Quantitative Diagnostics of Parkinsonian Syndromes Using Multi-modal Neuroimaging and Deep Learning

Status: Recruiting
Location: See location...
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Healthy Volunteers: t
View:

⁃ 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)

⁃ PSP subjects will be recruited in accordance with the MDS Criteria for Diagnosis of Progressive Supranuclear Palsy and must meet the designation of probable PSP for inclusion.

• 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)

⁃ Control subjects will be recruited who meet the following criteria:

• Roughly age and sex matched with the subjects in the PD cohort

• No history or examination findings suggestive of any neurodegenerative disease

• Normal gait, balance, and eye movements for age

• No clinical evidence for symptomatic orthostatic hypotension

• 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)

Locations
United States
Texas
UT Southwestern Medical Center
RECRUITING
Dallas
Contact Information
Primary
Pheba Sunny
phebaelizabath.sunny@utsouthwestern.edu
214-648-7578
Time Frame
Start Date: 2019-03-28
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 90
Treatments
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.
Sponsors
Leads: University of Texas Southwestern Medical Center

This content was sourced from clinicaltrials.gov