Status:
UNKNOWN
Satisfaction Survey on PINS Stimulator System for Patients With Parkinson's Disease
Lead Sponsor:
Beijing Pins Medical Co., Ltd
Collaborating Sponsors:
Beijing Tiantan Hospital
Conditions:
Parkinson's Disease
Eligibility:
All Genders
18-80 years
Brief Summary
This study will be done because the investigators would like to evaluate product satisfaction of two PINS products (product A, product B) that are to evaluate the effectiveness of rechargeable and non...
Detailed Description
Other: IPGs products Patients implanted with the rechargeable IPGs and non-rechargeable were followed before and 3 months after DBS surgery and completed a systematic survey of satisfaction with PINS ...
Eligibility Criteria
Inclusion
- Subject is 18 to 80 years of age.
- Subject has been diagnosed, by a neurologist, with idiopathic Parkinson's disease.
- The PD patients can recharge the neurostimulator independently, with favourable compliance and commit to cooperate with the clinical trial study,
- Subjects are PINS neurostimulator users
Exclusion
- Subject were major depression with suicidal thoughts (a score of \>25 on the Beck Depression Inventory II,20 with scoresranging from 0 to 63 and higher scores indicating worse functioning), tumor, abnormality in routine liver and renal function, cerebral infarction, hydrocephalus, encephalatrophy, stroke sequela, heart disease, thrombocytopenia, hyperthermalgesia and any medical or psychological problem that would interfere with the conduction of the study protocol.Patients with symptoms of the midline at the state of off medication such as severe language barrier, dysphagia, disequilibrium, slipping-clutch gaitwere excluded. Patients who had undergone other implantation such as cardiac pacemaker, artificial cochlea because of the accompanied diseases such as were excluded. Patients with history of pallidotomy, stereotactic radiofrequency (Gamma Knife) and cell transplantation were also excluded.
Key Trial Info
Start Date :
September 1 2014
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
September 1 2024
Estimated Enrollment :
612 Patients enrolled
Trial Details
Trial ID
NCT02251808
Start Date
September 1 2014
End Date
September 1 2024
Last Update
October 13 2016
Active Locations (1)
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1
Beijing Tiantan Hospital
Beijing, Beijing Municipality, China, 100050