MRI Compatible and Long-term LFP Recordable Deep Brain Stimulation on PD Patients

Study Overview
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Brief Summary
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Deep Brain Stimulation represents the golden standard for surgical treatment of Parkinson's disease (PD), but it is not optimally effective for controlling every motor sign and adverse events are not so infrequent. Therefore,other approaches should be considered. New Approaches in MRI at 3T and long-term local field potential (LFP) recording are very important to target subthalamic nucleus (STN) and understand mechanisms of DBS on Parkinson Patients. This study aims at evaluating the safety and effectiveness of 3T MRI Compatible and LFP recordable deep brain stimulation on PD patients. The Chronically LFP recording using G106R is for two goals: 1) Evaluate the performance of long-term recordable neural simulation. 2) Study long-term clinical and electrophysiology effects of deep brain stimulation on STN.

Official Title
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Evaluate the Safety and Effectiveness of 3T MRI Compatible and Long-term LFP Recordable Deep Brain Stimulation on PD Patients

Conditions
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Idiopathic Parkinson Patients

Intervention / Treatment
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* Device: 3T MRI compatible and LFP recordable G106R of Beijing Pins medical.


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥18，≤75，idiopathic Parkinson's disease，both male and female MMSE score ≥24 H-Y score ≥2.0 on the medicine off situation UPDRS-III score≥30 on the medicine off situation The duration of this disease ≥5 years Ability to provide informed consent as determined by preoperative neuropsychological assessment History of appropriate response to dopaminergic medication, with at least a 30% improvement in motor UPDRS with L-DOPA by history or in-clinic testing, for the PD patients Excellent responsiveness to levodopa ≥6h in medicine off state Exclusion Criteria: Lack of ability to provide informed consent as determined by preoperative neuropsychological assessment Otherwise not eligible for DBS surgery, for example known inability to undergo anesthesia Hydrocephalus，brain atrophy，cerebral infarction ，cerebralvascular diseases Patients who are unable to follow verbal instructions Other severe pathological chronic condition that might confound treatment effects or interpretation of the data

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MRI compatible and LFP recordable implantable stimulator<br> | Device: 3T MRI compatible and LFP recordable G106R of Beijing Pins medical.<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| UPDRS part III |  | 1 month,3 months, 6 months and 12months | 
| Local Field Potential Recordings using G106R |  | 1 month,3 months, 6 months and 12months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| UPDRS part III |  | 1, 3 months of stimulation | 
| UPDRS part II |  | 1, 3 months stimulation | 
| Levodopa Equivalent Dose | Drug Therapy are definied as levodopa equivalent dose,which is devodopa containing or dopamine agonist containing medications | 1, 3 months stimulation | 
| Local Field Potential Recordings using G106R |  | 1 month, 3 months |