An observational study in Parkinson Disease, Multiple System Atrophy and Progressive Supranuclear Palsy, sponsored by University of Texas Southwestern Medical Center. Recruiting at 1 site in United States. Per ClinicalTrials.gov, last updated 2026-01-27.
Sponsored by University of Texas Southwestern Medical Center · Observational
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.
Management of patients with parkinsonian symptoms has two critical gaps: (1) there are no clinically accepted biomarkers that may be used to inform disease progression rate in an individual with Parkinson disease (PD), and (2) no biomarkers exist to inform differential diagnosis of conditions that exhibit parkinsonian symptoms and signs. This 2-year study aims to develop a multi-modal neuroimaging biomarker that enables the prediction of disease progression rate in PD, and a biomarker that enables the differential diagnosis of PD, multiple systems atrophy (MSA), progressive supranuclear palsy (PSP), and healthy controls.
This study consists of two parts; neuroimaging of a defined population of mid to late stage PD subjects currently followed at UT Southwestern Medical Center, and recruitment of new subjects with PD, MSA, and PSP who will be followed clinically over 2 years and who will undergo neuroimaging.
Participants will be asked to undergo several types of neuroimaging which will be analyzed using machine learning techniques.
At each study visit of the newly recruited cohorts, appropriate clinical scales will be performed based on their diagnosis and used to track and measure disease severity and progression.
4,573 studies on the registry are indexed under Parkinson Disease; 1,086 are open to participants now.
This study's planned enrollment of 90 is close to the median of 96 across 1,085 observational studies indexed under Parkinson Disease.
Browse Parkinson Disease studies →University of Texas Southwestern Medical Center is the lead sponsor of 1,010 studies on the registry; 199 are open to participants now.
Of its 139 completed or terminated interventional studies of FDA-regulated products, 105 (76%) have results posted.
Counted across the registry records on this site, refreshed daily.
There are 4 study populations:
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
For Aim 1:
For Aim 2:
PD subjects will be recruited in accordance with the MDS Clinical Diagnostic Criteria for PD.
MSA subjects will be recruited in accordance with the Second Consensus Statement on Diagnosis of Multiple System Atrophy.
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.
Control subjects will be recruited who meet the following criteria:
Exclusion Criteria:
For Aims 1 and 2:
For Aim 1:
For Aim 2:
PD subjects
MSA subjects
PSP subjects
Control subjects
a. In the investigator's opinion, an unsuitable candidate to serve as a control
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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.
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.
Time frame: 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.
Time frame: Baseline
Change from baseline in MDS-UPDRS score
The Movement Disorder Society revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) is the standard measure of PD severity used in multiple trials. This consists of four sub scales, Part I: non-motor experiences of daily living (13 items), Part ll: motor experiences of daily living (13 items), Part III: motor examination (18 items), and Part IV: motor complications (six items). Each subscale has a five-point scale ranging from 0-4, where 0 = normal, 1 = slight, 2 = mild, 3 = moderate, and 4 = severe. The total score is the sum of the subscale scores for all four parts and ranges from 0 (no disability) to 200 (total dependence). Negative change from baseline scores indicate improvement.
Time frame: Baseline, 6-8 Month Visit, End of Study Visit (12-16 Month)
Change from baseline in Unified Multiple System Atrophy Rating Scale (UMSARS) score
The Unified Multiple System Atrophy Rating Scale (UMSARS) is the standard scale for measuring disease severity in MSA. This scale is composed of 2 sub-scales: Part I: Historical Review that includes 12 items and Part II: Motor Examination that includes 14 items. All items range from 0 to 4. Each subscale score is the sum of its items and the total UMSARS score is the sum of all 26 items. Hence the total UMSARS score can range from 0 to 104, with 0 meaning no impairment and 104 indicating severe impairment. Negative change from baseline scores indicate improvement.
Time frame: Baseline, 6-8 Month Visit, End of Study Visit (12-16 Month)
Change from baseline in Progressive Supranuclear Palsy Rating Scale (PSPRS) score
The Progressive Supranuclear Palsy Rating Scale (PSPRS) is the standard scale used to quantitate severity in PSP. This is a quantitative measure of disability in participants with PSP. The PSPRS comprises 28 items in 6 areas. The available total score ranges from 0 (normal) to 100. Six items are rated on a 3-point scale (0-2) and 22 are rated on a 5-point scale (0-4). The History/Daily Activities area includes 7 items with ta total maximum of 24 points, the mentation area 4 items with 16 points, the bulbar area 2 items with 8 points, the ocular motor area 4 items with 16 points, the limb motor area 6 items with 16 points, and the gait area 5 items with 20 points. Negative change from baseline scores indicate improvement.
Time frame: Baseline, 6-8 Month Visit, End of Study Visit (12-16 Month)
Change from baseline in Parkinson disease questionnaire
The Parkinson's Disease Questionnaire (PDQ-39) assesses to what degree PD subjects experience difficulties across 8 dimensions of daily living. The 39-question PDQ provides scores (expressed as a percentage) for each of the 8 scales: mobility, activities of daily living, emotional well-being, stigma, social support, cognition, communication, and bodily discomfort. individual items are rated on a 5-point scale (0-4). Higher percentages represent worse quality of life, and a reduction in score over time represents improvement.
Time frame: Baseline, 6-8 Month Visit, End of Study Visit (12-16 Month)
Change from baseline in Schwab and England Activities of Daily Living Scale
The Schwab and England Activities of Daily Living Scale (S\&E) is a commonly used measure of daily function for Parkinson's disease (PD). The S\&E Scale rates a PD patient's function on a scale from 0 indicating worst possible function to 100 indicating no impairment. An increase in the score over time indicates clinical improvement.
Time frame: Baseline, 6-8 Month Visit, End of Study Visit (12-16 Month)
Plan to share: No
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