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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2013 by Centre Hospitalier Universitaire de Nice
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov Identifier:
NCT01842763
First received: March 22, 2013
Last updated: July 28, 2014
Last verified: January 2013
  Purpose

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.


Condition
Refractory Chronic Headache Disorders

Study Type: Observational
Study Design: Time Perspective: Cross-Sectional
Official Title: French Database of Occipital Nerves Stimulation in the Treatment of Refractory Chronic Headache Disorders

Resource links provided by NLM:


Further study details as provided by Centre Hospitalier Universitaire de Nice:

Primary Outcome Measures:
  • observation of a disease or medical condition under normal conditions [ Time Frame: at each visit (up to 4 years) ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 50
Study Start Date: March 2013
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
  Eligibility

Genders Eligible for Study:   Both
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

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01842763

Contacts
Contact: Michel LANTERI-MINET, Dr 04 92 03 79 46 lanteri-minet.m@chu-nice.fr

Locations
France
Département d'Evaluation et Traitement de la Douleur Recruiting
Nice, France, 06000
Contact: Michel LANTERI-MINET, Dr    04 92 03 79 46      
Contact: Sylvie ROMETTINO, DEDT study coordinator    04 92 03 84 81    rometti.s@chu-nice.fr   
Sub-Investigator: Denys FONTAINE, Dr         
Sub-Investigator: Gabriela CARELLI, Dr         
Sub-Investigator: Jimmy VOIRIN, Dr         
Principal Investigator: Michel LANTERI-MINET, Dr         
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nice
Investigators
Principal Investigator: Michel LANTERI-MINET CHU de Nice département d'évaluation et traitement de la Douleur
  More Information

No publications provided

Responsible Party: Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov Identifier: NCT01842763     History of Changes
Other Study ID Numbers: 12-PP-08
Study First Received: March 22, 2013
Last Updated: July 28, 2014
Health Authority: France: The Commission nationale de l’informatique et des libertés
France: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santé

Keywords provided by Centre Hospitalier Universitaire de Nice:
Chronic daily headache
treated by occipital nerves stimulation
peripheral neuromodulation
occipital nerves
network
database

Additional relevant MeSH terms:
Disease
Headache
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Pain
Pathologic Processes
Signs and Symptoms

ClinicalTrials.gov processed this record on November 20, 2014