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

NCT ID: NCT02929628

Last Updated: 2016-10-13

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 106 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-12-31
• Study Completion Date: 2017-11-30

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.

Conditions

Parkinson's Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Patients with Various Frequency Stimulation

Patients are in the condition of Various Frequency Stimulation

Group Type: EXPERIMENTAL

Beijing PINS Programming

Intervention Type: DEVICE

Using the programming control the Stimulator to change the parameter

Patients With Traditional Frequency Stimulation

Patients in the condition of Sham Comparator are Traditional Frequency Stimulation

Group Type: SHAM_COMPARATOR

Beijing PINS Programming

Intervention Type: DEVICE

Using the programming control the Stimulator to change the parameter

Interventions

Beijing PINS Programming

Using the programming control the Stimulator to change the parameter

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beijing Pins Medical Co., Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

PINS-020

Identifier Type: -

Identifier Source: org_study_id