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

January 7, 2019 updated by: University Hospital, Grenoble

Implantation Feasibility Study of a Multi-electrodes Set for Deep Brain Stimulation in Parkinson Disease (Smart in Vivo 2)

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

2

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Grenoble, France, 38000
        • CLINATEC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Multi-electrodes / single electrode
Multi stimulation / single stimulation
Device: 32 channels Deep Brain Stimulator
Experimental: Single-electrode / Multi electrodes
Single stimulation / Multi stimulation
Device: 32 channels Deep Brain Stimulator

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Grenoble

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2014

Primary Completion (Actual)

December 1, 2018

Study Completion (Actual)

December 1, 2018

Study Registration Dates

First Submitted

January 30, 2015

First Submitted That Met QC Criteria

March 24, 2015

First Posted (Estimate)

March 30, 2015

Study Record Updates

Last Update Posted (Actual)

January 9, 2019

Last Update Submitted That Met QC Criteria

January 7, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SIV2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Parkinson Disease

Clinical Trials on 32 channels Deep Brain Stimulator

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Australia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe