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

  • STATUS
    Recruiting
  • participants needed
    612
  • sponsor
    Beijing Pins Medical Co., Ltd
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Updated on 19 February 2024
See if I qualify
brain stimulation
parkinson's disease

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.

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.

Details
Condition Parkinson's Disease, Parkinson's Disease
Age 18years - 80years
Clinical Study IdentifierNCT02251808
SponsorBeijing Pins Medical Co., Ltd
Last Modified on19 February 2024

Eligibility

 Yes No Not Sure

Inclusion Criteria

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 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
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