Parkinson DiseaseNCT04904068
Functional Neuroimaging in Parkinson's Disease
An observational study of Parkinson Disease and Healthy Aging, run by University of Delaware at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 45 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Parkinson Disease, Healthy Aging
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Sep 2020to 31 Aug 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Imaging the Motor System 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.
Read the 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.
- Conditions
- Parkinson Disease, Healthy Aging
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Parkinson's disease | Individuals with a clinical diagnosis of Parkinson's disease. | |
| Healthy | Healthy individuals with no known neurological disorders. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional MRI activity during a motor task
Functional MRI activity during isolated/coordinated movements of the upper and lower limbs
Measured: Baseline
Secondary outcomes (17)
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)
Measured: Baseline
Kinesia One
Instrumented measures of motor dysfunction in Parkinson's disease. Maximum points: 72 (the higher the score, the more severe the motor symptoms)
Measured: Baseline
Timed Up and Go
Mobility test (instrumented). Measures: duration (s), lean angle during sit/stand (degrees), turning duration (s) and turning angle (degrees)
Measured: Baseline
360-Degree Turn Test
Instrumented test measuring dynamic balance. Measures: turning angle (degrees), turning duration (s), turning velocity (degrees/s)
Measured: Baseline
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)
Measured: Baseline
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)
Measured: Baseline
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).
Measured: Baseline.
Purdue Pegboard Test
Test measuring dexterity by counting the number of pegs placed on the pegboard during a given time.
Measured: Baseline
Grooved Pegboard
Test measuring dexterity by counting how long it takes to place a given number of pegs on the pegboard.
Measured: Baseline
Montreal Cognitive Assessment Test
Test measuring global cognitive function. Maximum points: 30 (the higher the score, the better the cognitive function)
Measured: Baseline
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)
Measured: Baseline
Beck Depression Inventory II
Questionnaire measuring depression. Maximum points: 63 (high score indicates depression)
Measured: Baseline
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)
Measured: Baseline
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
Measured: Baseline
Rapid Eye Movement Behavior Disorder Questionnaire
Questionnaire measuring sleep behavior. Maximum points: 13 (a high score is indicative of RBD sleep disorder)
Measured: Baseline
Epworth Sleepiness Scale
Questionnaire measuring sleepiness. Maximum points: 24 (high score indicates sleepiness)
Measured: Baseline
University of Pennsylvania Smell Identification Test
Test measuring sense of smell. Maximum points: 40 (the higher the score, the more normal the smell)
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2021
- Study start15 Sep 2020
- Primary completion31 Aug 2023
- Study completion31 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Delaware
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Roxana Burciu, University of Delaware
- Investigators
- Roxana G Burciu, PhD, Principal investigator, University of Delaware
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04904068
- Sponsor's protocol ID
- 1407867
- Status last verified
- Apr 2026
- First submitted
- 18 Feb 2021
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Imaging the Motor System in Parkinson's Disease
- ClinicalTrials.gov ID
- NCT04904068
- Acronym / sponsor ID
- 1407867
- Conditions
- Parkinson Disease, Healthy Aging
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of DelawareUniversity, hospital or other
- Study start
- 15 Sep 2020 (actual)
- Primary completion
- 31 Aug 2023 (actual)
- Study completion
- 31 Aug 2023 (actual)
- First posted
- 27 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Parkinson's disease | – | –Individuals with a clinical diagnosis of Parkinson's disease. |
| Healthy | – | –Healthy individuals with no known neurological disorders. |
Who may qualify
- Ages
- 45 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Functional MRI activity during a motor task
Time frame: Baseline
Functional MRI activity during isolated/coordinated movements of the upper and lower limbs
17 secondary outcomes
Movement Disorder Society Unified Parkinson's Disease Rating Scale
Time frame: Baseline
Kinesia One
Time frame: Baseline
Timed Up and Go
Time frame: Baseline
360-Degree Turn Test
Time frame: Baseline
Five Times Sit to Stand
Time frame: Baseline
The Modified Clinical Test of Sensory Interaction and Balance (mCTSIB)
Time frame: Baseline
2-Minute Walking Test
Time frame: Baseline.
Purdue Pegboard Test
Time frame: Baseline
Grooved Pegboard
Time frame: Baseline
Montreal Cognitive Assessment Test
Time frame: Baseline
Brief Test of Attention
Time frame: Baseline
Beck Depression Inventory II
Time frame: Baseline
Parkinson's Disease Questionnaire (PDQ-39)
Time frame: Baseline
Schwab and England Activities of Daily Living Scale
Time frame: Baseline
Rapid Eye Movement Behavior Disorder Questionnaire
Time frame: Baseline
Epworth Sleepiness Scale
Time frame: Baseline
University of Pennsylvania Smell Identification Test
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roxana G Burciu, PhD principal investigator
University of Delaware
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson Disease and Healthy Aging, run by University of Delaware at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional MRI activity during a motor task (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2026.