Automated Deep Brain Stimulation Programming Using Functional Mapping

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

Official Title
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Automated Deep Brain Stimulation Programming Using Functional Mapping

Conditions
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Parkinson Disease

Intervention / Treatment
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* Device: Algorithm based programming using Kinesia-based assessment


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DBS-Expert Programming First<br>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<br>* 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.<br>* Other names: DBS-Expert;|
| Experimental: Traditional Programming First<br>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<br>* 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.<br>* Other names: DBS-Expert;|

What is the study measuring?
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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 | 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Deep brain stimulation (DBS), Kinesia