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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
First Posted : October 19, 2016
Last Update Posted : June 23, 2017
Sponsor:
Information provided by (Responsible Party):
Beijing Pins Medical Co., Ltd

Study Description
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Brief Summary:
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 Intervention/treatment Phase
Idiopathic Parkinson Patients Device: 3T MRI compatible and LFP recordable G106R of Beijing Pins medical. Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluate the Safety and Effectiveness of 3T MRI Compatible and Long-term LFP Recordable Deep Brain Stimulation on PD Patients
Study Start Date : November 2016
Estimated Primary Completion Date : October 2017
Estimated Study Completion Date : March 2018

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Arms and Interventions
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Arm Intervention/treatment
Experimental: MRI compatible and LFP recordable implantable stimulator Device: 3T MRI compatible and LFP recordable G106R of Beijing Pins medical.


Outcome Measures
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Primary Outcome Measures :
  1. UPDRS part III [ Time Frame: 1 month,3 months, 6 months and 12months ]
  2. Local Field Potential Recordings using G106R [ Time Frame: 1 month,3 months, 6 months and 12months ]

Secondary Outcome Measures :
  1. UPDRS part III [ Time Frame: 1, 3 months of stimulation ]
  2. UPDRS part II [ Time Frame: 1, 3 months stimulation ]
  3. Levodopa Equivalent Dose [ Time Frame: 1, 3 months stimulation ]
    Drug Therapy are definied as levodopa equivalent dose,which is devodopa containing or dopamine agonist containing medications

  4. Local Field Potential Recordings using G106R [ Time Frame: 1 month, 3 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02937727


Contacts
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Contact: Fumin Jia, PhD 010-60736388
Contact: Luming Li, PhD 010-60736388

Locations
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China, Beijing
Beijing Tiantan Hospital Recruiting
Beijing, Beijing, China, 100050
Contact: Jianguo Zhang, MD    010-67096611    Limuxin2011@163.com   
Peking Union Medical College Hospital Recruiting
Beijing, Beijing, China
Contact: Wenbin Ma, MD    010-69152530      
China, Shandong
Qilu Hospital of Shandong University Recruiting
Jinan, Shandong, China, 250012
Contact: Shujun Xu, MD    0531-82166631    xu-shujunql@163.com   
Sponsors and Collaborators
Beijing Pins Medical Co., Ltd
More Information
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Responsible Party: Beijing Pins Medical Co., Ltd
ClinicalTrials.gov Identifier: NCT02937727    
Other Study ID Numbers: PINS-021
First Posted: October 19, 2016    Key Record Dates
Last Update Posted: June 23, 2017
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes