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ParkinTune: Automated PD Motor Symptom Assessment for DBS Programming

Award Information

Agency:
Department of Health and Human Services 		Branch:
N/A 		Award ID:
88677 		Program Year/Program:
2009 / SBIR
Agency Tracking Number:
AG033520 		Solicitation Year:
N/A 		Solicitation Topic Code:
N/A 		Solicitation Number:
N/A
Small Business Information
CLEVELAND MEDICAL DEVICES, INC.
4415 EUCLID AVE CLEVELAND, OH -
View profile »
Woman-Owned: No
Minority-Owned: No
HUBZone-Owned: No
 
Phase 2
Fiscal Year: 2009
Title: ParkinTune: Automated PD Motor Symptom Assessment for DBS Programming
Agency: HHS
Contract: 4R44AG033520-02
Award Amount: $992,570.00
 

Abstract:

DESCRIPTION (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.

Principal Investigator:

Joseph P. Giuffrida
2166195904
JGIUFFRIDA@CLEVEMED.COM

Business Contact:

Hani Kayyali
hkayyali@clevemed.com
Small Business Information at Submission:

CLEVELAND MEDICAL DEVICES, INC.
4415 EUCLID AVE CLEVELAND, OH 44103

EIN/Tax ID: 341675639
DUNS: N/A
Number of Employees: N/A
Woman-Owned: No
Minority-Owned: No
HUBZone-Owned: No