Functional Neuroimaging in Parkinson's Disease

Active, not recruiting

• Conditions: Parkinson Disease; Healthy Aging

• Registration Number: NCT04904068
• Lead Sponsor: University of Delaware

Brief Summary

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.

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 Timeline

• Study Start: 2020-09-15
• Study First Submitted: 2021-02-18
• Study First Submitted QC: 2021-05-21
• Study First Posted: 2021-05-27
• Primary Completion: 2022-11-02
• Status Verified: 2024-05
• Last Update Submitted: 2025-04-02
• Last Update Posted: 2025-04-06
• Study Completion: 2025-11-02

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Functional MRI activity during a motor task	Baseline	Functional MRI activity during isolated/coordinated movements of the upper and lower limbs

Secondary Outcome Measures

Name	Time	Method
Five Times Sit to Stand	Baseline	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)
The Modified Clinical Test of Sensory Interaction and Balance (mCTSIB)	Baseline	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)
Purdue Pegboard Test	Baseline	Test measuring dexterity by counting the number of pegs placed on the pegboard during a given time.
Parkinson's Disease Questionnaire (PDQ-39)	Baseline	Questionnaire measure health-related quality of life. Eight dimensions ranging from 0-100 (the higher the score, the worse the quality of life)
Kinesia One	Baseline	Instrumented measures of motor dysfunction in Parkinson's disease. Maximum points: 72 (the higher the score, the more severe the motor symptoms)
Movement Disorder Society Unified Parkinson's Disease Rating Scale	Baseline	Only the motor section will be scored. Maximum points: 84 (the higher the score, the more severe the motor symptoms)
Schwab and England Activities of Daily Living Scale	Baseline	Questionnaire on ability to complete daily task. 10% increments with 100% meaning an individual is completely independent when it comes to completing daily activities
Timed Up and Go	Baseline	Mobility test (instrumented). Measures: duration (s), lean angle during sit/stand (degrees), turning duration (s) and turning angle (degrees)
360-Degree Turn Test	Baseline	Instrumented test measuring dynamic balance. Measures: turning angle (degrees), turning duration (s), turning velocity (degrees/s)
2-Minute Walking Test	Baseline.	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).
Brief Test of Attention	Baseline	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)
University of Pennsylvania Smell Identification Test	Baseline	Test measuring sense of smell. Maximum points: 40 (the higher the score, the more normal the smell)
Grooved Pegboard	Baseline	Test measuring dexterity by counting how long it takes to place a given number of pegs on the pegboard.
Montreal Cognitive Assessment Test	Baseline	Test measuring global cognitive function. Maximum points: 30 (the higher the score, the better the cognitive function)
Beck Depression Inventory II	Baseline	Questionnaire measuring depression. Maximum points: 63 (high score indicates depression)
Rapid Eye Movement Behavior Disorder Questionnaire	Baseline	Questionnaire measuring sleep behavior. Maximum points: 13 (a high score is indicative of RBD sleep disorder)
Epworth Sleepiness Scale	Baseline	Questionnaire measuring sleepiness. Maximum points: 24 (high score indicates sleepiness)

Trial Locations

Locations (1)

University of Delaware; 🇺🇸 Newark, Delaware, United States