Facilitating Diagnostics and Prognostics of Parkinsonian Syndromes Using Neuroimaging

Recruiting now

Conditions studied: Parkinson Disease, Multiple System Atrophy, Progressive Supranuclear Palsy

In brief

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.

Key facts

Study ID: NCT03872102
Run by: University of Texas Southwestern Medical Center
People needed: 90
Starts: 2019-03-28
Expected to finish: 2026-12-31
Last updated by the study team: 2026-01-27

Who can join

Age: any. Sex: any. Healthy volunteers: accepted.

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)
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)

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
Inability to keep or maintain research appointments
For Aim 1:
Severe disease progression such that participation in the imaging tests would be impossible or difficult
Non-availability of a suitable matched participant in the alternate progression group (fast or slow)
For Aim 2:
PD subjects
Unequivocal cerebellar abnormalities
Downward vertical gaze limitation or slowing of downward saccades
Diagnosis of behavioral variant frontotemporal dementia or primary progressive aphasia
Parkinsonian features restricted to the lower limbs for > 3 years

Where it is running

UT Southwestern Medical Center — Dallas, Texas, United States (enrolling)

Full record on ClinicalTrials.gov

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