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Report for Clinical Trial NCT02937727

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

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

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.

NCT02937727 Idiopathic Parkinson Patients

1 Interventions

Name: 3T MRI compatible and LFP recordable G106R of Beijing Pins medical.

Type: Device
Group Labels: 1

MRI compatible and LFP recordable implantable stimulator


Primary Outcomes

Measure: UPDRS part III

Time: 1 month,3 months, 6 months and 12months

Measure: Local Field Potential Recordings using G106R

Time: 1 month,3 months, 6 months and 12months

Secondary Outcomes

Measure: UPDRS part III

Time: 1, 3 months of stimulation

Measure: UPDRS part II

Time: 1, 3 months stimulation

Description: Drug Therapy are definied as levodopa equivalent dose,which is devodopa containing or dopamine agonist containing medications

Measure: Levodopa Equivalent Dose

Time: 1, 3 months stimulation

Measure: Local Field Potential Recordings using G106R

Time: 1 month, 3 months

Purpose: Treatment

Allocation: N/A

Single Group Assignment


There is one SNP

SNPs


1 G106R

The Chronically LFP recording using G106R is for two goals: 1) Evaluate the performance of long-term recordable neural simulation. --- G106R ---

Local Field Potential Recordings using G106R. --- G106R ---



HPO Nodes