U01NS119562

Web-Based Automated Imaging Differentiation of Parkinsonism - Summary

Across the globe, there has been a considerable growth in the number of people diagnosed with Parkinsonism. Estimates indicate that from 1990 to 2015, the number of Parkinsonism diagnoses doubled, with more than 6 million people currently carrying the diagnosis. By the year 2040, it is projected that 12 to 14.2 million people will be diagnosed with Parkinsonism.

Parkinson's Disease (PD), Multiple System Atrophy Parkinsonian Variant (MSAP), and Progressive Supranuclear Palsy (PSP) are neurodegenerative forms of Parkinsonism. These conditions can be difficult to diagnose as they share similar motor and non-motor features, and they each have an increased chance of developing dementia. In the first five years of a PD diagnosis, about 58% of PD cases are misdiagnosed, and of these misdiagnoses, about half have either MSA or PSP.

Since PD, MSAP, and PSP require unique treatment plans and different medications, and clinical trials testing new medications require the correct diagnosis, there is an urgent need for both clinic-ready and clinical-trial ready markers for differential diagnosis of PD, MSAP, and PSP.

Over the past decade, diffusion imaging has been developed as an innovative biomarker for differentiating PD, MSAP, and PSP. In this proposal, we will leverage our extensive experience to create a web-based software tool that can process diffusion imaging data from anywhere in the world. We will disseminate and test the tool in the largest prospective cohort of participants with Parkinsonism (PD, MSAP, PSP), working closely with the Parkinson Study Group.

The reason to test this in the Parkinson Study Group network is because they are the community that evaluates phase II and phase III clinical trials in Parkinsonism. This web-based software tool will be capable of reading raw diffusion imaging data, performing quality assurance procedures, analyzing the data using a validated pipeline, and providing imaging metrics and diagnostic probability.

We will test the performance of the Web-Based Automated Imaging Differentiation of Parkinsonism (WAID-P) by enrolling 315 total subjects (105 PD, 105 MSAP, 105 PSP) across 21 sites in the Parkinson Study Group. Each site will perform imaging, clinical scales, diagnosis, and will upload the data to the web-based software tool. The clinical diagnosis will be blinded to the diagnostic algorithm, and the imaging diagnosis will be compared to the movement disorders trained neurologist diagnosis.

We will also enroll a portion of the cohort into a brain bank to ascertain pathological confirmation and to test the algorithm against cases with post-mortem diagnoses. The final outcome will be to disseminate a validated diagnostic algorithm to the Parkinson neurological and radiological community and to make it available to all on a website.

