Parkinson Disease
Conditions
Keywords
Deep brain stimulation (DBS), Kinesia
Brief summary
Participants will undergo DBS programming guided by the DBS-Expert system and by a clinician per standard care.
Interventions
DEVICEAlgorithm 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.
Sponsors
Wake Forest University Health Sciences
Ohio State University
Wake Forest University
Great Lakes NeuroTechnologies Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
35 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Programming time when programmed using Kinesia-based assessment (DBS-Expert) compared to programming time when programmed by a clinician | 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 |
Countries
United States
Contacts
Primary ContactDustin A Heldman, PhD
Outcome results
None listed