Evaluate the Safety and Effectiveness of Various Frequency Stimulation for Patients With Parkinson's Disease

Study Overview
=================
Brief Summary
-----------------
Patients with an implantable electrical nerve stimulation system Patient criteria included: over 18 years of age,MMSE≥ 24 score; H-Y stage in medicine off condition>2.0;an ability to walk at least 10 meters independently;subscore≥2 for UPDRS part II item 15;subscore >1 for UPDRS part II item 14; permissions given by informed consent. Patients with serious diseases such as tumor, sever liver or kidney dysfunction were not selected in the clinical trials. Subjects participating in other clinical trials related or not related to these trials were not chosen.

Official Title
-----------------
Evaluate the Safety and Effectiveness Between Various Frequency Stimulation and Traditional High Frequency Stimulation for the Treatment of Patients With Parkinson's Disease

Conditions
-----------------
Parkinson's Disease

Intervention / Treatment
-----------------
* Device: Beijing PINS Programming


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age >18 years of age,male or female patients idiopathic Parkinson's disease had deep brain stimulaton implant H-Y>2.0 in the absence of L-dopa UPDRSII-14 item ≥1 UPDRSII-15 item ≥2 an ability to walk at least 10 meters independently Exclusion Criteria: Patients with serious diseases such as tumor, sever liver or kidney dysfunction were not selected in the clinical trials epilepsy Pregnant female History of severe neuropsychiatric disease Patients are taking part in other clinical trials in recent several months

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patients with Various Frequency Stimulation<br>Patients are in the condition of Various Frequency Stimulation | Device: Beijing PINS Programming<br>* Using the programming control the Stimulator to change the parameter<br>|
| Sham Comparator: Patients With Traditional Frequency Stimulation<br>Patients in the condition of Sham Comparator are Traditional Frequency Stimulation | Device: Beijing PINS Programming<br>* Using the programming control the Stimulator to change the parameter<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changs in the score of Stand-Walk-Sit Test |  | 1、3、6 and 12 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of the score in UPDRS |  | 1,3,6,12 months of Various Frequency Stimulation | 
| Change of the score in PDQ-39 |  | 1、3、6、12 months of Various Frequency Stimulation | 
| Change of the score in the FOG-Q |  | 1、3、6、12 month of Various Frequency Stimulation |