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

Grenoble Alpes University Hospital Center (CHU)

Status and phase: Terminated; Early Phase 1

Conditions: Parkinson Disease

Treatments: Device: 32 channels Deep Brain Stimulator

Study type: Interventional

Funder types: Other

Identifiers

NCT02402569

SIV2

Details and patient eligibility

About

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

Full description

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

Enrollment: 2 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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2 participants in 2 patient groups

Multi-electrodes / single electrode

Experimental group

Description:

Multi stimulation / single stimulation

Treatment:

Device: 32 channels Deep Brain Stimulator

Single-electrode / Multi electrodes

Experimental group

Description:

Single stimulation / Multi stimulation

Treatment:

Device: 32 channels Deep Brain Stimulator