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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-30

Study Completion Date

2018-03-31

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.

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Detailed Description

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Conditions

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Idiopathic Parkinson Patients

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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MRI compatible and LFP recordable implantable stimulator

Group Type EXPERIMENTAL

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

Intervention Type DEVICE

Interventions

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

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Age ≥18，≤75，idiopathic Parkinson's disease，both male and female
2. MMSE score ≥24
3. H-Y score ≥2.0 on the medicine off situation
4. UPDRS-III score≥30 on the medicine off situation
5. The duration of this disease ≥5 years
6. Ability to provide informed consent as determined by preoperative neuropsychological assessment
7. 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
8. Excellent responsiveness to levodopa
9. ≥6h in medicine off state

Exclusion Criteria

1. Lack of ability to provide informed consent as determined by preoperative neuropsychological assessment
2. Otherwise not eligible for DBS surgery, for example known inability to undergo anesthesia
3. Hydrocephalus，brain atrophy，cerebral infarction ，cerebralvascular diseases
4. Patients who are unable to follow verbal instructions
5. Other severe pathological chronic condition that might confound treatment effects or interpretation of the data

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No