Multi-electrodes Set for Deep Brain Stimulation in Parkinson Disease

Early Phase 1

Terminated

• Conditions: Parkinson Disease
• Interventions: Device: 32 channels Deep Brain Stimulator

• Registration Number: NCT02402569
• Lead Sponsor: University Hospital, Grenoble

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.

Study Timeline

• Study Start: 2014-12
• Study First Submitted: 2015-01-30
• Study First Submitted QC: 2015-03-24
• Study First Posted: 2015-03-30
• Primary Completion: 2018-12
• Study Completion: 2018-12
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-07
• Last Update Posted: 2019-01-09

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 2

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Single-electrode / Multi electrodes	32 channels Deep Brain Stimulator	Single stimulation / Multi stimulation
Multi-electrodes / single electrode	32 channels Deep Brain Stimulator	Multi stimulation / single stimulation

Primary Outcome Measures

Name	Time	Method
Safety, as measured by Number of Participants with Adverse Events	3 months	Number of Participants with Adverse Events

Secondary Outcome Measures

Name	Time	Method
Neurologic evaluation	3 months	Change in motor and non-motor symptoms assessment with neurologic scales

Trial Locations

Locations (1)

CLINATEC; 🇫🇷 Grenoble, France