Multi-electrodes Set for Deep Brain Stimulation in Parkin... | NCT02402569

Studies
Multi-electrodes Set for Deep Brain Stimulation in Parkinson Disease

NCT02402569

Sponsor

University Hospital, Grenoble

Status

Terminated

Last Update Posted

Jan 9, 2019Actual

Enrollment

2Actual

Phase

Early Phase 1

Conditions

Parkinson Disease

Interventions

32 channels Deep Brain Stimulator

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

Jan 2019

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2014

Primary Completion Date

Dec 2018Actual

Completion Date

Dec 2018Actual

First Submitted Date

Jan 30, 2015

First Submission Date that Met QC Criteria

Mar 24, 2015

First Posted Date

Mar 30, 2015Estimated

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

Jan 7, 2019

Last Update Posted Date

Jan 9, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

Description Module

Brief Summary

This study aims to demonstrate innocuity and feasibility of deep brain stimulation with a multi-electrodes set.

Detailed Description

Bilateral stimulation in subthalamic nucleus with the multi-electrodes set will be compared with single electrode.

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

Early Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

2Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Multi-electrodes / single electrode	Experimental	Multi stimulation / single stimulation	Device: 32 channels Deep Brain Stimulator
Single-electrode / Multi electrodes	Experimental	Single stimulation / Multi stimulation	Device: 32 channels Deep Brain Stimulator

Interventions

Name	Type	Description	Arm Group Labels	Other Names
32 channels Deep Brain Stimulator	Device		Multi-electrodes / single electrode Single-electrode / Multi electrodes

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Safety, as measured by Number of Participants with Adverse Events	Number of Participants with Adverse Events	3 months

Secondary Outcomes

Measure	Description	Time Frame
Neurologic evaluation	Change in motor and non-motor symptoms assessment with neurologic scales	3 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

more or equal than 18 years old and less than 70 years
patient affiliated to social security or similarly regime
informed consent form signed
parkinson disease (UPDRS III20 score up than 30/108 except for severe tremors)
motor and non motor dysfunctions
pre-operative cerebral MRI without lesion
without chirurgical contraindications
without psychiatric disease

Exclusion Criteria:

Pregnant women and lactating mothers
Ward of court or under guardianship
Adult unable to express their consent
Person deprived of freedom by judicial or administrative decision
Person hospitalized without their consent
Person under legal protection
Person with carcinological antecedent during precedent 5 years
Chirurgical or MRI contraindications

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
CLINATEC		Grenoble		38000	France

Condition Browse Module

MeSH Terms

ID	Term
D010300	Parkinson Disease

Ancestor Terms

ID	Term
D020734	Parkinsonian Disorders
D001480	Basal Ganglia Diseases
D001927	Brain Diseases
D002493	Central Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided