Facilitating Diagnostics and Prognostics of Parkinsonian Syndromes Using Neuroimaging

NCT03872102 | Recruiting DMC

• 1 other identifier: STU-2018-0428
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

The goals of this study are: 1) to identify biomarkers using neuroimaging that are associated with progression rate using statistical methods, and 2) to identify biomarkers that are associated with the differential diagnosis of Parkinson's disease and atypical parkinsonism.

Conditions

Parkinson Disease; Multiple System Atrophy; Progressive Supranuclear Palsy

Outcome Measures

Primary Outcomes (2)

• Imaging biomarker of progression rate

  The imaging biomarker consists of a machine learning model that distinguishes fast and slow progressors using the neuroimaging data. The performance of the model will be assessed quantitatively using widely adopted performance metrics: sensitivity, specificity, and accuracy.

  Baseline

• Imaging biomarker that discriminates different neurodegenerative diseases

  The imaging biomarker consists of a machine learning model that differentiates the parkinsonian diseases: PD, PSP, and MSA using the neuroimaging data. The performance of the model will be assessed quantitatively using widely adopted performance metrics from the classification confusion matrix. The metrics will include disease sensitivity, disease specificity, and disease specific accuracy and overall accuracy.

  Baseline

Secondary Outcomes (5)

• Change from baseline in MDS-UPDRS score

  Baseline, 6-8 Month Visit, End of Study Visit (12-16 Month)

• Change from baseline in Unified Multiple System Atrophy Rating Scale (UMSARS) score

  Baseline, 6-8 Month Visit, End of Study Visit (12-16 Month)

• Change from baseline in Progressive Supranuclear Palsy Rating Scale (PSPRS) score

  Baseline, 6-8 Month Visit, End of Study Visit (12-16 Month)

• Change from baseline in Parkinson disease questionnaire

  Baseline, 6-8 Month Visit, End of Study Visit (12-16 Month)

• Change from baseline in Schwab and England Activities of Daily Living Scale

  Baseline, 6-8 Month Visit, End of Study Visit (12-16 Month)

Study Arms (2)

Aim 1: Develop a biomarker of PD disease progression rate

For Aim 1, we will enroll PD subjects spanning a range of progression rates that have been tracked at UT Southwestern Medical Center. Multimodal neuroimaging will be acquired from each subject. We will evaluate imaging data and known data on clinical progression using statistical techniques to determine a biomarker that associates with progression rate.

Aim 2: Develop a biomarker to distinguish between PD, PSP, MSA

For Aim 2, we will recruit subjects with PD, MSA, and PSP. We will also recruit healthy age/sex-matched controls. All subjects will complete a series of clinical assessments at three different time points, roughly 6-8 months apart: * Levodopa Equivalent Daily Dose * Parkinson disease questionnaire * Schwab and England ADL Scale * MDS-UPDRS (PD and healthy controls only) * UMSARS (MSA subjects only) * PSPRS (PSP subjects only) Multimodal neuroimaging will be acquired from each subject. We will evaluate imaging data from the participants along with prospectively collected information on clinical progression using statistical techniques to determine a biomarker that associates with the differentiation of PD, MSA, and PSP.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

There are 4 study populations: 1. Subjects with PD 2. Subjects with PSP 3. Subjects with MSA 4. Control subjects

You may qualify if:

• For Aim 1:
• Diagnosis of Parkinson disease
• Existence of sufficient clinical data from previous UTS Southwestern longitudinal study to determine progression rate (categorized as fast or slow)
• Availability of suitable matched participant in the alternate progression group (fast or slow)
• Willingness to participate in the imaging studies required for this study and to provide written informed consent
• For Aim 2:
• PD subjects will be recruited in accordance with the MDS Clinical Diagnostic Criteria for PD.
• Duration of PD (since diagnosis) is \< 5 years
• Willing to participate in imaging and clinical scoring visits, and provide written informed consent
• Subject and investigator agree that it is highly likely subject will be able to participate throughout the 2-year study period (no plans to move)
• MSA subjects will be recruited in accordance with the Second Consensus Statement on Diagnosis of Multiple System Atrophy.
• Duration of MSA (since diagnosis) is \< 5 years
• Willing to participate in imaging and clinical scoring visits, and provide written informed consent
• Subject and investigator agree that it is highly likely subject will be able to participate throughout the 2-year study period (no plans to move away during the study)
• Willing to participate in imaging and clinical scoring visits, and provide written informed consent

You may not qualify if:

• For Aims 1 and 2:
• Any contraindications to undergoing the multimodal imaging program
• All females of child-bearing potential, between the ages of 18-55, will be excluded from the study, unless they are confirmed to be not pregnant with a pregnancy test prior to scanning
• This study will require constant clear communication throughout the duration of the study; therefore, non-English speakers will be excluded
• Right-handed finger amputees
• Cast on right hand or fingers at the time of enrollment
• Has clinically significant liver, kidney, lung, metabolic or hormone disturbances which pose safety risk
• Has a current clinically significant heart disease that poses a safety risk
• Has a current clinically significant infectious disease or a medical comorbidity which poses a safety risk
• Has a history of relevant severe drug allergy or hypersensitivity
• Have a history of drug, alcohol, or substance dependence or abuse within the last year, or prior prolonged history of dependence or abuse
• Currently undergoing chemotherapy or radiation for cancer
• Recreational drug use in past six months
• Central nervous systems disease or brain injury that would preclude participation in this study
• Psychiatric or neurological disorder that would preclude participation in this study

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (1)

UT Southwestern Medical Center

Dallas, Texas, 75390, United States

RECRUITING

Related Publications (1)

• Tomlinson CL, Stowe R, Patel S, Rick C, Gray R, Clarke CE. Systematic review of levodopa dose equivalency reporting in Parkinson's disease. Mov Disord. 2010 Nov 15;25(15):2649-53. doi: 10.1002/mds.23429.

  PMID: 21069833 BACKGROUND

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 Officials

• Padraig E O'Suilleabhain, MD

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

• Albert Montillo, PhD

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Padraig E O'Suilleabhain, MD

CONTACT

214-648-2943; padraig.osuilleabhain@utsouthwestern.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 7, 2019
• First Posted: March 13, 2019
• Study Start: March 28, 2019
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: January 27, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)