ClinicalTrials.gov record NCT03872102
Facilitating Diagnostics and Prognostics of Parkinsonian Syndromes Using Neuroimaging
Quantitative Diagnostics of Parkinsonian Syndromes Using Multi-modal Neuroimaging and Deep Learning
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AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
This prospective observational study collects brain imaging and clinical scores from people with Parkinson disease (PD), multiple system atrophy (MSA), progressive supranuclear palsy (PSP), and matched healthy controls. It aims to identify imaging biomarkers linked to PD progression rate and to imaging patterns that distinguish PD from MSA and PSP. Participants will have multimodal neuroimaging and clinical assessments at baseline and at two follow-up visits about 6–8 months apart; an additional set of PD patients with prior longitudinal data will be used to study progression rates.
What it is studying. The study is testing whether patterns in multimodal neuroimaging can serve as biomarkers for two purposes: (1) predicting an individual’s Parkinson disease progression rate (fast versus slow), and (2) distinguishing Parkinson disease from atypical parkinsonian disorders (MSA and PSP). Imaging data will be analyzed together with clinical scores using statistical and machine‑learning methods.
What the researchers hope to learn. To develop an imaging-based biomarker that associates with PD progression rate. To develop an imaging-based biomarker that differentiates PD, MSA, and PSP. To evaluate those biomarkers using multimodal imaging, clinical scales, and machine‑learning/statistical performance metrics.
What this study is about
The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.
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
The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.
Inclusion criteria
- 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)
Exclusion criteria
- 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
- 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
- a. In the investigator's opinion, an unsuitable candidate to serve as a control
Study description and what participation involves
The study's detailed description, as published on ClinicalTrials.gov.
Detailed description from the registry
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.
AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴
AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
After giving written informed consent, participants will provide clinical information and either contribute existing longitudinal PD data (Aim 1) or be followed prospectively (Aim 2) over about 2 years. Newly recruited participants will have several types of neuroimaging and complete diagnosis‑specific clinical assessments at baseline and at two follow‑up visits roughly 6–8 months apart (examples: MDS‑UPDRS for PD, UMSARS for MSA, PSPRS for PSP, PDQ‑39, and Schwab & England ADL). Women aged 18–55 will be confirmed not pregnant with a pregnancy test prior to any scan. Imaging and clinical data will be analyzed using statistical and machine‑learning techniques.
How the study is structured. A prospective observational cohort study. Participants undergo multiple types of brain imaging and standard clinical rating scales at baseline and at two follow-up visits about 6–8 months apart. One part of the study analyzes existing PD patients with known progression rates to develop a progression biomarker; the other part recruits new PD, MSA, and PSP participants plus matched healthy controls for longitudinal imaging and clinical follow-up. Data are analyzed with statistical and machine‑learning techniques.
Questions you could ask
These questions are suggestions for a conversation with the study team or your own clinician, not advice.
- This is an observational study, so the study itself gives no treatment. What would taking part involve for me, and would it change my usual care?
- The listed sites are in United States. Is any of them reachable for me, and does the study help with travel?
- Which of the eligibility criteria would need to be checked with tests before I could join?
More on progressive supranuclear palsy
This trial is also listed on this site under multiple system atrophy.
Important dates
- Study start
- Mar 28, 2019
- Primary completion
- Dec 31, 2026 (estimated)
- Study completion
- Dec 31, 2026 (estimated)
- Target enrollment
- 90 participants (estimated)
- Last updated on registry
- Jan 27, 2026
- Data verified
- Oct 10, 2026
Sponsor and research team
The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.
- Lead sponsor
- University of Texas Southwestern Medical Center
- Principal investigator
- Padraig O'Suilleabhain, Professor
University of Texas Southwestern Medical Center
Central study contact
If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.
- Padraig E O'Suilleabhain, MD 📞 214-648-2943 ✉ padraig.osuilleabhain@utsouthwestern.edu
Participating sites (1)
- UT Southwestern Medical CenterRecruiting
Dallas, Texas, 75390 · United States
- Pheba Sunny · 214-648-7578 · phebaelizabath.sunny@utsouthwestern.edu
Terms used on this page · explanations by MedicalUpdates.ai
- biomarkers
- Something measurable in the body, such as a blood test result or an imaging finding, that indicates how a condition or treatment is behaving.
- written informed consent
- The process of explaining a study, including its risks and what participation involves, so that a person can decide freely whether to take part. Consent is usually documented in writing, and a participant can choose to leave the study later.
- cohort
- A group of people who share a characteristic, such as a diagnosis, and are studied together. 'Prospective' means they are followed forward from enrolment; 'retrospective' means existing records are reviewed.
- contraindications
- A reason a particular test or treatment should not be used for a person, for example a metal implant that rules out an MRI scan.
- enrollment
- The number of participants a study plans to include, or has included. 'Estimated' means the planned number; 'actual' means the number who joined.
- Inclusion Criteria
- The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
- Exclusion Criteria
- The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.
The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.
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