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

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.

Study Overview

• Status: Unknown
• Conditions: Idiopathic Parkinson Patients
• Intervention / Treatment: Device: 3T MRI compatible and LFP recordable G106R of Beijing Pins medical.

• Study Type: Interventional
• Enrollment (Anticipated): 10
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Fumin Jia, PhD; Phone Number: 010-60736388
• Study Contact Backup: Name: Luming Li, PhD; Phone Number: 010-60736388

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100050
      • Recruiting
      • Beijing Tiantan Hospital
    • Beijing, Beijing, China
      • Recruiting
      • Peking Union Medical College Hospital
      • Contact: Wenbin Ma, MD; Phone Number: 010-69152530
  • Shandong
    • Jinan, Shandong, China, 250012
      • Recruiting
      • Qilu Hospital of Shandong University
      • Contact: Shujun Xu, MD; Phone Number: 0531-82166631; Email: xu-shujunql@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Beijing Pins Medical Co., Ltd

Study record dates

Study Major Dates

• Study Start: November 1, 2016
• Primary Completion (Anticipated): October 1, 2017
• Study Completion (Anticipated): March 1, 2018

Study Registration Dates

• First Submitted: October 13, 2016
• First Submitted That Met QC Criteria: October 16, 2016
• First Posted (Estimate): October 19, 2016

Study Record Updates

• Last Update Posted (Actual): June 23, 2017
• Last Update Submitted That Met QC Criteria: June 22, 2017
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: PINS-021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes