The Safety of Remote DBS Programming System

March 22, 2018 updated by: Bomin Sun, Ruijin Hospital

A Pilot Study to Investigating Safety of A Remote and Wireless Deep Brain Stimulation Programming System for Parkinson's Disease

Remote programming has significant advantages over conventional programming methods on some issues. This research will test the safety of SceneRay remote and wireless DBS programming system.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

Programming is a crucial aspect of deep brain stimulation (DBS), directly influences the final success of DBS. Optimal programming helps patients achieve maximized control of clinical symptoms and higher life quality. However, there are a number of inadequacies in conventional programming methods. First, the programming probe must come into close contact with the implantable pulse generator (IPG) and test stimulator to complete programming. And during initial postoperative programming, only the parameters of one patient can be ascertained. In addition, the same frequency is typically used in the left and right brain for dual channel IPG. The patient also need to repeatedly travel between their home and the hospital, leading to increased time and expense. Therefore, the investigators developed the SceneRay wireless and remote DBS system to address the outline issues. This system has significant advantages over conventional programming methods on all the issues above. This research will test the safety of this remote and wireless DBS programming system.

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

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

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200025
        • Shanghai Ruijin Hospital Functional Neurosurgery

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 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Primary PD patients volunteered to receive DBS surgery with SceneRay wireless and remote DBS system,
  • Age 18-75 years,
  • Achieved optimal control of clinical symptoms after coventional programming for 3-12 months,
  • Significant difference in motor function when DBS is switched on/off,
  • Good compliance and easy to follow-up,

Exclusion Criteria:

  • No significant improvement or clinical efficacy in symptoms after surgery,
  • Severe cognitive impairment due to dementia (Mini-Mental State Examination score: illiteracy <17, elementary school <20, junior high school or above <24) or inability to accurately record in a diary,
  • Active psychosis or a history of psychosis,
  • Serious heart, liver, or kidney diseases,
  • Severe hypertension or orthostatic hypotension, severe diabetes, or diabetes accompanied by brain and cardiovascular diseases,
  • Malignant cancer, brain injuries, epilepsy, or other unstable medical conditions,
  • Severe alcohol dependence or drug abuse,
  • Any situation that may jeopardize the patient's safety or lead to a failure to participate in the study (medical, psychological, social, or georational factors) at present or in the future,
  • Participating in other clinical trials,
  • Other factors that researchers think may not be suitable for research.

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

  • Primary Purpose: Device Feasibility
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: remote programming system
Device: SceneRay wireless and remote DBS system
Implement therapeutic programming in patients with network coverage at home

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Unified Parkinson's Disease Rating Scale III&IV
Time Frame: Through study completion, an average of 4 months
Through study completion, an average of 4 months
Deep Brain Stimulation Programming parameter
Time Frame: Through study completion, an average of 4 months
Contact selection
Through study completion, an average of 4 months
Deep Brain Stimulation Programming parameter
Time Frame: Through study completion, an average of 4 months
Pulse width
Through study completion, an average of 4 months
Deep Brain Stimulation Programming parameter
Time Frame: Through study completion, an average of 4 months
Frequency
Through study completion, an average of 4 months
Deep Brain Stimulation Programming parameter
Time Frame: Through study completion, an average of 4 months
Amplitude
Through study completion, an average of 4 months
Serious Adverse Event
Time Frame: Through study completion, an average of 4 months
Through study completion, an average of 4 months

Collaborators and Investigators

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

Sponsor

Ruijin Hospital

Investigators

  • Principal Investigator: Zhang Chencheng, MD, Ruijin Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

August 8, 2017

Primary Completion (Anticipated)

March 1, 2018

Study Completion (Anticipated)

March 1, 2018

Study Registration Dates

First Submitted

August 23, 2017

First Submitted That Met QC Criteria

August 28, 2017

First Posted (Actual)

August 30, 2017

Study Record Updates

Last Update Posted (Actual)

March 26, 2018

Last Update Submitted That Met QC Criteria

March 22, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DBS telemedicine

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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