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

This study is currently recruiting participants.
Verified January 2017 by University Hospital, Grenoble
Sponsor:
ClinicalTrials.gov Identifier:
NCT02782533
First Posted: May 25, 2016
Last Update Posted: January 18, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
University Hospital, Grenoble
  Purpose
Study of Deep Brain Stimulation of the Third ventricle in Cluster Headache and Obesity treatment.

Condition Intervention
Cluster Headache Obesity Device: Deep Brain Stimulation V3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by University Hospital, Grenoble:

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

Estimated Enrollment: 15
Study Start Date: November 2008
Estimated Study Completion Date: November 2018
Estimated Primary Completion Date: November 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: DBS V3
Deep Brain Stimulation V3
Device: Deep Brain Stimulation V3

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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 Submitted: May 12, 2016
First Posted: May 25, 2016
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