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

NCT02929628 | Unknown Phase 2 DMC

• 1 other identifier: PINS-020
• Study Type: interventional
• Target: 106
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• Changs in the score of Stand-Walk-Sit Test

  1、3、6 and 12 month

Secondary Outcomes (3)

• 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

Study Arms (2)

Patients with Various Frequency Stimulation

EXPERIMENTAL

Patients are in the condition of Various Frequency Stimulation

Device: Beijing PINS Programming

Patients With Traditional Frequency Stimulation

SHAM COMPARATOR

Patients in the condition of Sham Comparator are Traditional Frequency Stimulation

Device: Beijing PINS Programming

Interventions

Beijing PINS Programming DEVICE

Using the programming control the Stimulator to change the parameter

Patients With Traditional Frequency Stimulation; Patients with Various Frequency Stimulation

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Beijing Pins Medical Co., Ltd: lead

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 8, 2016
• First Posted: October 11, 2016
• Study Start: December 1, 2016
• Primary Completion: August 1, 2017
• Study Completion: November 1, 2017
• Last Updated: October 13, 2016

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will share