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Functional Neuroimaging in Parkinson's Disease

Imaging the Motor System in Parkinson's Disease

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04904068
Enrollment
40
Registered
2021-05-27
Start date
2020-09-15
Completion date
2023-08-31
Last updated
2026-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Aging, Parkinson Disease

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.

Interventions

None listed

Sponsors

University of Delaware
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
45 Years to 85 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Functional MRI activity during a motor taskBaselineFunctional MRI activity during isolated/coordinated movements of the upper and lower limbs

Secondary

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

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORRoxana G Burciu, PhD

University of Delaware

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 7, 2026