University Of Florida

(1) TO SUPPORT EXTRAMURAL RESEARCH FUNDED BY THE NATIONAL INSTITUTE OF NEUROLOGICAL DISORDERS AND STROKE (NINDS) INCLUDING: BASIC RESEARCH THAT EXPLORES THE FUNDAMENTAL STRUCTURE AND FUNCTION OF THE BRAIN AND THE NERVOUS SYSTEM, RESEARCH TO UNDERSTAND THE CAUSES AND ORIGINS OF PATHOLOGICAL CONDITIONS OF THE NERVOUS SYSTEM WITH THE GOAL OF PREVENTING THESE DISORDERS, RESEARCH ON THE NATURAL COURSE OF NEUROLOGICAL DISORDERS, IMPROVED METHODS OF DISEASE PREVENTION, NEW METHODS OF DIAGNOSIS AND TREATMENT, DRUG DEVELOPMENT, DEVELOPMENT OF NEURAL DEVICES, CLINICAL TRIALS, AND RESEARCH TRAINING IN BASIC, TRANSLATIONAL AND CLINICAL NEUROSCIENCE. THE INSTITUTE IS THE LARGEST FUNDER OF BASIC NEUROSCIENCE IN THE US AND SUPPORTS RESEARCH ON TOPICS INCLUDING BUT NOT LIMITED TO: DEVELOPMENT OF THE NERVOUS SYSTEM, INCLUDING NEUROGENESIS AND PROGENITOR CELL BIOLOGY, SIGNAL TRANSDUCTION IN DEVELOPMENT AND PLASTICITY, AND PROGRAMMED CELL DEATH, SYNAPSE FORMATION, FUNCTION, AND PLASTICITY, LEARNING AND MEMORY, CHANNELS, TRANSPORTERS, AND PUMPS, CIRCUIT FORMATION AND MODULATION, BEHAVIORAL AND COGNITIVE NEUROSCIENCE, SENSORIMOTOR LEARNING, INTEGRATION AND EXECUTIVE FUNCTION, NEUROENDOCRINE SYSTEMS, SLEEP AND CIRCADIAN RHYTHMS, AND SENSORY AND MOTOR SYSTEMS. IN ADDITION, THE INSTITUTE SUPPORTS BASIC, TRANSLATIONAL AND CLINICAL STUDIES ON A NUMBER OF DISORDERS OF THE NERVOUS SYSTEM INCLUDING (BUT NOT LIMITED TO): STROKE, TRAUMATIC INJURY TO THE BRAIN, SPINAL CORD AND PERIPHERAL NERVOUS SYSTEM, NEURODEGENERATIVE DISORDERS, MOVEMENT DISORDERS, BRAIN TUMORS, CONVULSIVE DISORDERS, INFECTIOUS DISORDERS OF THE BRAIN AND NERVOUS SYSTEM, IMMUNE DISORDERS OF THE BRAIN AND NERVOUS SYSTEM, INCLUDING MULTIPLE SCLEROSIS, DISORDERS RELATED TO SLEEP, AND PAIN. PROGRAMMATIC AREAS, WHICH ARE PRIMARILY SUPPORTED BY THE DIVISION OF NEUROSCIENCE, ARE ALSO SUPPORTED BY THE DIVISION OF EXTRAMURAL ACTIVITIES, THE DIVISION OF TRANSLATIONAL RESEARCH, THE DIVISION OF CLINICAL RESEARCH, THE OFFICE OF TRAINING AND WORKFORCE DEVELOPMENT, THE OFFICE OF PROGRAMS TO ENHANCE NEUROSCIENCE WORKFORCE DEVELOPMENT, AND THE OFFICE OF INTERNATIONAL ACTIVITIES. (2) TO EXPAND AND IMPROVE THE SMALL BUSINESS INNOVATION RESEARCH (SBIR) PROGRAM, TO INCREASE PRIVATE SECTOR COMMERCIALIZATION OF INNOVATIONS DERIVED FROM FEDERAL RESEARCH AND DEVELOPMENT, TO INCREASE SMALL BUSINESS PARTICIPATION IN FEDERAL RESEARCH AND DEVELOPMENT, AND TO FOSTER AND ENCOURAGE PARTICIPATION OF SOCIALLY AND ECONOMICALLY DISADVANTAGED SMALL BUSINESS CONCERNS AND WOMEN-OWNED SMALL BUSINESS CONCERNS IN TECHNOLOGICAL INNOVATION. TO UTILIZE THE SMALL BUSINESS TECHNOLOGY TRANSFER (STTR) PROGRAM, TO STIMULATE AND FOSTER SCIENTIFIC AND TECHNOLOGICAL INNOVATION THROUGH COOPERATIVE RESEARCH AND DEVELOPMENT CARRIED OUT BETWEEN SMALL BUSINESS CONCERNS AND RESEARCH INSTITUTIONS, TO FOSTER TECHNOLOGY TRANSFER BETWEEN SMALL BUSINESS CONCERNS AND RESEARCH INSTITUTIONS, TO INCREASE PRIVATE SECTOR COMMERCIALIZATION OF INNOVATIONS DERIVED FROM FEDERAL RESEARCH AND DEVELOPMENT, AND TO FOSTER AND ENCOURAGE PARTICIPATION OF SOCIALLY AND ECONOMICALLY DISADVANTAGED SMALL BUSINESS CONCERNS AND WOMEN-OWNED SMALL BUSINESS CONCERNS IN TECHNOLOGICAL INNOVATION.

93.853 - Extramural Research Programs in the Neurosciences and Neurological Disorders

National Institute of Neurological Disorders and Stroke (NNDS) [HHS - NIH]

Gainesville, Florida 326110001 United States

Single Zip Code

Clinical Validation of Candidate Biomarkers for Neurological Diseases (U01 Clinical Trial Optional) (PAR-18-664)

Amendment Since initial award the total obligations have increased 211% from $1,553,260 to $4,837,150.