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Multi-electrodes Set for Deep Brain Stimulation in Parkinson Disease (SIV2)

Primary Purpose

Parkinson Disease

Status
Terminated
Phase
Early Phase 1
Locations
France
Study Type
Interventional
Intervention
32 channels Deep Brain Stimulator
Sponsored by
University Hospital, Grenoble
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson Disease

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CLINATEC

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Multi-electrodes / single electrode

Single-electrode / Multi electrodes

Arm Description

Multi stimulation / single stimulation

Single stimulation / Multi stimulation

Outcomes

Primary Outcome Measures

Safety, as measured by Number of Participants with Adverse Events
Number of Participants with Adverse Events

Secondary Outcome Measures

Neurologic evaluation
Change in motor and non-motor symptoms assessment with neurologic scales

Full Information

First Posted
January 30, 2015
Last Updated
January 7, 2019
Sponsor
University Hospital, Grenoble
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1. Study Identification

Unique Protocol Identification Number
NCT02402569
Brief Title
Multi-electrodes Set for Deep Brain Stimulation in Parkinson Disease
Acronym
SIV2
Official Title
Implantation Feasibility Study of a Multi-electrodes Set for Deep Brain Stimulation in Parkinson Disease (Smart in Vivo 2)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Terminated
Study Start Date
December 2014 (undefined)
Primary Completion Date
December 2018 (Actual)
Study Completion Date
December 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Grenoble

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Crossover Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
2 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Multi-electrodes / single electrode
Arm Type
Experimental
Arm Description
Multi stimulation / single stimulation
Arm Title
Single-electrode / Multi electrodes
Arm Type
Experimental
Arm Description
Single stimulation / Multi stimulation
Intervention Type
Device
Intervention Name(s)
32 channels Deep Brain Stimulator
Primary Outcome Measure Information:
Title
Safety, as measured by Number of Participants with Adverse Events
Description
Number of Participants with Adverse Events
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Neurologic evaluation
Description
Change in motor and non-motor symptoms assessment with neurologic scales
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
CLINATEC
City
Grenoble
ZIP/Postal Code
38000
Country
France

12. IPD Sharing Statement

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Multi-electrodes Set for Deep Brain Stimulation in Parkinson Disease

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