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

Beijing Pins Medical

Status and phase: Unknown; Phase 2

Conditions: Parkinson's Disease

Treatments: Device: Beijing PINS Programming

Study type: Interventional

Funder types: Industry

Identifiers

NCT02929628

PINS-020

Details and patient eligibility

About

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.

Enrollment: 106 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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106 participants in 2 patient groups

Patients with Various Frequency Stimulation

Experimental group

Description:

Patients are in the condition of Various Frequency Stimulation

Treatment:

Device: Beijing PINS Programming

Patients With Traditional Frequency Stimulation

Sham Comparator group

Description:

Patients in the condition of Sham Comparator are Traditional Frequency Stimulation

Treatment:

Device: Beijing PINS Programming