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
About this trial
This is an interventional treatment trial for Parkinson's Disease
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
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
NCT ID
NCT02929628
First Posted
October 8, 2016
Last Updated
October 12, 2016
Sponsor
Beijing Pins Medical Co., Ltd
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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