Clinical trial NCT05913687: Automated Imaging Differentiation of Parkinsonism
Official title: Automated Imaging Differentiation of Parkinsonism
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Parkinson Disease
Multiple System Atrophy, Parkinson Variant
Progressive Supranuclear Palsy
Lead sponsor: University of Florida
Sponsor class: OTHER
Collaborators: name: Augusta University
name: Albany Medical College
name: Beth Israel Deaconess Medical Center
name: Duke University
name: Johns Hopkins University
name: Massachusetts General Hospital
name: Northwestern University
name: Ottawa Hospital Research Institute
name: Penn State University
name: University of Alabama at Birmingham
name: University of California, San Diego
name: University of California, San Francisco
name: University of Chicago
name: University of Michigan
name: University of Minnesota
name: University of South Florida
name: Centre for Addiction and Mental Health
name: Wake Forest University
name: Washington University School of Medicine
name: University of Kentucky
name: National Institute of Neurological Disorders and Stroke (NINDS)
First posted: 2023-06-22
Enrollment: 315
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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.


Eligibility 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

Primary outcomes:
measure: Predicted diagnosis accuracy
timeFrame: 12-18 months
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: La Jolla
country: United States
facility: University of California San Diego
state: California
city: San Francisco
country: United States
facility: University of California San Francisco
state: California
city: Gainesville
country: United States
facility: University of Florida
state: Florida
city: Tampa
country: United States
facility: University of South Florida
state: Florida
city: Augusta
country: United States
facility: Augusta University
state: Georgia
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
city: Lutherville
country: United States
facility: Johns Hopkins University
state: Maryland
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Charlestown
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
city: Saint Louis
country: United States
facility: Washington University in St. Louis
state: Missouri
city: Albany
country: United States
facility: Albany Medical College
state: New York
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest University
state: North Carolina
city: Hershey
country: United States
facility: Pennsylvania State University
state: Pennsylvania
city: Ottawa
country: Canada
facility: Ottawa Hospital Research Institute
city: Toronto
country: Canada
facility: Centre for Addiction and Mental Health
Study officials:
References: