Automated Deep Brain Stimulation Programming Using Functional Mapping

Not Applicable

• Conditions: Parkinson Disease
• Interventions: Device: Algorithm based programming using Kinesia-based assessment

• Registration Number: NCT02765282
• Lead Sponsor: Great Lakes NeuroTechnologies Inc.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-04-27
• Study First Submitted QC: 2016-05-04
• Study First Posted: 2016-05-06
• Study Start: 2018-10-01
• Status Verified: 2019-06
• Last Update Submitted: 2019-06-25
• Last Update Posted: 2019-06-27
• Primary Completion: 2020-06
• Study Completion: 2020-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Traditional Programming First	Algorithm based programming using Kinesia-based assessment	These patients will be programmed by a clinician first and then undergo algorithm based programming using Kinesia-based assessment (DBS-Expert) within five days.
DBS-Expert Programming First	Algorithm based programming using Kinesia-based assessment	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.

Primary Outcome Measures

Name	Time	Method
Programming time when programmed using Kinesia-based assessment (DBS-Expert) compared to programming time when programmed by a clinician	Up to 2 hours (from start of programming session until end of programming session)	Amount of time it took to arrive at DBS settings that provide sufficient therapeutic benefit will be compared across programming sessions

Trial Locations

Locations (3)

Atrium Health; 🇺🇸 Charlotte, North Carolina, United States

Wake Forest University; 🇺🇸 Winston-Salem, North Carolina, United States

Ohio State University; 🇺🇸 Columbus, Ohio, United States