Automated Deep Brain Stimulation Programming Using Functional Mapping

Parkinson Disease Clinical Trial

— DBS-Expert  

Official title:

Automated Deep Brain Stimulation Programming Using Functional Mapping

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02765282
• Other study ID #: R44NS081902
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2018
• Est. completion date: June 2020

Study information

• Verified date: June 2019
• Source: Great Lakes NeuroTechnologies Inc.
• Contact: Dustin A Heldman, PhD
• Phone: 2163615410
• Email: dheldman[@]glneurotech.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: June 2020
• Est. primary completion date: June 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

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.

Locations

Country	Name	City	State
United States	Atrium Health	Charlotte	North Carolina
United States	Ohio State University	Columbus	Ohio
United States	Wake Forest University	Winston-Salem	North Carolina

Sponsors (4)

Lead Sponsor	Collaborator
Great Lakes NeuroTechnologies Inc.	Atrium Health, Ohio State University, Wake Forest University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)