PDRemote: Automated Telehealth Diagnostics for Remote Parkinson's Monitoring

Award Information
Agency:
Department of Health and Human Services
Branch
n/a
Amount:
$399,068.00
Award Year:
2009
Program:
SBIR
Phase:
Phase I
Contract:
1R43MD004049-01
Agency Tracking Number:
MD004049
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, 44103
Hubzone Owned:
N
Minority Owned:
N
Woman Owned:
N
Duns:
557510625
Principal Investigator:
JOSEPH GIUFFRIDA
(216) 619-5904
JGIUFFRIDA@CLEVEMED.COM
Business Contact:
JOSEPH GIUFFRIDA
() -
hkayyali@clevemed.com
Research Institution:
n/a
Abstract
DESCRIPTION (provided by applicant): The objective is to design, build, and clinically assess a system for automated telehealth diagnostics for remote Parkinson's disease (PD) monitoring. Currently in the United States, there are approximately 1 million pa tients living with PD and 50,000 new cases reported each year. However, there is limited access to movement disorder specialist centers for a significant portion of this population (Fig 2) as well as limited opportunity for remote continuous monitoring of motor symptoms to capture complex fluctuation patterns and optimize treatment protocols. The proposed PDRemote system will integrate an existing advanced wireless movement disorder monitoring technology with a new infrastructure to remotely monitor PD pat ient symptoms. A repeatable, automated tool to more continuously monitor PD motor symptoms at home and remotely transmit severity reports to a clinician should improve outcomes and decrease costs for disparate patient populations not in close proximity to movement disorder specialists. Major PD symptoms include tremor, bradykinesia, and rigidity. Additionally, dyskinesias or wild involuntary movements as a side effect of drug therapy can be a motor complication. The current standard in evaluating symptoms i s the Unified Parkinson's Disease Rating Scale (UPDRS), a qualitative ranking system. The UPDRS motor section includes several movements the patient completes to elicit motor symptoms while a clinician qualitatively assesses the symptoms with a 0 - 4 score . It is normally completed during an office visit to obtain a snapshot of motor symptom severity. Clinicians currently lack effective, affordable technologies that can be easily delivered to PD patients for monitoring symptoms on a more continuous basis as symptoms typically fluctuate during the day as a function of treatment parameters. CleveMed previously developed a compact wireless system to quantify movement disorder symptoms called Kinesia . This previously existing technology will serve as the hardwa re platform for this proposed program. With only minor hardware upgrades required to fit PDRemote and excellent clinical results to date, this existing base enhances likelihood of project success. While previous work has shown excellent results to objectiv ely quantify symptoms during an in clinic exam, this proposed project will integrate several new features to translate this technology from the clinic to a patient's home. This will provide a clinically deployable evaluation tool that doctors can remotely order and then receive reports detailing a patient's PD symptom severity. The clinical technology resulting from this development will allow PD motor symptoms to be remotely monitored by clinicians on a more continuous basis. This should reduce costs and i mprove clinical outcomes by providing greater time resolution of symptom fluctuations and improving access to symptom monitoring for disparate populations in remote locations. PUBLIC HEALTH RELEVANCE: Parkinson's disease is primarily characterized b y motor symptoms of tremor, bradykinesia (slowed movements), and rigidity which can be very debilitating, leading to decreased mobility, independence, and quality of life. Clinicians lack quantitative tools for more continuous monitoring that capture how m otor symptoms fluctuate during the day in response to treatment protocols to help minimize Parkinson's motor symptoms. PDRemote will be a repeatable, automated system clinicians will use to remotely monitor PD motor symptoms on a more continuous basis in a patient's home that should improve outcomes and decrease costs especially for disparate patient populations in areas not in close proximity to movement disorder specialists.

* information listed above is at the time of submission.

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