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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04904068
Other study ID # 1407867
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date September 15, 2020
Est. completion date November 2, 2024

Study information

Verified date May 2024
Source University of Delaware
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 40
Est. completion date November 2, 2024
Est. primary completion date November 2, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 45 Years to 85 Years
Eligibility 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


Related Conditions & MeSH terms


Locations

Country Name City State
United States University of Delaware Newark Delaware

Sponsors (1)

Lead Sponsor Collaborator
University of Delaware

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Functional MRI activity during a motor task Functional MRI activity during isolated/coordinated movements of the upper and lower limbs Baseline
Secondary 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
Secondary 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
Secondary Timed Up and Go Mobility test (instrumented). Measures: duration (s), lean angle during sit/stand (degrees), turning duration (s) and turning angle (degrees) Baseline
Secondary 360-Degree Turn Test Instrumented test measuring dynamic balance. Measures: turning angle (degrees), turning duration (s), turning velocity (degrees/s) Baseline
Secondary 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
Secondary 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
Secondary 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.
Secondary Purdue Pegboard Test Test measuring dexterity by counting the number of pegs placed on the pegboard during a given time. Baseline
Secondary Grooved Pegboard Test measuring dexterity by counting how long it takes to place a given number of pegs on the pegboard. Baseline
Secondary Montreal Cognitive Assessment Test Test measuring global cognitive function. Maximum points: 30 (the higher the score, the better the cognitive function) Baseline
Secondary 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
Secondary Beck Depression Inventory II Questionnaire measuring depression. Maximum points: 63 (high score indicates depression) Baseline
Secondary 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
Secondary 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
Secondary Rapid Eye Movement Behavior Disorder Questionnaire Questionnaire measuring sleep behavior. Maximum points: 13 (a high score is indicative of RBD sleep disorder) Baseline
Secondary Epworth Sleepiness Scale Questionnaire measuring sleepiness. Maximum points: 24 (high score indicates sleepiness) Baseline
Secondary University of Pennsylvania Smell Identification Test Test measuring sense of smell. Maximum points: 40 (the higher the score, the more normal the smell) Baseline
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