Recruiting

Deep Brain Stimulation

Sponsor:

Great Lakes NeuroTechnologies Inc.

Code:

NCT02765282

Conditions

Parkinson Disease

Eligibility Criteria

Sex: All

Age: 35 - 70+

Healthy Volunteers: Not accepted

Interventions

Algorithm based programming using Kinesia-based assessment

Study Details

Brief summary:

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

Conditions

Parkinson Disease

Study ID

NCT02765282

Start date

Oct 1, 2018

Status verified date

Jun, 2019

Completion date

Jun, 2020

Anticipated

Primary completion date

Jun, 2020

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 35 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

experimental: DBS-Expert Programming First

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.

experimental: Traditional Programming First

These patients will be programmed by a clinician first and then undergo algorithm based programming using Kinesia-based assessment (DBS-Expert) within five days.

Interventions

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.

Primary outcome measure

  • Programming time when programmed using Kinesia-based assessment (DBS-Expert) compared to programming time when programmed by a clinician [ Time Frame: Up to 2 hours (from start of programming session until end of programming session) ]

Central Contacts and Locations

Central contacts

Dustin A Heldman, PhD

2163615410dheldman@glneurotech.com

Locations

Atrium Health

Recruiting

Charlotte, North Carolina, United States, 28207

Contacts

Jennifer Mabry, MT (ASCP)

704-446-1982Jennifer.Mabry@atriumhealth.org

Principal Investigator:

Danielle Englert, MD

Wake Forest University

Recruiting

Winston-Salem, North Carolina, United States, 27157

Contacts

Jessica Dimos

336-716-8694jdimos@wakehealth.edu

Principal Investigator:

Ihtsham Haq, MD

Ohio State University

Recruiting

Columbus, Ohio, United States, 43210

Contacts

Amanda Luff, MPH, CCRP

614-293-2443Amanda.Luff@osumc.edu

Principal Investigator:

Vibhor Krishna, MBBS

More Information

Sponsor

Great Lakes NeuroTechnologies Inc.

Last update posted

Jun 27, 2019

Last verified

Jun, 2019

Keywords

  • Deep brain stimulation (DBS)
  • Kinesia

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Great Lakes NeuroTechnologies Inc. on 2019-06-27.