- Award Details
ParkinTune: Automated PD Motor Symptom Assessment for DBS Programming
Department of Health and Human Services
Agency Tracking Number:
Solicitation Topic Code:
Small Business Information
CLEVELAND MEDICAL DEVICES, INC.
4415 EUCLID AVE, CLEVELAND, OH, 44103
Socially and Economically Disadvantaged:
Name: JOSEPH GIUFFRIDA
Phone: (216) 619-5904
Phone: (216) 619-5904
Phone: (216) 791-6720
AbstractDESCRIPTION (provided by applicant): 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) proce dures 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 rel ieve 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 stimula tor 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 exer cises, 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. CleveMe d 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 resu lts 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 re sulting 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 sy stem 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 Par kinson'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, automa ted 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.
* information listed above is at the time of submission.