Pilot Study for Automated Deep Brain Stimulation Programming

Great Lakes NeuroTechnologies

Status: Completed

Conditions: Tremor; Bradykinesia; Parkinson's Disease

Treatments: Device: Automated Programming

Study type: Interventional

Funder types: Other; Industry; NIH

Identifiers

NCT02046863

1R43NS081902-01

1R43NS081902 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

The clinical utility of deep brain stimulation (DBS) for the treatment of movement disorders such as Parkinson's disease has been well established; however, there is a great disparity in outcomes among DBS recipients due to varied postoperative management, particularly concerning the choosing of an optimal set of programming parameters from the thousands of possible combinations. This study will evaluate the use of motion sensor based assessments to develop a functional map and algorithms to automatically determine a set of programming parameters that maximize symptomatic benefits while minimizing side effects and battery consumption.

Enrollment: 7 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Clinical diagnosis of idiopathic Parkinson's disease
• Implanted deep brain stimulation system awaiting initial programming session

Exclusion criteria

• Subjects with significant psychiatric illness or dementia
• Significant cognitive impairment

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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7 participants in 1 patient group

Automated Programming

Experimental group

Description:

Subjects will have DBS settings changed as guided by prototype DBS-Expert software. Tremor, bradykinesia, and dyskinesia will be assessed at each DBS setting.

Treatment:

Device: Automated Programming