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

Beijing Pins Medical Co., Ltd106 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

106

Conditions

Parkinson's Disease

Interventions

Beijing PINS Programming

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Changs in the score of Stand-Walk-Sit Test

Time frame: 1、3、6 and 12 month

Secondary Outcomes

Change of the score in UPDRS

Time frame: 1,3,6,12 months of Various Frequency Stimulation

Change of the score in PDQ-39

Time frame: 1、3、6、12 months of Various Frequency Stimulation

Change of the score in the FOG-Q

Time frame: 1、3、6、12 month of Various Frequency Stimulation