Neuroplasticity in Parkinson's Disease
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age21-75
SponsorUniversity of Minnesota
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Trial population
Adults diagnosed with Parkinson's Disease (early diagnosis, currently untreated) and age- and sex-matched healthy controls
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
Neuroimaging
Diagnostic testThis 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 testQuantitative assessments of motor function (gait, gait initiation, reactive balance, bradykinesia, repetitive alternating movements, rigidity, stop-signal reaction time), and neuropsychological function
Treatment groups
50 Participants
are divided into 2 treatment groupsGroup A: Early (untreated) Parkinson's Disease2 interventions
Group B: Healthy Controls2 interventions
Trial outcomes
Primary outcomes
1
Change in volume of Subthalamic Nucleus
The volume of the subthalamic nucleus is assessed using MRI and reported in millimeters cubed (mm\^3).
Time frame
Baseline, 30-36 months2
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.
Time frame
Baseline, 30-36 months3
Change in cortico-STN Connectivity
Cortico-Subthalamic nucleus connectivity is measured using MRI and reported as a z score (unitless).
Time frame
Baseline, 30-36 months4
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).
Time frame
Baseline, 30-36 monthsSponsors and contacts
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Source ClinicalTrials.gov