Clinical trial NCT04904068: Functional Neuroimaging in Parkinson's Disease
Official title: Imaging the Motor System in Parkinson's Disease
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Parkinson Disease
Healthy Aging
Lead sponsor: University of Delaware
Sponsor class: OTHER
First posted: 2021-05-27
Enrollment: 40
Sex: ALL
Minimum age (years): 45
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Open to local community as well as residents in DE or other nearby states willing to travel to the University of Delaware for the study.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Functional MRI activity during a motor task
timeFrame: Baseline
Secondary outcomes:
measure: Movement Disorder Society Unified Parkinson's Disease Rating Scale
timeFrame: Baseline
measure: Kinesia One
timeFrame: Baseline
measure: Timed Up and Go
timeFrame: Baseline
measure: 360-Degree Turn Test
timeFrame: Baseline
measure: Five Times Sit to Stand
timeFrame: Baseline
measure: The Modified Clinical Test of Sensory Interaction and Balance (mCTSIB)
timeFrame: Baseline
measure: 2-Minute Walking Test
timeFrame: Baseline.
measure: Purdue Pegboard Test
timeFrame: Baseline
measure: Grooved Pegboard
timeFrame: Baseline
measure: Montreal Cognitive Assessment Test
timeFrame: Baseline
measure: Brief Test of Attention
timeFrame: Baseline
measure: Beck Depression Inventory II
timeFrame: Baseline
measure: Parkinson's Disease Questionnaire (PDQ-39)
timeFrame: Baseline
measure: Schwab and England Activities of Daily Living Scale
timeFrame: Baseline
measure: Rapid Eye Movement Behavior Disorder Questionnaire
timeFrame: Baseline
measure: Epworth Sleepiness Scale
timeFrame: Baseline
measure: University of Pennsylvania Smell Identification Test
timeFrame: Baseline
Other outcomes:
Locations:
city: Newark
country: United States
facility: University of Delaware
state: Delaware
Study officials:
affiliation: University of Delaware
name: Roxana G Burciu, PhD
role: PRINCIPAL_INVESTIGATOR
References: