Multi-electrodes Set for Deep Brain Stimulation in Parkinson Disease

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

EARLY_PHASE1

Total Enrollment

2 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-12-31

Study Completion Date

2018-12-31

Brief Summary

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

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Detailed Description

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

Conditions

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Parkinson Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Multi-electrodes / single electrode

Multi stimulation / single stimulation

Group Type EXPERIMENTAL

32 channels Deep Brain Stimulator

Intervention Type DEVICE

Single-electrode / Multi electrodes

Single stimulation / Multi stimulation

Group Type EXPERIMENTAL

32 channels Deep Brain Stimulator

Intervention Type DEVICE

Interventions

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32 channels Deep Brain Stimulator

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No