Validating Diagnostic and Screening Procedures for Pre-Motor Parkinson's Disease
Annual rept. 1 Apr 2011-31 Mar 2012
PARKINSONS INST SUNNYVALE CA
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The goal of this 24-month proposal is to establish the critical infrastructure for the initiation of a five year prospective follow-up study to identify those at risk for developing PD or a related Lewy body disorder in three study populations. The ultimate goal of this work is to develop low-cost non-invasive screening methods to detect pre-motor Parkinson s disease PD that can be implemented population-wide. Our hypothesis is that cardiac autonomic dysfunction assessed as heart rate variability HRV using a standard EKG, in combination with hyposmia and other simple screening tests, will be highly predictive of abnormalities in DAT imaging and ultimately predict the emergence of full-blown PD or a related Lewy body disorder. As of 31 March, 2012, we have established collaborative relationships with San Francisco Bay Area sleep medicine clinics and neurologists in order to recruit study subjects. After pre-IRB review by the Regulatory Compliance Specialist, all study documents have been approved by our local IRB, and forwarded to USAMRMC ORP HRPO for final review. These include the study protocol and flowchart, consent forms, recruitment materials, screening and diagnostic questionnaires, data collection forms, and clinical and risk factor questionnaires. Databases and operations procedures are in development, and receipt of data from collaborating institutions will commence upon receipt of HRPO approval.
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- Medicine and Medical Research