Diagnosis of PD and PD Progression Using DWI

Completed

• Conditions: Parkinson's Disease
• Interventions: Other: Diffusion Weighted Imaging (DWI)

• Registration Number: NCT02837172
• Lead Sponsor: University of Alabama at Birmingham

Brief Summary

This project will evaluate the utility of diffusion tensor imaging (DTI) as an adjunctive method to improve early diagnosis of Parkinson's disease (PD). Two populations will be evaluated in this study: 1) Individuals with uncertain PD diagnosis who receive a DaTscan, and 2) individuals with well characterized PD and healthy controls, drawn from the fully enrolled Parkinson's Progression Markers Initiative (PPMI) PD and control cohorts.

Detailed Description

Specific Aim 1a: Compare the outcome of a DTI based prediction with a contemporaneous clinical DAT scan in 100 subjects with suspected parkinsonism, and determine rate of concordance between the two diagnostic techniques.

Specific Aim 1b: Compare predictive accuracy of a baseline DTI with a "gold standard" expert diagnosis after 36 months of follow up in 100 subjects receiving DaTscan for suspected parkinsonism.

Specific Aim 2a: Use TBM to evaluate volume and cross-sectional caliber (based on point-wise fiber track direction) of the fimbria, pallidonigral tracts, and subthalamic-nigral tracts in PD and healthy controls. Ascertain if changes in white matter volume and caliber can be used to predict presence of PD from the PPMI study. Secondarily, using a model free approach, determine what white matter features based on TBM predict presence of disease.

Specific Aim 2b: Use TBM to determine if an increased rate of change in volume and cross-sectional caliber of the fimbria, and hypertrophic pallidonigral, and subthalamic-nigral tracts identified in aim 2a, are associated with a more rapid rate of disease progression in PD. Secondarily, using a model free approach, determine what white matter features based on TBM predict a faster rate of disease progression over the 5 year course of the PPMI study.

Specific Aim 3a: Compare DTI FA in TD-PD and PIGD-PD in the thalamus and lobule IX of the cerebellum , studying subjects from the PPMI study. Predict signal in these regions will predict phenotypic expression of disease. Using TBM and bootstrapping, determine the relationship between phenotypic expression of disease and white matter input/output pathways from the thalamus, and from lobule IX of the cerebellum.

Study Timeline

• Study Start: 2014-09-25
• Study First Submitted: 2016-04-29
• Study First Submitted QC: 2016-07-18
• Study First Posted: 2016-07-19
• Primary Completion: 2019-04-14
• Study Completion: 2019-04-14
• Status Verified: 2019-06
• Last Update Submitted: 2019-06-18
• Last Update Posted: 2019-06-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 58

Inclusion Criteria

• Patients 19 and older
• Referred for clinical DaTscan for possible PD
• Controls from the PPMI dataset.

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Exclusion Criteria

• Pregnant women
• Participants that cannot participate in MRI (metallic artifact or other contraindication(s) to MRI at 3T)

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Parkinson's disease from UAB	Diffusion Weighted Imaging (DWI)	MDS-UPDRS,Montreal Cognitive Assessment, PDQ-39, Diffusion Weighted Imaging (DWI), and neurological examination.

Primary Outcome Measures

Name	Time	Method
MRI and DAT scan: Accuracy of diagnosis of Parkinson's disease in a clinically relevant population	3-5 years	The study investigators will measure if MRI, specifically diffusion weighted imaging, can predict existence of Parkinson's disease. The study investigators will valuate if the derived MRI prediction matches or exceeds the accuracy of DATscan in detecting Parkinson's disease. The clinical/radiology reading of the DAT scan will determine the DAT scan diagnosis. The MRI scan diagnosis will be derived from statistical analysis of the full 5-dimensional brain DWI signal, as well as signals such as MRI T1 and resting fMRI signal. Methods of analysis will include using standard statistical techniques, the investigators published novel statistical techniques, and techniques such as Deep Learning and other artificial intelligence/learning algorithms.

Secondary Outcome Measures

Name	Time	Method
Can MRI profile risk for tremor and postural instability in PD	3-5 years	The study investigators will measure if MRI, specifically diffusion weighted imaging, can predict at disease onset which individuals with Parkinson's disease are at risk of developing significant postural instability and gait dysfunction.The MRI scan prediction will be derived from statistical analysis of the full 5-dimensional brain DWI signal, as well as signals such as MRI T1 and resting fMRI signal. Methods of analysis will include using standard statistical techniques, the investigators published novel statistical techniques, and techniques such as Deep Learning and other artificial intelligence/learning algorithms.

Trial Locations

Locations (1)

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States