Understanding neuroplasticity changes in Parkinson's disease
Plasticity of Motor Systems in Early Stage Parkinson's Disease
This study is trying to see how changes in the brain of people with Parkinson's disease affect their movement and other symptoms over time.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 21 Years to 75 Years |
| Sex | All |
| Sponsor | University of Minnesota Academic / other |
| Locations | 1 site (Minneapolis, Minnesota) |
| Trial ID | NCT05286736 on ClinicalTrials.gov |
What this trial studies
This project aims to enhance our understanding of neuroplastic changes in the cortex and subthalamic nucleus of individuals with Parkinson's disease (PD) and how these changes relate to motor and non-motor symptoms. Utilizing advanced neuroimaging techniques such as 7T MRI and non-invasive brain stimulation methods like TMS, the study will quantify structural and functional brain changes. Participants will undergo quantitative assessments of motor and neuropsychological functions at baseline and again after 30-36 months to evaluate disease progression and intervention efficacy.
Who should consider this trial
Good fit: Ideal candidates include individuals diagnosed with idiopathic Parkinson's disease who are not currently receiving levodopa or dopamine agonist treatment.
Not a fit: Patients with dementia or significant neurological disorders, as well as those with a history of severe mood disorders, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved early detection and monitoring of Parkinson's disease progression.
How similar studies have performed: Other studies have shown promise in using neuroimaging and neurostimulation techniques to understand neuroplasticity in neurological conditions, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Minneapolis, Minnesota
- University of Minnesota — Minneapolis, Minnesota, United States (Recruiting)
Study contacts
- Study coordinator: Colum MacKinnon, PhD
- Email: cmackinn@umn.edu
- Phone: 612-625-5993
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.