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

Beijing Pins Medical

Status and phase: Unknown; Phase 1

Conditions: Idiopathic Parkinson Patients

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT02937727

PINS-021

Details and patient eligibility

About

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.

Enrollment: 10 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

MRI compatible and LFP recordable implantable stimulator

Experimental group

Treatment:

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