NCT04904068

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 15, 2020

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

February 18, 2021

Completed
3 months until next milestone

First Posted

Study publicly available on registry

May 27, 2021

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2023

Completed
Last Updated

May 6, 2026

Status Verified

April 1, 2026

Enrollment Period

3 years

First QC Date

February 18, 2021

Last Update Submit

April 30, 2026

Conditions

Parkinson DiseaseHealthy Aging

Outcome Measures

Primary Outcomes (1)

  • Functional MRI activity during a motor task

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

    Baseline

Secondary Outcomes (17)

  • Movement Disorder Society Unified Parkinson's Disease Rating Scale

    Baseline

  • Kinesia One

    Baseline

  • Timed Up and Go

    Baseline

  • 360-Degree Turn Test

    Baseline

  • Five Times Sit to Stand

    Baseline

  • +12 more secondary outcomes

Study Arms (2)

Parkinson's disease

Individuals with a clinical diagnosis of Parkinson's disease.

Healthy

Healthy individuals with no known neurological disorders.

Eligibility Criteria

Age45 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Delaware

Newark, Delaware, 19713, United States

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Officials

  • Roxana G Burciu, PhD

    University of Delaware

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

February 18, 2021

First Posted

May 27, 2021

Study Start

September 15, 2020

Primary Completion

August 31, 2023

Study Completion

August 31, 2023

Last Updated

May 6, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)