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

Phase 1

• Conditions: Idiopathic Parkinson Patients

• Registration Number: NCT02937727
• Lead Sponsor: Beijing Pins Medical Co., Ltd

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2016-10
• Study First Submitted: 2016-10-13
• Study First Submitted QC: 2016-10-16
• Study First Posted: 2016-10-19
• Study Start: 2016-11
• Last Update Submitted: 2017-06-22
• Last Update Posted: 2017-06-23
• Primary Completion: 2017-10
• Study Completion: 2018-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Local Field Potential Recordings using G106R	1 month,3 months, 6 months and 12months
UPDRS part III	1 month,3 months, 6 months and 12months

Secondary Outcome Measures

Name	Time	Method
UPDRS part III	1, 3 months of stimulation
UPDRS part II	1, 3 months stimulation
Local Field Potential Recordings using G106R	1 month, 3 months
Levodopa Equivalent Dose	1, 3 months stimulation	Drug Therapy are definied as levodopa equivalent dose,which is devodopa containing or dopamine agonist containing medications

Trial Locations

Locations (3)

Beijing Tiantan Hospital; 🇨🇳 Beijing, Beijing, China

Peking Union Medical College Hospital; 🇨🇳 Beijing, Beijing, China

Qilu Hospital of Shandong University; 🇨🇳 Jinan, Shandong, China