Automated Deep Brain Stimulation Programming Using Functional Mapping (DBS-Expert)

G

Great Lakes NeuroTechnologies

Status

Unknown

Conditions

Parkinson Disease

Treatments

Device: Algorithm based programming using Kinesia-based assessment

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT02765282
R44NS081902

Details and patient eligibility

About

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

Enrollment

40 estimated patients

Sex

All

Ages

35 to 80 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Health Services Research

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Single Blind

40 participants in 2 patient groups

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

Trial contacts and locations

3

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Central trial contact

Dustin A Heldman, PhD

Data sourced from clinicaltrials.gov

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