Parkinson's Disease
Conditions
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.
Interventions
DEVICEBeijing PINS Programming
Using the programming control the Stimulator to change the parameter
Sponsors
Beijing Pins Medical Co., Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
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 * epilepsy * Pregnant female * History of severe neuropsychiatric disease * Patients are taking part in other clinical trials in recent several months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changs in the score of Stand-Walk-Sit Test | 1、3、6 and 12 month |
Secondary
| Measure | Time frame |
|---|---|
| Change of the score in UPDRS | 1,3,6,12 months of Various Frequency Stimulation |
| 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 |
Outcome results
None listed