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

Primary Purpose

Parkinson's Disease

Status
Unknown status
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Beijing PINS Programming
Sponsored by
Beijing Pins Medical Co., Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson's Disease

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Sham Comparator

    Arm Label

    Patients with Various Frequency Stimulation

    Patients With Traditional Frequency Stimulation

    Arm Description

    Patients are in the condition of Various Frequency Stimulation

    Patients in the condition of Sham Comparator are Traditional Frequency Stimulation

    Outcomes

    Primary Outcome Measures

    Changs in the score of Stand-Walk-Sit Test

    Secondary Outcome Measures

    Change of the score in UPDRS
    Change of the score in PDQ-39
    Change of the score in the FOG-Q

    Full Information

    First Posted
    October 8, 2016
    Last Updated
    October 12, 2016
    Sponsor
    Beijing Pins Medical Co., Ltd
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02929628
    Brief Title
    Evaluate the Safety and Effectiveness of Various Frequency Stimulation for Patients With Parkinson's Disease
    Official Title
    Evaluate the Safety and Effectiveness Between Various Frequency Stimulation and Traditional High Frequency Stimulation for the Treatment of Patients With Parkinson's Disease
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2016
    Overall Recruitment Status
    Unknown status
    Study Start Date
    December 2016 (undefined)
    Primary Completion Date
    August 2017 (Anticipated)
    Study Completion Date
    November 2017 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Beijing Pins Medical Co., Ltd

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Parkinson's Disease

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    106 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Patients with Various Frequency Stimulation
    Arm Type
    Experimental
    Arm Description
    Patients are in the condition of Various Frequency Stimulation
    Arm Title
    Patients With Traditional Frequency Stimulation
    Arm Type
    Sham Comparator
    Arm Description
    Patients in the condition of Sham Comparator are Traditional Frequency Stimulation
    Intervention Type
    Device
    Intervention Name(s)
    Beijing PINS Programming
    Intervention Description
    Using the programming control the Stimulator to change the parameter
    Primary Outcome Measure Information:
    Title
    Changs in the score of Stand-Walk-Sit Test
    Time Frame
    1、3、6 and 12 month
    Secondary Outcome Measure Information:
    Title
    Change of the score in UPDRS
    Time Frame
    1,3,6,12 months of Various Frequency Stimulation
    Title
    Change of the score in PDQ-39
    Time Frame
    1、3、6、12 months of Various Frequency Stimulation
    Title
    Change of the score in the FOG-Q
    Time Frame
    1、3、6、12 month of Various Frequency Stimulation

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    85 Years
    Accepts Healthy Volunteers
    No
    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

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes

    Learn more about this trial

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

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