The objective is to design, build, and clinically assess ParkinTune"""""""", an advanced wireless movement disorder monitor technology to augment stimulation programming (tuning) involved in deep brain stimulation (DBS) procedures for Parkinson's Disease (PD). Major PD symptoms that affect quality of life include tremor, bradykinesia, and rigidity. While the exact mechanism that fuels DBS clinical success stories remains unclear, the procedure has been shown to effectively relieve PD motor symptoms when medication is no longer effective. However, clinicians lack tools that combine physiological, electrical, and behavioral data to optimize electrode placement and stimulator programming. Optimizing electrode placement and stimulator parameters improves the amount of motor symptom reduction patients receive and minimizes complications. The current standard in evaluating symptoms is the Unified Parkinson's Disease Rating Scale (UPDRS), a qualitative ranking system. A battery of exercises, typically a subset of the upper extremity motor section of the UPDRS, is normally completed during DBS electrode placement surgery and subsequent programming sessions to evaluate performance while a clinician qualitatively assesses symptoms. CleveMed has previously developed a compact wireless system to quantify movement disorder symptoms called ParkinSense"""""""". This previously existing technology will serve as the hardware platform for this proposed program. While previous work has shown excellent results to objectively quantify symptoms during a clinical exam, this proposed project will integrate several new features for real-time assistance with DBS surgery electrode placement and stimulation programming. The clinically deployable ParkinTune system resulting from this proposed Fast-Track application will provide a compact wireless system for use in the operating room and outpatient follow up programming sessions that maximizes patient safety and comfort. The objective biokinetic data transmitted during electrode placement and subsequent programming will be input to algorithms that output a continuous scale of objective PD symptom severity in real-time to guide clinician decision making. The improved resolution and repeatable results of the ParkinTune system should reduce time and costs of DBS procedures as well as optimize patient outcomes.

Public Health Relevance

While the exact mechanism that fuels deep brain stimulation clinical success stories remains unclear, the procedure effectively relieves Parkinson's disease motor symptoms when medication is no longer effective. However, clinicians lack tools that combine physiological, electrical, and behavioral data to optimize electrode placement and stimulator programming. ParkinTune, a repeatable, automated tool that can quantify motor symptoms will assist stimulation programming during surgical electrode placement and outpatient follow up to optimize patient outcomes and reduce associated time and costs.

Agency
National Institute of Health (NIH)
Institute
National Institute on Aging (NIA)
Type
Small Business Innovation Research Grants (SBIR) - Phase II (R44)
Project #
3R44AG033520-02S1
Application #
7934369
Study Section
Special Emphasis Panel (ZRG1-MOSS-F (15))
Program Officer
Chen, Wen G
Project Start
2009-09-30
Project End
2011-08-31
Budget Start
2009-09-30
Budget End
2011-08-31
Support Year
2
Fiscal Year
2009
Total Cost
$139,411
Indirect Cost
Name
Cleveland Medical Devices, Inc.
Department
Type
DUNS #
557510625
City
Cleveland
State
OH
Country
United States
Zip Code
44103
Pulliam, Christopher L; Heldman, Dustin A; Orcutt, Tseganesh H et al. (2015) Motion sensor strategies for automated optimization of deep brain stimulation in Parkinson's disease. Parkinsonism Relat Disord 21:378-82
Mera, Thomas; Vitek, Jerrold L; Alberts, Jay L et al. (2011) Kinematic optimization of deep brain stimulation across multiple motor symptoms in Parkinson's disease. J Neurosci Methods 198:280-6