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

Parkinson's Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02251808
• Other study ID #: PINS-001
• Status: Recruiting
• Phase: N/A
• First received: September 24, 2014
• Last updated: October 12, 2016
• Start date: September 2014
• Est. completion date: September 2024

Study information

• Verified date: May 2016
• Source: Beijing Pins Medical Co., Ltd
• Contact: Fumin Jia
• Phone: 010-60736388
• Email: pins_medical[@]163.con
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 612
• Est. completion date: September 2024
• Est. primary completion date: September 2024
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Locations

Country	Name	City	State
China	Beijing Tiantan Hospital	Beijing	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
Beijing Pins Medical Co., Ltd	Beijing Tiantan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient Satisfaction as Measured by Giving a Form By PINS Medical.	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.	3 months after DBS surgery	No