Automated Deep Brain Stimulation Programming Using Functional Mapping
DBS-Expert
1 other identifier
interventional
40
1 country
3
Brief Summary
Participants will undergo DBS programming guided by the DBS-Expert system and by a clinician per standard care.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable parkinson-disease
Started Oct 2018
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 27, 2016
CompletedFirst Posted
Study publicly available on registry
May 6, 2016
CompletedStudy Start
First participant enrolled
October 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2020
CompletedJune 27, 2019
June 1, 2019
1.7 years
April 27, 2016
June 25, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Up to 2 hours (from start of programming session until end of programming session)
Study Arms (2)
DBS-Expert Programming First
EXPERIMENTALThese patients will be undergo algorithm based programming using Kinesia-based assessment (DBS-Expert) first and then be programmed by a clinician within five days.
Traditional Programming First
EXPERIMENTALThese patients will be programmed by a clinician first and then undergo algorithm based programming using Kinesia-based assessment (DBS-Expert) within five days.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Great Lakes NeuroTechnologies Inc.lead
- Wake Forest University Health Sciencescollaborator
- Ohio State Universitycollaborator
- Wake Forest Universitycollaborator
Study Sites (3)
Atrium Health
Charlotte, North Carolina, 28207, United States
Wake Forest University
Winston-Salem, North Carolina, 27157, United States
Ohio State University
Columbus, Ohio, 43210, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Dustin A Heldman, PhD
Great Lakes NeuroTechnologies Inc.
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 27, 2016
First Posted
May 6, 2016
Study Start
October 1, 2018
Primary Completion
June 1, 2020
Study Completion
June 1, 2020
Last Updated
June 27, 2019
Record last verified: 2019-06