Automated Deep Brain Stimulation Programming Using Functional Mapping

N/AUnknownNCT02765282

Great Lakes NeuroTechnologies Inc.40 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

SINGLE

Enrollment

Conditions

Parkinson Disease

Interventions

Algorithm based programming using Kinesia-based assessmentDEVICE

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

Sex: ALLMin age: 35 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (3)

Atrium Health

Charlotte, North Carolina, United States

RECRUITING

Wake Forest University

Winston-Salem, North Carolina, United States

RECRUITING

Ohio State University

Columbus, Ohio, United States

RECRUITING

Outcomes

Primary Outcomes

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

Time frame: Up to 2 hours (from start of programming session until end of programming session)

Central Contacts

Dustin A Heldman, PhD

CONTACT

2163615410 dheldman@glneurotech.com

Data from ClinicalTrials.gov

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