Diagnosis of PD and PD Progression Using DWI

NCT02837172 | Completed

• 1 other identifier: K23NS083620
• Study Type: observational
• Target: 58
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson's Disease

Outcome Measures

Primary Outcomes (1)

• MRI and DAT scan: Accuracy of diagnosis of Parkinson's disease in a clinically relevant population

  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.

  3-5 years

Secondary Outcomes (1)

• Can MRI profile risk for tremor and postural instability in PD

  3-5 years

Study Arms (3)

Parkinson's disease from UAB

MDS-UPDRS,Montreal Cognitive Assessment, PDQ-39, Diffusion Weighted Imaging (DWI), and neurological examination.

Other: Diffusion Weighted Imaging (DWI)

Parkinson's disease from PPMI dataset

Obtain retrospective and prospective de-identified data from the The Parkinson's Progression Markers Initiative (PPMI) dataset on Parkinson's disease (PD) subjects that have the following characteristics: within 2 years of diagnosis, positive DaTscan, and not (at study entry) on any PD related medication.

Controls from PPMI dataset

Obtain retrospective and prospective de-identified DTI imaging and data from the PPMI dataset

Interventions

Diffusion Weighted Imaging (DWI) OTHER

MDS-UPDRS,Montreal Cognitive Assessment, PDQ-39, DTI imaging (MRI), and neurological examination. Expert evaluation: Record review, PD Medical History and PD Family History Form, the Montreal Cognitive Assessment, PDQ-39. standard, full, neurological examination, and MDS-UPDRS

Parkinson's disease from UAB

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

100 PD subjects with DaTscan, and 210 (140 PD/70 control) from the PPMI dataset

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Frank Skidmore, MD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Neurology

Study Record Dates

• First Submitted: April 29, 2016
• First Posted: July 19, 2016
• Study Start: September 25, 2014
• Primary Completion: April 14, 2019
• Study Completion: April 14, 2019
• Last Updated: June 19, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will share

Locations

US (1)