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Neuroplasticity in Parkinson's Disease

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ClinicalTrials.gov Identifier: NCT05286736
Recruitment Status : Recruiting
First Posted : March 18, 2022
Last Update Posted : March 22, 2023
Sponsor:
Information provided by (Responsible Party):
University of Minnesota

Study Description
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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.

Condition or disease Intervention/treatment
Parkinson Parkinson Disease Diagnostic Test: Neuroimaging Diagnostic Test: Quantitative assessments

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 Design
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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Plasticity of Motor Systems in Early Stage Parkinson's Disease
Actual Study Start Date : March 1, 2021
Estimated Primary Completion Date : July 9, 2025
Estimated Study Completion Date : November 9, 2028

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  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 ]

Eligibility Criteria
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Ages Eligible for Study:   21 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
Criteria

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
  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05286736


Contacts
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Contact: Colum MacKinnon, PhD 612-625-5993 cmackinn@umn.edu
Contact: Joshua De Kam 612-626-8052 jadekam@umn.edu

Locations
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United States, Minnesota
University of Minnesota Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Joshua De Kam    612-626-8052    jadekam@umn.edu   
Sponsors and Collaborators
University of Minnesota
More Information
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Responsible Party: University of Minnesota
ClinicalTrials.gov Identifier: NCT05286736    
Other Study ID Numbers: NEUR-2019-28388
First Posted: March 18, 2022    Key Record Dates
Last Update Posted: March 22, 2023
Last Verified: March 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by University of Minnesota:
Parkinson's
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Movement Disorders
Synucleinopathies
Neurodegenerative Diseases