MRI Compatible and Long-term LFP Recordable Deep Brain Stimulation on PD Patients
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ClinicalTrials.gov Identifier: NCT02937727
Recruitment Status : Unknown
Verified October 2016 by Beijing Pins Medical Co., Ltd. Recruitment status was: Recruiting
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.
Condition or disease
Idiopathic Parkinson Patients
Device: 3T MRI compatible and LFP recordable G106R of Beijing Pins medical.
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Layout table for eligibility information
Ages Eligible for Study:
18 Years to 75 Years (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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
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