Parkinson DiseaseNCT03872102
Facilitating Diagnostics and Prognostics of Parkinsonian Syndromes Using Neuroimaging
An observational study of Parkinson Disease and Multiple System Atrophy, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Parkinson Disease, Multiple System Atrophy, Progressive Supranuclear Palsy
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Mar 2019to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: There are 4 study populations: 1. Subjects with PD 2. Subjects with PSP 3. Subjects with MSA 4. Control subjects
Who may be able to join
- 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:
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- 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)
Who cannot join
- 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
Show all 55Show fewer
- 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
- Treatment with dopamine blockers or depleters in a time course consistent with drug induced parkinsonism
- Absence of an observable response to high dose levodopa despite moderate disease severity
- Expert considers a diagnosis of alternative syndrome more likely than PD
- Rapid progression of gait impairment requiring wheelchair within 5 years of onset
- Complete absence of progression of motor symptoms over 5 years unless due to treatment
- Early bulbar dysfunction within the first 5 years since diagnosis
- Inspiratory respiratory dysfunction (stridor or frequent sighs)
- Severe autonomic failure in the first 5 years
- Recurrent falls (>1 per year) because of impaired balance in the first 3 years
- Disproportionate dystonic anterocollis or hand contractures of hands or feet within 10 years
- Absence of any of the common non-motor features of PD despite 5 years of disease
- Otherwise unexplained pyramidal tract signs (weakness, hyperreflexia, or extensor toe signs)
- Bilateral symmetric parkinsonism
- MSA subjects
- Clinically significant neuropathy
- Hallucinations not induced by drugs
- Onset after age 75 years
- Family history of ataxia or parkinsonism
- White matter lesions suggesting multiple sclerosis
- PSP subjects
- Predominant, otherwise unexplained impairment of episodic memory, suggestive of AD (Alzheimer's disease)
- Predominant, otherwise unexplained autonomic failure, e.g., orthostatic hypotension (orthostatic reduction in blood pressure after 3 minutes standing > 30 mm Hg systolic or > 15 mm Hg diastolic), suggestive of multiple system atrophy or Lewy body disease
- Predominant, otherwise unexplained visual hallucinations or fluctuations in alertness, suggestive of dementia with Lewy bodies
- Predominant, otherwise unexplained multisegmental upper and lower motor neuron signs, suggestive of motor neuron disease (pure upper motor neuron signs are not an exclusion criterion)
- Sudden onset or step-wise or rapid progression of symptoms, in conjunction with corresponding imaging or laboratory findings, suggestive of vascular etiology, autoimmune encephalitis, metabolic encephalopathies, or prion disease
- History of encephalitis
- Prominent appendicular ataxia
- Identifiable cause of postural instability, e.g., primary sensory deficit, vestibular dysfunction, severe spasticity, or lower motor neuron syndrome
- Control subjects
- In the investigator's opinion, an unsuitable candidate to serve as a control
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
UT Southwestern Medical Center
Dallas, Texas, 75390
Pheba Sunny, 214-648-7578, phebaelizabath.sunny@utsouthwestern.edu
About this study
Official title: Quantitative Diagnostics of Parkinsonian Syndromes Using Multi-modal Neuroimaging and Deep Learning
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.
Read the detailed description
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.
- Medical subject headings
- Parkinson Disease, Multiple System Atrophy, Supranuclear Palsy, Progressive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, 6-8 Month Visit, End of Study Visit (12-16 Month)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2019
- Study start28 Mar 2019
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Padraig O'Suilleabhain, University of Texas Southwestern Medical Center
- Investigators
- Padraig E O'Suilleabhain, MD, Principal investigator, University of Texas Southwestern Medical CenterAlbert Montillo, PhD, Principal investigator, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03872102
- Sponsor's protocol ID
- STU-2018-0428
- Status last verified
- Jan 2026
- First submitted
- 7 Mar 2019
- Last updated
- 27 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 21069833
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantitative Diagnostics of Parkinsonian Syndromes Using Multi-modal Neuroimaging and Deep Learning
- ClinicalTrials.gov ID
- NCT03872102
- Acronym / sponsor ID
- STU-2018-0428
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- 28 Mar 2019 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 13 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- There are 4 study populations: 1. Subjects with PD 2. Subjects with PSP 3. Subjects with MSA 4. Control subjects
Key inclusion criteria (24 listed)
- 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
- PD subjects will be recruited in accordance with the MDS Clinical Diagnostic Criteria for PD.
Key exclusion criteria (55 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Imaging biomarker of progression rate
Time frame: Baseline
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.
Imaging biomarker that discriminates different neurodegenerative diseases
Time frame: Baseline
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.
5 secondary outcomes
Change from baseline in MDS-UPDRS score
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
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
Time frame: Baseline, 6-8 Month Visit, End of Study Visit (12-16 Month)
Change from baseline in Parkinson disease questionnaire
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
Time frame: Baseline, 6-8 Month Visit, End of Study Visit (12-16 Month)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2026.
- Background: PubMed 21069833Tomlinson 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Padraig E O'Suilleabhain, MD principal investigator
University of Texas Southwestern Medical Center
Albert Montillo, PhD principal investigator
University of Texas Southwestern Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson Disease and Multiple System Atrophy, run by University of Texas Southwestern Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 24 inclusion and 55 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Padraig E O'Suilleabhain, MD (214-648-2943, padraig.osuilleabhain@utsouthwestern.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Imaging biomarker of progression rate (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03872102, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2026; AzTrials last refreshed its copy on 7 Nov 2026.