Back to resultsDBS of the Third Ventricle for Cluster Headache and Obesity (DBS V3)
Primary Purpose
Cluster Headache, Obesity
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Deep Brain Stimulation V3
Sponsored by
About this trial
This is an interventional treatment trial for Cluster Headache
Eligibility 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
Sites / Locations
- CLINATEC
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
DBS V3
Arm Description
Deep Brain Stimulation V3
Outcomes
Primary Outcome Measures
Quality of Life Questionnaire
Secondary Outcome Measures
Full Information
NCT ID
NCT02782533
First Posted
May 12, 2016
Last Updated
July 17, 2019
Sponsor
University Hospital, Grenoble
1. Study Identification
Unique Protocol Identification Number
NCT02782533
Brief Title
DBS of the Third Ventricle for Cluster Headache and Obesity
Acronym
DBS V3
Study Type
Interventional
2. Study Status
Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
November 2008 (undefined)
Primary Completion Date
June 2019 (Actual)
Study Completion Date
June 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Grenoble
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Study of Deep Brain Stimulation of the Third ventricle in Cluster Headache and Obesity treatment.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cluster Headache, Obesity
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
13 (Actual)
8. Arms, Groups, and Interventions
Arm Title
DBS V3
Arm Type
Experimental
Arm Description
Deep Brain Stimulation V3
Intervention Type
Device
Intervention Name(s)
Deep Brain Stimulation V3
Primary Outcome Measure Information:
Title
Quality of Life Questionnaire
Time Frame
weekly up to 3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
CLINATEC
City
Grenoble
ZIP/Postal Code
38000
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
DBS of the Third Ventricle for Cluster Headache and Obesity
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