Multi-electrodes Set for Deep Brain Stimulation in Parkinson Disease

Early Phase 1TerminatedNCT02402569

University Hospital, Grenoble2 enrolled

Overview

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

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Parkinson Disease

Interventions

32 channels Deep Brain StimulatorDEVICE

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (1)

CLINATEC

Grenoble, France

Outcomes

Primary Outcomes

Safety, as measured by Number of Participants with Adverse Events

Number of Participants with Adverse Events

Time frame: 3 months

Secondary Outcomes

Neurologic evaluation

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

Time frame: 3 months

Data from ClinicalTrials.gov

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