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

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

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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