Automated Deep Brain Stimulation Programming Using Functional Mapping (DBS-Expert)

June 25, 2019 updated by: Great Lakes NeuroTechnologies Inc.
Participants will undergo DBS programming guided by the DBS-Expert system and by a clinician per standard care.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

40

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 Contact

Study Locations

  • United States
    • North Carolina
      • Charlotte, North Carolina, United States, 28207
        • Recruiting
        • Atrium Health
        • Contact:
        • Principal Investigator:
          • Danielle Englert, MD
      • Winston-Salem, North Carolina, United States, 27157
        • Recruiting
        • Wake Forest University
        • Contact:
    • Ohio
      • Columbus, Ohio, United States, 43210
        • Recruiting
        • Ohio State University
        • Contact:
        • Principal Investigator:
          • Vibhor Krishna, MBBS

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

35 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • The ability to provide informed consent
  • Clinical diagnosis of idiopathic Parkinson's disease (PD)
  • Implanted deep brain stimulation (DBS) system for tremor and/or bradykinesia

Exclusion Criteria:

  • Significant medical or psychiatric illness or dementia as evidenced by a score less than 26 on the Montreal Cognitive Assessment
  • Not capable of functioning independently
  • Individuals so symptomatic as to compromise safety

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: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: DBS-Expert Programming First
These patients will be undergo algorithm based programming using Kinesia-based assessment (DBS-Expert) first and then be programmed by a clinician within five days.
Device: Algorithm based programming using Kinesia-based assessment
DBS-Expert includes a tablet-based software application (app) for guiding DBS programming and a Kinesia motion sensor unit for automated motor assessment. Algorithms search the programming parameter space to resolve an optimal set of programming parameters.
Other Names:
  • DBS-Expert
Experimental: Traditional Programming First
These patients will be programmed by a clinician first and then undergo algorithm based programming using Kinesia-based assessment (DBS-Expert) within five days.
Device: Algorithm based programming using Kinesia-based assessment
DBS-Expert includes a tablet-based software application (app) for guiding DBS programming and a Kinesia motion sensor unit for automated motor assessment. Algorithms search the programming parameter space to resolve an optimal set of programming parameters.
Other Names:
  • DBS-Expert

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Programming time when programmed using Kinesia-based assessment (DBS-Expert) compared to programming time when programmed by a clinician
Time Frame: Up to 2 hours (from start of programming session until end of programming session)
Amount of time it took to arrive at DBS settings that provide sufficient therapeutic benefit will be compared across programming sessions
Up to 2 hours (from start of programming session until end of programming session)

Collaborators and Investigators

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

Sponsor

Great Lakes NeuroTechnologies Inc.

Collaborators

Wake Forest University Health Sciences
Ohio State University
Wake Forest University

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)

October 1, 2018

Primary Completion (Anticipated)

June 1, 2020

Study Completion (Anticipated)

June 1, 2020

Study Registration Dates

First Submitted

April 27, 2016

First Submitted That Met QC Criteria

May 4, 2016

First Posted (Estimate)

May 6, 2016

Study Record Updates

Last Update Posted (Actual)

June 27, 2019

Last Update Submitted That Met QC Criteria

June 25, 2019

Last Verified

June 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R44NS081902 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

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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