Pilot Study for Automated Deep Brain Stimulation Programming

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.

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Key information

Conditions

Parkinson's Disease Basal Ganglia Diseases Bradykinesia Brain Diseases Central Nervous System Diseases Dyskinesias Hypokinesia Movement Disorders Nervous System Diseases Neurodegenerative Diseases Neurologic Manifestations Parkinson Disease Parkinsonian Disorders Pathological Conditions, Signs and Symptoms Signs and Symptoms Synucleinopathies Tremor

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Cincinnati Department of Neurology

Cincinnati, Ohio, 45267, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Automated Programming

Device

Prototype DBS-Expert software will be used to guide a clinician through DBS programming.

Primary outcomes

Percent Change From Baseline in Kinesia HomeView Symptom Ratings After Guided DBS Programming

Time frame: Within two days of standard clinical DBS programming session

Symptoms were first assessed with the implanted pulse generator (IPG) turned off for at least 30 minutes to allow the after-effects of stimulation to wear off (baseline). Symptoms were measured again with the IPG turned on at a setting that both minimized the average severity of tremor and bradykinesia and minimized side effects. The Kinesia score rated symptom severity (0, normal; 4, most severe) in four categories: tremor, finger tapping speed, finger tapping amplitude, and finger tapping rhythm. Scores for the four motor symptoms were averaged and converted to percent change from baseline.

Sponsors and collaborators

Lead sponsor

Great Lakes NeuroTechnologies Inc.

Industry

Collaborators

National Institute of Neurological Disorders and Stroke (NINDS)
University of Cincinnati

Registry information

Official study title

DBS-Expert: Automated Deep Brain Stimulation Programming Using Functional Mapping - Phase I

Important dates

Study start: 2013
Primary completion: 2014
Study completion: 2014
First posted: Jan 28, 2014
Registry last updated: Sep 22, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed