Functional Neuroimaging in Parkinson's Disease

Parkinson Disease Clinical Trial

Official title:

Imaging the Motor System in Parkinson's Disease

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04904068
• Other study ID #: 1407867
• Status: Active, not recruiting
• 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
• 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

Related Conditions & MeSH terms

• Healthy Aging
• Parkinson Disease

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