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Neuroplasticity in Parkinson's Disease

NCT05286736 · University of Minnesota
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Official title
Plasticity of Motor Systems in Early Stage Parkinson's Disease
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.
Eligibility 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 * 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 design
Enrollment target: 50 participants
Age groups: adult, older_adult
Timeline
Starts: 2021-03-01
Estimated completion: 2028-11-09
Last updated: 2025-08-08
Interventions
Diagnostic Test: NeuroimagingDiagnostic Test: Quantitative assessments
Primary outcomes
  • Change in volume of Subthalamic Nucleus (Baseline, 30-36 months)
  • Change in fractional Anisotropy of Subthalamic Nucleus (Baseline, 30-36 months)
  • Change in cortico-STN Connectivity (Baseline, 30-36 months)
Sponsor
University of Minnesota · other
Contacts & investigators
ContactColum MacKinnon, PhD · contact · cmackinn@umn.edu · 612-625-5993
ContactMadison Aasen · contact · aasen056@umn.edu · 612-505-8325
All locations (1)
University of MinnesotaRecruiting
Minneapolis, Minnesota, United States
Neuroplasticity in Parkinson's Disease · TrialPath