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

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02782533
Recruitment Status : Completed
First Posted : May 25, 2016
Last Update Posted : July 19, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital, Grenoble

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

Condition or disease Intervention/treatment Phase
Cluster Headache Obesity Device: Deep Brain Stimulation V3 Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : November 2008
Actual Primary Completion Date : June 2019
Actual Study Completion Date : June 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Headache

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



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


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older 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

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


Locations
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France
CLINATEC
Grenoble, France, 38000
Sponsors and Collaborators
University Hospital, Grenoble
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Responsible Party: University Hospital, Grenoble
ClinicalTrials.gov Identifier: NCT02782533    
Other Study ID Numbers: CHU Grenoble
First Posted: May 25, 2016    Key Record Dates
Last Update Posted: July 19, 2019
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Cluster Headache
Obesity
Headache
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Pain
Neurologic Manifestations
Trigeminal Autonomic Cephalalgias
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases