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

October 12, 2016 updated by: Beijing Pins Medical Co., Ltd

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

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 Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

106

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Patients with Various Frequency Stimulation
Patients are in the condition of Various Frequency Stimulation
Device: Beijing PINS Programming
Using the programming control the Stimulator to change the parameter
Sham Comparator: Patients With Traditional Frequency Stimulation
Patients in the condition of Sham Comparator are Traditional Frequency Stimulation
Device: Beijing PINS Programming
Using the programming control the Stimulator to change the parameter

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Changs in the score of Stand-Walk-Sit Test
Time Frame: 1、3、6 and 12 month
1、3、6 and 12 month

Secondary Outcome Measures

Outcome Measure
Time Frame
Change of the score in UPDRS
Time Frame: 1,3,6,12 months of Various Frequency Stimulation
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
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
1、3、6、12 month of Various Frequency Stimulation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beijing Pins Medical Co., Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2016

Primary Completion (Anticipated)

August 1, 2017

Study Completion (Anticipated)

November 1, 2017

Study Registration Dates

First Submitted

October 8, 2016

First Submitted That Met QC Criteria

October 8, 2016

First Posted (Estimate)

October 11, 2016

Study Record Updates

Last Update Posted (Estimate)

October 13, 2016

Last Update Submitted That Met QC Criteria

October 12, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PINS-020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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