Satisfaction Survey on PINS Stimulator System for Patients With Parkinson's Disease

Beijing Pins Medical

Status: Enrolling

Conditions: Parkinson's Disease

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT02251808

PINS-001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 612 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.