Parkinson's Disease
Conditions
Keywords
Parkinson's Disease, Deep brain stimulation
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-rechargeable Deep Brain Stimulation (at baseline visit and at follow-up visit) and by evaluating their responses to the product satisfaction survey that will be given to them by a study coordinator.
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 Stimulator System.
Interventions
None listed
Sponsors
Beijing Tiantan Hospital
Beijing Pins Medical Co., Ltd
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Subject is 18 to 80 years of age. 2. Subject has been diagnosed, by a neurologist, with idiopathic Parkinson's disease. 3. The PD patients can recharge the neurostimulator independently, with favourable compliance and commit to cooperate with the clinical trial study, 4. Subjects are PINS neurostimulator users
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient Satisfaction as Measured by Giving a Form By PINS Medical. | 3 months after DBS surgery | Of 612 patients implanted with the rechargeable IPGs and non-rechargeable (including 306 PD received rechargeable IPGs, 306 PD received non-rechargeable IPGs) were followed before and 3 months after DBS surgery and completed a systematic survey of satisfaction with PINS Stimulator System. |
Countries
China
Contacts
Primary ContactFumin Jia
Backup ContactLuming Li
Outcome results
None listed