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

Phase 2

• Conditions: Parkinson's Disease
• Interventions: Device: Beijing PINS Programming

• Registration Number: NCT02929628
• Lead Sponsor: Beijing Pins Medical Co., Ltd

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2016-10
• Study First Submitted: 2016-10-08
• Study First Submitted QC: 2016-10-08
• Study First Posted: 2016-10-11
• Last Update Submitted: 2016-10-12
• Last Update Posted: 2016-10-13
• Study Start: 2016-12
• Primary Completion: 2017-08
• Study Completion: 2017-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 106

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Patients With Traditional Frequency Stimulation	Beijing PINS Programming	Patients in the condition of Sham Comparator are Traditional Frequency Stimulation
Patients with Various Frequency Stimulation	Beijing PINS Programming	Patients are in the condition of Various Frequency Stimulation

Primary Outcome Measures

Name	Time	Method
Changs in the score of Stand-Walk-Sit Test	1、3、6 and 12 month

Secondary Outcome Measures

Name	Time	Method
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
Change of the score in UPDRS	1,3,6,12 months of Various Frequency Stimulation