Neuroplasticity in Parkinson's Disease

NCT05286736 | Recruiting FDA Device

• 1 other identifier: NEUR-2019-28388
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this project is to increase our understanding of the early state and temporal evolution of neuroplastic changes in the cortex and subthalamic nucleus (STN) of people with PD, and the relationship of these changes to the emergence and expression of PD motor and non-motor signs. Neurophysiological biomarkers derived from this work may be important for the early detection and prediction of progression of disease. They can also provide the means to assess the efficacy of interventions designed to prevent or slow disease progression.

Conditions

Parkinson; Parkinson Disease

Keywords

Parkinson's

Outcome Measures

Primary Outcomes (10)

• Change in volume of Subthalamic Nucleus

  The volume of the subthalamic nucleus is assessed using MRI and reported in millimeters cubed (mm\^3).

  Baseline, 30-36 months

• Change in fractional Anisotropy of Subthalamic Nucleus

  Fractional anisotropy, measured using MRI, is a unit-less value between zero and one that describes the degree of anisotropy of water diffusion in a specified brain area. Higher values indicate a greater degree of anisotropy, while a score of zero indicates isotropic diffusion.

  Baseline, 30-36 months

• Change in cortico-STN Connectivity

  Cortico-Subthalamic nucleus connectivity is measured using MRI and reported as a z score (unitless).

  Baseline, 30-36 months

• Change in paired Associative Stimulation-Motor Evoked Potential (PAS-MEP)

  Motor evoked potential is measured as the amplitude of change in target muscle electrical activity following transcranial magnetic stimulation (TMS) and reported in units of millivolts (mV).

  Baseline, 30-36 months

• Change in Mattis Dementia Rating Scale 2 (DRS-2)

  The DRS-2 consists of 24 items, rated on a scale from 0 to 6. Item scores are combined into five subscales: attention (8 items), initiation/perseveration (11 items), construction (6 items), conceptualization ( 6 items), and memory (5 items). These five subscale scores are summed to calculate a total score ranging from from 0 to 144 points, with lower scores indicating worse performance due to dementia.

  Baseline, 30-36 months

• Change in Rey Complex Figure and Matrix Reasoning of the Wechsler Adult Intelligence Scale - IV

  Baseline, 30-36 months

• Change in Stroop Color Word Test

  Baseline, 30-36 months

• Change in Wisconsin Card Sorting Test

  Baseline, 30-36 months

• Change in Delis-Kaplan Executive Function System (D-KEFS) Verbal Fluency Subtest

  Baseline, 30-36 months

• Change in Brief Visuospatial Memory Test - Revised (BVMT-R)

  Baseline, 30-36 months

Study Arms (2)

Early (untreated) Parkinson's Disease

Diagnosis of idiopathic PD, as determined by a movement disorders neurologist in accordance with the PD Society Brain Bank diagnostic criteria.

Diagnostic Test: Neuroimaging; Diagnostic Test: Quantitative assessments

Healthy Controls

Age- and sex-matched healthy controls.

Diagnostic Test: Neuroimaging; Diagnostic Test: Quantitative assessments

Interventions

Neuroimaging DIAGNOSTIC_TEST

This project will use neuroimaging (7T MRI: structural, diffusion and rest-state functional MRI) and non-invasive brain stimulation (TMS: PAS. SAI) techniques to quantify structural and functional changes in brain function.

Early (untreated) Parkinson's Disease; Healthy Controls

Quantitative assessments DIAGNOSTIC_TEST

Quantitative assessments of motor function (gait, gait initiation, reactive balance, bradykinesia, repetitive alternating movements, rigidity, stop-signal reaction time), and neuropsychological function

Early (untreated) Parkinson's Disease; Healthy Controls

Eligibility Criteria

• Age: 21 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adults diagnosed with Parkinson's Disease (early diagnosis, currently untreated) and age- and sex-matched healthy controls

You may qualify if:

• Participants with PD
• Diagnosis of idiopathic PD, as determined by a movement disorders neurologist in accordance with the PD Society Brain Bank diagnostic criteria
• Not receiving levodopa or dopamine agonist to treat PD (at baseline)
• Able to ambulate independently without the use of an assistive device (e.g. cane) for 50 meters Healthy Controls
• Age- (+/- 3 years) and sex-matched to participants with PD
• Able to ambulate independently without the use of an assistive device (e.g. cane) for 50 meters

You may not qualify if:

• Dementia diagnosis and/or a University of California Brief Assessment of Capacity to Consent (UBACC) score and MacCAT-CR score indicating impaired capacity to consent
• History of musculoskeletal disorders that significant affect movement of lower or upper limbs as determined at the time of enrollment
• History of bipolar disorder, post-traumatic stress disorder or major depressive disorder
• Other significant neurological disorders that may affect participation or performance in the study
• Implanted DBS or other neurosurgeries to treat PD
• Pregnancy
• History of seizures, epilepsy, stroke, multiple sclerosis, or traumatic brain injury
• Recent history of frequent syncope (fainting) episodes in response to blood, emotional stress, or sensory triggers.
• Intracranial metallic or magnetic devices (e.g. cochlear implant, deep brain stimulator)
• Pacemaker or any implanted device
• History of surgery on blood vessels, brain, or heart
• Unexplained, recurring headaches or concussion within the last six months
• Severe hearing impairment

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

RECRUITING

MeSH Terms

Conditions

Parkinson Disease

Interventions

Neuroimaging

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Neurological; Investigative Techniques

Central Study Contacts

Colum MacKinnon, PhD

CONTACT

612-625-5993; cmackinn@umn.edu

Madison Aasen

CONTACT

612-505-8325; aasen056@umn.edu

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2022
• First Posted: March 18, 2022
• Study Start: March 1, 2021
• Primary Completion (Estimated): July 9, 2026
• Study Completion (Estimated): November 9, 2028
• Last Updated: August 8, 2025

Record last verified: 2025-08

Locations

US (1)