Clinical trial NCT02251808: Satisfaction Survey on PINS Stimulator System for Patients With Parkinson's Disease
Official title: Satisfaction Survey on PINS Stimulator System for Patients With Parkinson's Disease
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Parkinson's Disease
Keywords: Parkinson's Disease, Deep brain stimulation
Lead sponsor: Beijing Pins Medical Co., Ltd
Sponsor class: INDUSTRY
Collaborators: name: Beijing Tiantan Hospital
First posted: 2014-09-29
Enrollment: 612
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Patient Satisfaction as Measured by Giving a Form By PINS Medical.
timeFrame: 3 months after DBS surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Tiantan Hospital
state: Beijing
Study officials:
affiliation: study principal investigator
name: Jianguo Zhang, MD
role: STUDY_DIRECTOR
References: