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

Primary Purpose

Parkinson Disease

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Algorithm based programming using Kinesia-based assessment
Sponsored by
Great Lakes NeuroTechnologies Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Parkinson Disease focused on measuring Deep brain stimulation (DBS), Kinesia

Eligibility Criteria

35 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Atrium HealthRecruiting
  • Wake Forest UniversityRecruiting
  • Ohio State UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

DBS-Expert Programming First

Traditional Programming First

Arm Description

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.

These patients will be programmed by a clinician first and then undergo algorithm based programming using Kinesia-based assessment (DBS-Expert) within five days.

Outcomes

Primary Outcome Measures

Programming time when programmed using Kinesia-based assessment (DBS-Expert) compared to programming time when programmed by a clinician
Amount of time it took to arrive at DBS settings that provide sufficient therapeutic benefit will be compared across programming sessions

Secondary Outcome Measures

Full Information

First Posted
April 27, 2016
Last Updated
June 25, 2019
Sponsor
Great Lakes NeuroTechnologies Inc.
Collaborators
Wake Forest University Health Sciences, Ohio State University, Wake Forest University
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1. Study Identification

Unique Protocol Identification Number
NCT02765282
Brief Title
Automated Deep Brain Stimulation Programming Using Functional Mapping
Acronym
DBS-Expert
Official Title
Automated Deep Brain Stimulation Programming Using Functional Mapping
Study Type
Interventional

2. Study Status

Record Verification Date
June 2019
Overall Recruitment Status
Unknown status
Study Start Date
October 1, 2018 (Actual)
Primary Completion Date
June 2020 (Anticipated)
Study Completion Date
June 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Great Lakes NeuroTechnologies Inc.
Collaborators
Wake Forest University Health Sciences, Ohio State University, Wake Forest University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
Participants will undergo DBS programming guided by the DBS-Expert system and by a clinician per standard care.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
Keywords
Deep brain stimulation (DBS), Kinesia

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
DBS-Expert Programming First
Arm Type
Experimental
Arm Description
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.
Arm Title
Traditional Programming First
Arm Type
Experimental
Arm Description
These patients will be programmed by a clinician first and then undergo algorithm based programming using Kinesia-based assessment (DBS-Expert) within five days.
Intervention Type
Device
Intervention Name(s)
Algorithm based programming using Kinesia-based assessment
Other Intervention Name(s)
DBS-Expert
Intervention Description
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.
Primary Outcome Measure Information:
Title
Programming time when programmed using Kinesia-based assessment (DBS-Expert) compared to programming time when programmed by a clinician
Description
Amount of time it took to arrive at DBS settings that provide sufficient therapeutic benefit will be compared across programming sessions
Time Frame
Up to 2 hours (from start of programming session until end of programming session)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dustin A Heldman, PhD
Phone
2163615410
Email
dheldman@glneurotech.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dustin A Heldman, PhD
Organizational Affiliation
Great Lakes NeuroTechnologies Inc.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Atrium Health
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28207
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jennifer Mabry, MT (ASCP)
Phone
704-446-1982
Email
Jennifer.Mabry@atriumhealth.org
First Name & Middle Initial & Last Name & Degree
Danielle Englert, MD
Facility Name
Wake Forest University
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jessica Dimos
Phone
336-716-8694
Email
jdimos@wakehealth.edu
First Name & Middle Initial & Last Name & Degree
Ihtsham Haq, MD
Facility Name
Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amanda Luff, MPH, CCRP
Phone
614-293-2443
Email
Amanda.Luff@osumc.edu
First Name & Middle Initial & Last Name & Degree
Vibhor Krishna, MBBS

12. IPD Sharing Statement

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Automated Deep Brain Stimulation Programming Using Functional Mapping

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