Neuroplasticity in Parkinson's Disease

July 10, 2026 updated by: University of Minnesota

Plasticity of Motor Systems in Early Stage Parkinson's Disease

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This project will use neuroimaging (7T MRI: structural, diffusion and rest-state functional MRI), from Dr. Noam Harel's protocol IRB# STUDY00008096, and non-invasive brain stimulation (TMS: PAS. SAI) techniques to quantify structural and functional changes in brain function. The TMS experiment will use a Magstim Bistimn 2002 transcranial magnetic stimulation (TMS) unit and standard figure-of-eight coil (70 mm diameter) to deliver stimulation on the surface of the scalp. Stimulation will be delivered using either a single pulse or with a paired-pulse protocol (two stimuli, through the same TMS coil at inter-stimulus intervals of 50 or 80 ms). All surface EMG signals will be pre-amplified within the sensor and sent wirelessly via blue-tooth connection to a Delsys data collection system. Quantitative assessments of motor function (gait, gait initiation, reactive balance, bradykinesia, repetitive alternating movements, rigidity, stop-signal reaction time), and neuropsychological function will used to assess behavioral status at baseline and 30-36 months later.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • University of Minnesota

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

21 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Additional exclusion criteria for TMS experiments (note that individuals who are excluded from the TMS experiment still have the opportunity to participate in the other data collection sessions):

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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
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.
Diagnostic test: Quantitative assessments
Quantitative assessments of motor function (gait, gait initiation, reactive balance, bradykinesia, repetitive alternating movements, rigidity, stop-signal reaction time), and neuropsychological function
Healthy Controls
Age- and sex-matched healthy controls.
Diagnostic test: Neuroimaging
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.
Diagnostic test: Quantitative assessments
Quantitative assessments of motor function (gait, gait initiation, reactive balance, bradykinesia, repetitive alternating movements, rigidity, stop-signal reaction time), and neuropsychological function

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in volume of Subthalamic Nucleus
Time Frame: Baseline, 30-36 months
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
Time Frame: Baseline, 30-36 months
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
Time Frame: Baseline, 30-36 months
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)
Time Frame: Baseline, 30-36 months
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)
Time Frame: Baseline, 30-36 months
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
Time Frame: Baseline, 30-36 months
Baseline, 30-36 months
Change in Stroop Color Word Test
Time Frame: Baseline, 30-36 months
Baseline, 30-36 months
Change in Wisconsin Card Sorting Test
Time Frame: Baseline, 30-36 months
Baseline, 30-36 months
Change in Delis-Kaplan Executive Function System (D-KEFS) Verbal Fluency Subtest
Time Frame: Baseline, 30-36 months
Baseline, 30-36 months
Change in Brief Visuospatial Memory Test - Revised (BVMT-R)
Time Frame: Baseline, 30-36 months
Baseline, 30-36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Minnesota

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2021

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 31, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 31, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 17, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 17, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 18, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 14, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 10, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NEUR-2019-28388

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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