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DBS of the Third Ventricle for Cluster Headache and Obesity (DBS V3)

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ClinicalTrials.gov Identifier: NCT02782533
Recruitment Status : Recruiting
First Posted : May 25, 2016
Last Update Posted : January 18, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
Study of Deep Brain Stimulation of the Third ventricle in Cluster Headache and Obesity treatment.

Condition or disease Intervention/treatment
Cluster Headache Obesity Device: Deep Brain Stimulation V3

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : November 2008
Estimated Primary Completion Date : November 2018
Estimated Study Completion Date : November 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Headache
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: DBS V3
Deep Brain Stimulation V3
Device: Deep Brain Stimulation V3


Outcome Measures

Primary Outcome Measures :
  1. Quality of Life Questionnaire [ Time Frame: weekly up to 3 years ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria :

  • Male or female aged between 18 and 65 years
  • Ambulatory or hospitalized monitoring
  • Fluent in French and able to understand the study procedures, including completing the auto-questionnaires
  • Registered in the French social security scheme
  • Signed informed consent of the patient will be collected before inclusion in the study
  • Cluster Headache or Obesity patients

Exclusion Criteria:

  • Contraindication to Magnetoencephalography (MEG) and/or Electroencephalography (EEG)
  • Contraindication to Magnetic resonance imaging (MRI)
  • All categories of protected persons
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02782533


Contacts
Contact: Stéphan CHABARDES, MD, PhD SChabardes@chu-grenoble.fr
Contact: Caroline Sandre-Ballester, PhD + 33 4 38 78 28 51 csandreballester@chu-grenoble.fr

Locations
France
CLINATEC Recruiting
Grenoble, France, 38000
Contact: Stéphan CHABARDES, MD, PhD       SChabardes@chu-grenoble.fr   
Contact: Caroline Sandre-Ballester, PhD    + 33 4 38 78 28 51    csandreballester@chu-grenoble.fr   
Principal Investigator: Stéphan CHABARDES, MD, PhD         
Sponsors and Collaborators
University Hospital, Grenoble
More Information

Responsible Party: University Hospital, Grenoble
ClinicalTrials.gov Identifier: NCT02782533     History of Changes
Other Study ID Numbers: CHU Grenoble
First Posted: May 25, 2016    Key Record Dates
Last Update Posted: January 18, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Obesity
Headache
Cluster Headache
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Pain
Neurologic Manifestations
Nervous System Diseases
Trigeminal Autonomic Cephalalgias
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases