Parkinson Disease
Conditions
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.
Interventions
DEVICE32 channels Deep Brain Stimulator
Sponsors
University Hospital, Grenoble
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety, as measured by Number of Participants with Adverse Events | 3 months | Number of Participants with Adverse Events |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Neurologic evaluation | 3 months | Change in motor and non-motor symptoms assessment with neurologic scales |
Countries
France
Outcome results
None listed