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Completed

NCT Number: NCT04904068

Functional Neuroimaging 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.

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Key information

Conditions

Parkinson Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Healthy Aging Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinsonian Disorders Synucleinopathies

Age range

45 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Delaware

Newark, Delaware, 19713, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Functional MRI activity during a motor task

    Time frame: Baseline

    Functional MRI activity during isolated/coordinated movements of the upper and lower limbs

Secondary outcomes

  1. Movement Disorder Society Unified Parkinson's Disease Rating Scale

    Time frame: Baseline

    Only the motor section will be scored. Maximum points: 84 (the higher the score, the more severe the motor symptoms)

  2. Kinesia One

    Time frame: Baseline

    Instrumented measures of motor dysfunction in Parkinson's disease. Maximum points: 72 (the higher the score, the more severe the motor symptoms)

  3. Timed Up and Go

    Time frame: Baseline

    Mobility test (instrumented). Measures: duration (s), lean angle during sit/stand (degrees), turning duration (s) and turning angle (degrees)

  4. 360-Degree Turn Test

    Time frame: Baseline

    Instrumented test measuring dynamic balance. Measures: turning angle (degrees), turning duration (s), turning velocity (degrees/s)

  5. Five Times Sit to Stand

    Time frame: 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)

  6. The Modified Clinical Test of Sensory Interaction and Balance (mCTSIB)

    Time frame: 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)

  7. 2-Minute Walking Test

    Time frame: 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).

  8. Purdue Pegboard Test

    Time frame: Baseline

    Test measuring dexterity by counting the number of pegs placed on the pegboard during a given time.

  9. Grooved Pegboard

    Time frame: Baseline

    Test measuring dexterity by counting how long it takes to place a given number of pegs on the pegboard.

  10. Montreal Cognitive Assessment Test

    Time frame: Baseline

    Test measuring global cognitive function. Maximum points: 30 (the higher the score, the better the cognitive function)

  11. Brief Test of Attention

    Time frame: 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)

  12. Beck Depression Inventory II

    Time frame: Baseline

    Questionnaire measuring depression. Maximum points: 63 (high score indicates depression)

  13. Parkinson's Disease Questionnaire (PDQ-39)

    Time frame: Baseline

    Questionnaire measure health-related quality of life. Eight dimensions ranging from 0-100 (the higher the score, the worse the quality of life)

  14. Schwab and England Activities of Daily Living Scale

    Time frame: 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

  15. Rapid Eye Movement Behavior Disorder Questionnaire

    Time frame: Baseline

    Questionnaire measuring sleep behavior. Maximum points: 13 (a high score is indicative of RBD sleep disorder)

  16. Epworth Sleepiness Scale

    Time frame: Baseline

    Questionnaire measuring sleepiness. Maximum points: 24 (high score indicates sleepiness)

  17. University of Pennsylvania Smell Identification Test

    Time frame: Baseline

    Test measuring sense of smell. Maximum points: 40 (the higher the score, the more normal the smell)

Sponsors and collaborators

Lead sponsor

University of Delaware

Other

Registry information

Official study title

Imaging the Motor System in Parkinson's Disease

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
May 27, 2021
Registry last updated
May 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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