DBS of the Third Ventricle for Cluster Headache and Obesity | NCT02782533

Studies
DBS of the Third Ventricle for Cluster Headache and Obesity

NCT02782533

Sponsor

University Hospital, Grenoble

Status

Completed

Last Update Posted

Jul 19, 2019Actual

Enrollment

13Actual

Phase

Not Applicable

Conditions

Cluster Headache
Obesity

Interventions

Deep Brain Stimulation V3

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2008

Primary Completion Date

Jun 2019Actual

Completion Date

Jun 2019Actual

First Submitted Date

May 12, 2016

First Submission Date that Met QC Criteria

May 24, 2016

First Posted Date

May 25, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 17, 2019

Last Update Posted Date

Jul 19, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

13Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
DBS V3	Experimental	Deep Brain Stimulation V3	Device: Deep Brain Stimulation V3

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Deep Brain Stimulation V3	Device		DBS V3

Measure	Description	Time Frame
Quality of Life Questionnaire		weekly up to 3 years

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
CLINATEC		Grenoble		38000	France

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003027	Cluster Headache
D009765	Obesity

Ancestor Terms

ID	Term
D051303	Trigeminal Autonomic Cephalalgias
D051270	Headache Disorders, Primary
D020773	Headache Disorders
D001927	Brain Diseases

Browse Leaves

Not provided

Browse Branches

Not provided