Automated Imaging Differentiation of Parkinsonism

NCT05913687 | Active Not Recruiting DMC

• 3 other identifiers: IRB202002350PRO000283495U01NS119562
• Study Type: observational
• Target: 315
• Locations: 2 countries
• Sites: 21

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.

Conditions

Parkinson Disease; Multiple System Atrophy, Parkinson Variant; Progressive Supranuclear Palsy

Outcome Measures

Primary Outcomes (1)

• Predicted diagnosis accuracy

  utilizing the automated imaging differentiation of Parkinsonism (AIDP) tool to predict diagnosis compared to the expertise of two movement disorder specialists

  12-18 months

Study Arms (3)

Parkinson's disease

Clinically diagnosed Parkinson's disease

Diagnostic Test: AIDP

Multiple System Atrophy, Parkinsonian variant

Clinically diagnosed Multiple System Atrophy, Parkinsonian variant

Diagnostic Test: AIDP

Progressive Supranuclear Palsy

Clinically diagnosed Progressive Supranuclear Palsy

Diagnostic Test: AIDP

Interventions

AIDP DIAGNOSTIC_TEST

Machine learning algorithm of imaging data

Multiple System Atrophy, Parkinsonian variant; Parkinson's disease; Progressive Supranuclear Palsy

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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 \*As of 11/9/23, we have filled the cohorts for both PD and PSP patients. We are only enrolling MSAp patients at this time.

You may qualify if:

• Parkinson's disease diagnosis within 5-9 years of baseline date
• MSAp diagnosis
• PSP diagnosis

You may not qualify if:

• metal implants in the body that preclude an MRI (pacemaker, metallic clip, neurostimulator, etc)
• claustrophobia
• pregnancy

Sponsors & Collaborators

• Beth Israel Deaconess Medical Center: collaborator
• Duke University: collaborator
• Johns Hopkins University: collaborator
• Massachusetts General Hospital: collaborator
• Northwestern University: collaborator
• Ottawa Hospital Research Institute: collaborator
• Penn State University: collaborator
• University of Alabama at Birmingham: collaborator
• University of California, San Diego: collaborator
• University of California, San Francisco: collaborator
• University of Chicago: collaborator
• University of Michigan: collaborator
• University of Minnesota: collaborator
• University of South Florida: collaborator
• Centre for Addiction and Mental Health: collaborator
• Wake Forest University: collaborator
• Washington University School of Medicine: collaborator
• University of Kentucky: collaborator
• National Institute of Neurological Disorders and Stroke (NINDS): collaborator
• University of Florida: lead
• Augusta University: collaborator
• Albany Medical College: collaborator

Study Sites (21)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

University of California San Diego

La Jolla, California, 92037, United States

Location

University of California San Francisco

San Francisco, California, 94158, United States

Location

University of Florida

Gainesville, Florida, 32611, United States

Location

University of South Florida

Tampa, Florida, 33613, United States

Location

Augusta University

Augusta, Georgia, 30912, United States

Location

Northwestern University

Chicago, Illinois, 60611, United States

Location

University of Chicago

Chicago, Illinois, 60637, United States

Location

University of Kentucky

Lexington, Kentucky, 40536, United States

Location

Johns Hopkins University

Lutherville, Maryland, 21093, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Massachusetts General Hospital

Charlestown, Massachusetts, 02129, United States

Location

University of Michigan

Ann Arbor, Michigan, 48106, United States

Location

University of Minnesota

Minneapolis, Minnesota, 55414, United States

Location

Washington University in St. Louis

St Louis, Missouri, 63110, United States

Location

Albany Medical College

Albany, New York, 12020, United States

Location

Duke University Medical Center

Durham, North Carolina, 22705, United States

Location

Wake Forest University

Winston-Salem, North Carolina, 27157, United States

Location

Pennsylvania State University

Hershey, Pennsylvania, 17033, United States

Location

Ottawa Hospital Research Institute

Ottawa, K1Y 4E9, Canada

Location

Centre for Addiction and Mental Health

Toronto, M5T 2S8, Canada

Location

MeSH Terms

Conditions

Parkinson Disease; Multiple System Atrophy; Supranuclear Palsy, Progressive

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Primary Dysautonomias; Autonomic Nervous System Diseases; Ophthalmoplegia; Ocular Motility Disorders; Cranial Nerve Diseases; Tauopathies; Paralysis; Neurologic Manifestations; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 13, 2023
• First Posted: June 22, 2023
• Study Start: July 22, 2021
• Primary Completion: March 31, 2026
• Study Completion: March 31, 2026
• Last Updated: January 16, 2026

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2); US (19)