar
        • Contact:
        • Principal Investigator:
          • Jimmy VOIRIN

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients suffering from refractory chronic headache disorders (chronic migraine, cluster headache, chronic paroxysmal hemicranias, SUNCT syndrome (Short-lasting Unilateral Neuralgiform headache attacks with Conjunctival injection and Tearing), hemicrania continua, cervicogenic headache disorders) according to ICHD-II

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
observation of a disease or medical condition under normal conditions
Time Frame: 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.
at each visit (up to 4 years)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Nice

Investigators

  • Principal Investigator: Michel LANTERI-MINET, CHU de Nice département d'évaluation et traitement de la Douleur

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2013

Primary Completion (Estimated)

January 1, 2028

Study Completion (Estimated)

January 1, 2028

Study Registration Dates

First Submitted

March 22, 2013

First Submitted That Met QC Criteria

April 29, 2013

First Posted (Estimated)

April 30, 2013

Study Record Updates

Last Update Posted (Estimated)

February 9, 2024

Last Update Submitted That Met QC Criteria

February 8, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12-PP-08

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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