grant

Core B: Clinical Resource Core

Organization UNIVERSITY OF MICHIGAN AT ANN ARBORLocation ANN ARBOR, UNITED STATESPosted 30 Sept 2021Deadline 30 Jun 2027
NIHUS FederalResearch GrantFY2025Abnormal gaitActive Follow-upAgeAttentionBiometricsBiometryBiostatisticsClassificationClinicClinicalClinical DataClinical assessmentsCognitionCollaborationsCommon Data ElementConsensusDataData AnalysesData AnalysisData BasesData CollectionData Management CoreDatabasesDecision MakingDiagnosticDyskinesia SyndromesEligibilityEligibility DeterminationEnrollmentEvaluationFosteringFoundationsGait abnormalityGait disorderGait disturbancesGait dysfunctionGait impairmentGenderGoalsHIPAAHealth Insurance Portability and Accountability ActIRBIRBsInfrastructureInstitutional Review BoardsInvestigatorsKennedy Kassebaum ActMagnetic ResonanceMethodsMichiganMotorMovement Disorder SyndromesMovement DisordersNINDSNational Institute of Neurological Diseases and StrokeNational Institute of Neurological Disorders and StrokeNeuropsychologiesNeuropsychologyNewsletterOn-Line SystemsOnline SystemsOrganization ChartsPETPET ScanPET imagingPETSCANPETTPL 104-191PL104-191Paralysis AgitansParkinsonParkinson DiseasePatientsPhenotypePoliciesPopulationPositron Emission Tomography Medical ImagingPositron Emission Tomography ScanPositron-Emission TomographyPrimary ParkinsonismProcessProtocol ScreeningPublic Law 104-191Quality ControlRad.-PETRegistriesRegulationResearch PersonnelResearch ResourcesResearch SubjectsResearchersResolutionResourcesStandardizationSystematicsUnited States Health Insurance Portability and Accountability ActUniversitiesWalking impairmentactive followupagescholinergiccohortconferenceconventiondata basedata exchangedata interpretationdata managementdata management and coordinating centerdata management centerdata transferdata transmissiondepositoryenrollexperiencefollow upfollow up assessmentfollow-upfollowed upfollowupfollowup assessmenthuman subjectin vivoinstrumentneural imagingneuro-imagingneuroimagingneurological imagingneuropsychologiconline computeroperationoperationsorganizational structurepositron emission tomographic (PET) imagingpositron emission tomographic imagingpositron emitting tomographyrecruitrepositoryresolutionssummitsymposiasymposiumweb based
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Full Description

CORE B: SUMMARY/ABSTRACT
The Clinical Resource Core (CRC; Core B) will provide support for human subjects Projects I and III of the

University of Michigan (U-M) Udall Center through recruitment, enrollment, and detailed clinical assessment of

Parkinson disease (PD) subjects and age- and gender-matched control (NC) subjects. A unique feature of the

proposed U-M Udall Center is that it will leverage the unique deeply clinical and neuroimaging phenotyped PD

population from our previous Udall Center (09/2014-08/2020). The cohort of PD subjects comprehensively

assessed in the previous U-M Udall Center cycle will be recruited for additional longitudinal assessments with a

supplemental cohort of new PD subjects. The CRC has standardized methods for data collection, entry, and

verification, as developed by the Biostatistics and Data Management Core (BDMC; Core D), compliant with

HIPAA and IRB regulations. Data collected is consistent with NINDS Common Data Elements to facilitate transfer

of data to the NINDS Data Management Repository using ProFORMS. The CRC will closely collaborate with the

Neuroimaging Resource Core (NRC; Core C) to coordinate in vivo neuroimaging assessments of subjects.

The CRC will serve as the liaison between Project III and the investigators of the Dutch Parkinson and

Cognition (DUPARC) study at the University of Groningen (P.I. Dr. Teus van Laar). The CRC will continue to

foster existing collaborations with the Pacific Udall Center (P.I. Dr. Thomas Montine) and the University of

Rochester Udall Center (P.I. Dr. Ray Dorsey). The specific goals of the CRC are:

1. To recruit, enroll, and retain PD subjects (net enrollment target of N=100 eligible PD subjects) and age- and

gender-matched NC subjects (N=20) for the U-M Udall Center Projects I and III in support of their scientific

goals.

2. To comprehensively assess all subjects with well-established clinical, motor function, and

neuropsychological instruments at baseline and follow-up.

3. To provide the organizational structure and operations oversight for the U-M Udall Center Projects I and III

and interact and coordinate with other Cores to assure prompt neuroimaging assessment (NRC) and data

transfer and analysis (BDMC).

4. Facilitate and coordinate data transfer from the University of Groningen DUPARC study.

5. Support existing collaborations with other Udall Centers and facilitate transfer of data to and from these Udall

Centers

Grant Number: 5P50NS123067-05
NIH Institute/Center: NIH

Principal Investigator: Nicolaas Bohnen

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