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

October 12, 2016 updated by: Beijing Pins Medical Co., Ltd
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.

Study Overview

Status

Recruiting

Conditions

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.

Study Type

Observational

Enrollment (Anticipated)

612

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Luming Li
  • Phone Number: 010-59361265

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100050
        • Recruiting
        • Beijing Tiantan hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient Satisfaction as Measured by Giving a Form By PINS Medical.
Time Frame: 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.
3 months after DBS surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beijing Pins Medical Co., Ltd

Collaborators

Beijing Tiantan Hospital

Investigators

  • Study Director: Jianguo Zhang, MD, Study Principal Investigator

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2014

Primary Completion (Anticipated)

September 1, 2024

Study Completion (Anticipated)

September 1, 2024

Study Registration Dates

First Submitted

September 24, 2014

First Submitted That Met QC Criteria

September 25, 2014

First Posted (Estimate)

September 29, 2014

Study Record Updates

Last Update Posted (Estimate)

October 13, 2016

Last Update Submitted That Met QC Criteria

October 12, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PINS-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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