Estimating Progression Rate and Distinguishing Parkinsonian Syndromes Using Imaging and Deep Learning
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03872102|
Recruitment Status : Active, not recruiting
First Posted : March 13, 2019
Last Update Posted : June 27, 2019
|Condition or disease|
|Parkinson Disease Multiple System Atrophy Progressive Supranuclear Palsy|
Management of patients with parkinsonian symptoms has two critical gaps: (1) there is no clinical test to objectively predict the disease progression rate in an individual with Parkinson disease (PD), and (2) no trustworthy test exists for the early differential diagnosis of conditions that exhibit parkinsonian symptoms and signs. This 2-year study develops a multi-modal neuroimaging biomarker that enables the prediction of disease progression rate in PD and an imaging 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; multimodal imaging of a defined population of PD subjects previously followed as part of the Parkinson disease biomarker program at University of Texas (UT) Southwestern, and recruitment of new study subjects with PD, MSA, and PSP who will be followed clinically over 2 years and who will undergo multimodal imaging 3 times during follow-up.
Participants will be asked to undergo MRI (magnetic resonance imaging) MEG (magnetoencephalography), and EEG (electroencephalography) while on PD medications and will additionally repeat the MRI, MEG, and EEG while in a 12-hour off state following withholding of the usual morning dose of levodopa.
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.
|Study Type :||Observational|
|Estimated Enrollment :||90 participants|
|Official Title:||Quantitative Diagnostics of Parkinsonian Syndromes Using Multi-modal Neuroimaging and Deep Learning|
|Actual Study Start Date :||March 28, 2019|
|Estimated Primary Completion Date :||March 2021|
|Estimated Study Completion Date :||May 2021|
PD subjects will be recruited in accordance with the MDS Clinical Diagnostic Criteria for PD.
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.
MSA subjects will be recruited in accordance with the Second Consensus Statement on Diagnosis of Multiple System Atrophy
Control subjects will be roughly age and sex matched with the subjects in the PD cohort, with no history or examination findings suggestive of any neurodegenerative disease.
- Change from baseline in MDS-UPDRS score at 24 months. [ Time Frame: 2 years ]
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 II: 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.
- Change from baseline in Unified Multiple System Atrophy Rating Scale (UMSARS) score at 24 months. [ Time Frame: 2 years ]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.
- Change from baseline in Progressive Supranuclear Palsy Rating Scale (PSPRS) score at 24 months [ Time Frame: 2 years ]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 are 6 items with 16 points, and the gait area 5 items with 20 points. Negative change from baseline scores indicate improvement.
- Change levodopa equivalent daily dose (LEDD) from baseline at 24 months [ Time Frame: 2 years ]The LEDD is calculated according to Tomlinson, et. and updated for newer dopaminergic drugs. This number is achieved by adjusting for relative clinical potency of various dopaminergic agents such that the LEDD is an approximation of the dopaminergic stimulation were the patient treated with only levodopa. Negative change from baseline scores indicate improvement.
- Parkinson disease questionnaire, 39 item [ Time Frame: 2 years ]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.
- Montreal Cognitive Assessment [ Time Frame: 2 years ]The Montreal Cognitive Assessment (MoCA) is a cognitive screening test that has shown superior ability to detect both mild cognitive impairment and dementia in PD. There are validated cut-offs in published literature separating normal cognitive function, mild cognitive impairment, and dementia. The scale ranges from 0-30 with the the highest score representing normal cognition. An increase in the MoCA over time would indicate improvement in cognitive function.
- Schwab and England Activities of Daily Living Scale [ Time Frame: 2 years ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03872102
|United States, Texas|
|UT Southwestern Medical Center|
|Dallas, Texas, United States, 75390|
|Principal Investigator:||Richard B Dewey, MD||UT Southwestern Medical Center|