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Automated Deep Brain Stimulation Programming Using Functional Mapping

NCT02765282 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2019-06-27

No results posted yet for this study

Summary

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

Conditions

  • Parkinson Disease

Interventions

DEVICE

Algorithm 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 & Collaborators

  • Wake Forest University Health Sciences

    collaborator OTHER

  • Ohio State University

    collaborator OTHER

  • Wake Forest University

    collaborator OTHER

  • Great Lakes NeuroTechnologies Inc.

    lead INDUSTRY

Principal Investigators

  • Dustin A Heldman, PhD · Great Lakes NeuroTechnologies Inc.

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
35 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-10-01
Primary Completion
2020-06-30
Completion
2020-06-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02765282 on ClinicalTrials.gov