Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT05286736

Neuroplasticity in 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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

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

Age range

21 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Minnesota

Minneapolis, Minnesota, 55455, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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

Primary outcomes

  1. 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).

  2. 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.

  3. 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).

  4. 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).

  5. 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.

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

    Time frame: Baseline, 30-36 months

  7. Change in Stroop Color Word Test

    Time frame: Baseline, 30-36 months

  8. Change in Wisconsin Card Sorting Test

    Time frame: Baseline, 30-36 months

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

    Time frame: Baseline, 30-36 months

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

    Time frame: Baseline, 30-36 months

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Registry information

Official study title

Plasticity of Motor Systems in Early Stage Parkinson's Disease

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Mar 18, 2022
Registry last updated
Jul 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.