Functional Neuroimaging in Parkinson's Disease

Imaging the Motor System in Parkinson's Disease

The study uses magnetic resonance imaging (MRI) to better understand changes in the brain underlying motor symptoms affecting upper and lower limbs in Parkinson's disease.

Study Overview

• Status: Completed
• Conditions: Parkinson Disease; Healthy Aging

Detailed Description

There is a tremendous need to improve the understanding of the pathophysiology underlying motor symptoms in Parkinson's disease in order to optimize existing treatment options/develop new therapies. This study seeks to further the understanding of impaired movement in Parkinson's disease by examining brain changes and how these relate to changes in motor behavior.

The study uses magnetic resonance imaging (MRI), a noninvasive imaging technique that does not include X-rays. MRI will assess brain activity in response to simple and coordinated movements of the upper and lower limbs that participants have to perform inside the MRI scanner. Motor and cognitive function outside the scanner using various clinical and behavioral tests will also be assessed. The study includes 1 visit to the University of Delaware.

• Study Type: Observational
• Enrollment (Actual): 40

Contacts and Locations

Study Locations

• United States
  • Delaware
    • Newark, Delaware, United States, 19713
      • University of Delaware

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

Open to local community as well as residents in DE or other nearby states willing to travel to the University of Delaware for the study.

Description

Inclusion Criteria:

• A clinical diagnosis of Parkinson's disease
• No neurological disorders if interested in participating as a control participant
• Must be capable of providing informed consent
• Must be eligible to receive a brain MRI

Exclusion Criteria:

• A secondary movement disorder diagnosis in addition to Parkinson's disease
• Dementia
• Medical conditions that may make one ineligible for receiving a brain MRI
• Inability to provide informed consent
• Control/healthy group: neurological disorders
• Control/healthy group: cannot walk without an assistive device/mobility problems

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Parkinson's disease; Individuals with a clinical diagnosis of Parkinson's disease.
Healthy; Healthy individuals with no known neurological disorders.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional MRI activity during a motor task	Functional MRI activity during isolated/coordinated movements of the upper and lower limbs	Baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Movement Disorder Society Unified Parkinson's Disease Rating Scale	Only the motor section will be scored. Maximum points: 84 (the higher the score, the more severe the motor symptoms)	Baseline
Kinesia One	Instrumented measures of motor dysfunction in Parkinson's disease. Maximum points: 72 (the higher the score, the more severe the motor symptoms)	Baseline
Timed Up and Go	Mobility test (instrumented). Measures: duration (s), lean angle during sit/stand (degrees), turning duration (s) and turning angle (degrees)	Baseline
360-Degree Turn Test	Instrumented test measuring dynamic balance. Measures: turning angle (degrees), turning duration (s), turning velocity (degrees/s)	Baseline
Five Times Sit to Stand	Instrumented test measuring ability to perform transitional movements (i.e., get up from a chair). Measures: Duration (s), duration of the different phases (sitting/standing) (s), lean angle during the two phases (sitting/standing) (degrees)	Baseline
The Modified Clinical Test of Sensory Interaction and Balance (mCTSIB)	Instrumented test assessing balance under different test conditions (eyes open/closed on firm/foam surface). Measures of postural sway: sway area (m^2/s^4), jerk (m^2/s^5), mean velocity (m/s), path length (m/s^2)	Baseline
2-Minute Walking Test	Instrument test assessing gait under three different conditions: 1) self-selected/normal speed, 2) self-selective/normal speed + cognitive task, 3) fast speed. Measures calculated for each condition/side of body: cadence (steps/min), double support (%GCT), gait cycle duration (s), gait speed (m/s), lateral step variability (cm), toe off angle (degrees), foot strike angle (degrees), turn velocity (degrees/s), upper limb range of motion (degrees), arm swing velocity (degrees/s).	Baseline.
Purdue Pegboard Test	Test measuring dexterity by counting the number of pegs placed on the pegboard during a given time.	Baseline
Grooved Pegboard	Test measuring dexterity by counting how long it takes to place a given number of pegs on the pegboard.	Baseline
Montreal Cognitive Assessment Test	Test measuring global cognitive function. Maximum points: 30 (the higher the score, the better the cognitive function)	Baseline
Brief Test of Attention	Test measuring attention. Two sections are used that evaluate attention during reading of lists of letters and numbers. Maximum points across the two sections: 20 (the higher the score, the better the attention)	Baseline
Beck Depression Inventory II	Questionnaire measuring depression. Maximum points: 63 (high score indicates depression)	Baseline
Parkinson's Disease Questionnaire (PDQ-39)	Questionnaire measure health-related quality of life. Eight dimensions ranging from 0-100 (the higher the score, the worse the quality of life)	Baseline
Schwab and England Activities of Daily Living Scale	Questionnaire on ability to complete daily task. 10% increments with 100% meaning an individual is completely independent when it comes to completing daily activities	Baseline
Rapid Eye Movement Behavior Disorder Questionnaire	Questionnaire measuring sleep behavior. Maximum points: 13 (a high score is indicative of RBD sleep disorder)	Baseline
Epworth Sleepiness Scale	Questionnaire measuring sleepiness. Maximum points: 24 (high score indicates sleepiness)	Baseline
University of Pennsylvania Smell Identification Test	Test measuring sense of smell. Maximum points: 40 (the higher the score, the more normal the smell)	Baseline

Collaborators and Investigators

• Sponsor: University of Delaware
• Investigators: Principal Investigator: Roxana G Burciu, PhD, University of Delaware

Study record dates

Study Major Dates

• Study Start (Actual): September 15, 2020
• Primary Completion (Actual): August 31, 2023
• Study Completion (Actual): August 31, 2023

Study Registration Dates

• First Submitted: February 18, 2021
• First Submitted That Met QC Criteria: May 21, 2021
• First Posted (Actual): May 27, 2021

Study Record Updates

• Last Update Posted (Actual): May 6, 2026
• Last Update Submitted That Met QC Criteria: April 30, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Synucleinopathies; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurodegenerative Diseases; Movement Disorders; Parkinsonian Disorders; Basal Ganglia Diseases; Parkinson Disease
• Other Study ID Numbers: 1407867

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No