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Automated Imaging Differentiation of Parkinsonism (AIDP)

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
First Posted : June 22, 2023
Last Update Posted : August 18, 2023
Sponsor:
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 :
  1. Predicted diagnosis accuracy [ Time Frame: 12-18 months ]
    utilizing the automated imaging differentiation of Parkinsonism (AIDP) tool to predict diagnosis compared to the expertise of two movement disorder specialists


Eligibility Criteria
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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   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 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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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT05913687    
Other Study ID Numbers: IRB202002350
PRO00028349 ( Other Identifier: UF )
5U01NS119562 ( U.S. NIH Grant/Contract )
First Posted: June 22, 2023    Key Record Dates
Last Update Posted: August 18, 2023
Last Verified: August 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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Parkinson Disease
Multiple System Atrophy
Shy-Drager Syndrome
Parkinsonian Disorders
Supranuclear Palsy, Progressive
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Synucleinopathies
Neurodegenerative Diseases
 Primary Dysautonomias
Autonomic Nervous System Diseases
Hypotension
Vascular Diseases
Cardiovascular Diseases
Ophthalmoplegia
Ocular Motility Disorders
Cranial Nerve Diseases
Tauopathies
Paralysis
Neurologic Manifestations
Eye Diseases