Evaluate the Safety and Effectiveness Between Various Frequency Stimulation and Traditional High Frequency Stimulation for the Treatment of Patients With Parkinson's Disease
Trial Snapshot
- Phase
- Phase 2
- Enrollment
- 106
- Primary Endpoint
- Changs in the score of Stand-Walk-Sit Test
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •Pregnant female
- •History of severe neuropsychiatric disease
- •Patients are taking part in other clinical trials in recent several months
Arms & Interventions
Patients with Various Frequency Stimulation
Patients are in the condition of Various Frequency Stimulation
Intervention: Beijing PINS Programming (Device)
Patients With Traditional Frequency Stimulation
Patients in the condition of Sham Comparator are Traditional Frequency Stimulation
Intervention: Beijing PINS Programming (Device)
Outcomes
Primary Outcomes
Changs in the score of Stand-Walk-Sit Test
Time Frame: 1、3、6 and 12 month
Secondary Outcomes
- 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)