Evaluate the Safety and Effectiveness of Various Frequency Stimulation for Patients With Parkinson's Disease
Phase 2
- Conditions
- Parkinson's Disease
- Registration Number
- NCT02929628
- Lead Sponsor
- Beijing Pins Medical Co., Ltd
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 106
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Changs in the score of Stand-Walk-Sit Test 1、3、6 and 12 month
- Secondary Outcome Measures
Name Time Method 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 Change of the score in UPDRS 1,3,6,12 months of Various Frequency Stimulation