The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT05913687
Recruitment Status : **RECRUITING NOW**
First Posted : June 22, 2023
Last Update Posted : June 22, 2023
Sponsor:
University of Florida
Collaborators:
Augusta University
Albany Medical College
Beth Israel Deaconess Medical Center
Duke University
Johns Hopkins University
Massachusetts General Hospital
Northwestern University
Ottawa Hospital Research Institute
Penn State University
University of Alabama at Birmingham
University of California, San Diego
University of California, San Francisco
University of Chicago
University of Michigan
University of Minnesota
University of South Florida
Centre for Addiction and Mental Health
Wake Forest University
Washington University School of Medicine
University of Kentucky
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by (Responsible Party):
University of Florida
Study Description
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Brief Summary:
The purpose of this study is to test the performance of the AID-P 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.
Condition or disease
Intervention/treatment
Parkinson Disease Multiple System Atrophy, Parkinson Variant Progressive Supranuclear Palsy
Diagnostic Test: AIDP
Study Design
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Study Type :
Observational
Estimated Enrollment :
315 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
Automated Imaging Differentiation of Parkinsonism
Actual Study Start Date :
July 22, 2021
Estimated Primary Completion Date :
March 31, 2026
Estimated Study Completion Date :
March 31, 2026
Resource links provided by the National Library of Medicine
Groups and Cohorts
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Group/Cohort
Intervention/treatment
Parkinson’s disease
Clinically diagnosed Parkinson’s disease
Diagnostic Test: AIDP
Machine learning algorithm of imaging data
Multiple System Atrophy, Parkinsonian variant
Clinically diagnosed Multiple System Atrophy, Parkinsonian variant
Diagnostic Test: AIDP
Machine learning algorithm of imaging data
Progressive Supranuclear Palsy
Clinically diagnosed Progressive Supranuclear Palsy
Diagnostic Test: AIDP
Machine learning algorithm of imaging data
Outcome Measures
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Primary Outcome Measures :
Predicted diagnosis accuracy [ Time Frame: 12-18 months ]
Eligibility Criteria
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Information from the National Library of Medicine
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
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Ages Eligible for Study: Â
40 Years to 80 Years  (Adult, Older Adult)
Sexes Eligible for Study: Â
All
Accepts Healthy Volunteers: Â
No
Sampling Method: Â
Non-Probability Sample
Study Population
Adults between the ages of 40 and 80 who meet one of the three diagnoses: PD, MSAp, or PSP
Criteria
Inclusion Criteria:
Parkinson’s disease diagnosis within 5-9 years of baseline date
MSAp diagnosis
PSP diagnosis
Exclusion Criteria:
metal implants in the body that preclude an MRI (pacemaker, metallic clip, neurostimulator, etc)
claustrophobia
pregnancy
Contacts and Locations
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Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05913687
Contacts
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Contact: David Vaillancourt, PhD
352-294-1770
vcourt@ufl.edu
Locations
Show 21 study locations
Sponsors and Collaborators
University of Florida
Augusta University
Albany Medical College
Beth Israel Deaconess Medical Center
Duke University
Johns Hopkins University
Massachusetts General Hospital
Northwestern University
Ottawa Hospital Research Institute
Penn State University
University of Alabama at Birmingham
University of California, San Diego
University of California, San Francisco
University of Chicago
University of Michigan
University of Minnesota
University of South Florida
Centre for Addiction and Mental Health
Wake Forest University
Washington University School of Medicine
University of Kentucky
National Institute of Neurological Disorders and Stroke (NINDS)
More Information
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Responsible Party:
University of Florida
ClinicalTrials.gov Identifier:
NCT05913687 Â Â
Other Study ID Numbers:
IRB202002350PRO00028349 ( Other Identifier: UF )5U01NS119562 ( U.S. NIH Grant/Contract )
First Posted:
June 22, 2023 Â Â Key Record Dates
Last Update Posted:
June 22, 2023
Last Verified:
June 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:
No
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Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
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Cardiovascular DiseasesParkinson DiseaseMultiple System AtrophyShy-Drager SyndromeSupranuclear Palsy, ProgressiveParkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathies
Neurodegenerative DiseasesPrimary DysautonomiasAutonomic Nervous System DiseasesHypotensionVascular DiseasesOphthalmoplegiaOcular Motility DisordersCranial Nerve DiseasesTauopathiesParalysisNeurologic ManifestationsEye Diseases
Source: View full study details on ClinicalTrials.gov
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. By listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
