| NCT ID | NCT05286736 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Minnesota |
| Condition | Parkinson |
| Study Type | OBSERVATIONAL |
| Enrollment | 50 participants |
| Start Date | 2021-03-01 |
| Primary Completion | 2026-07-09 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 50 participants in total. It began in 2021-03-01 with a primary completion date of 2026-07-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05286736 clinical trial?
This trial is open to participants of all sexes, aged 21 Years or older, up to 75 Years, studying Parkinson. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05286736 currently recruiting?
Yes, NCT05286736 is actively recruiting participants. Contact the research team at cmackinn@umn.edu for enrollment information.
Where is the NCT05286736 trial being conducted?
This trial is being conducted at Minneapolis, United States.
Who is sponsoring the NCT05286736 clinical trial?
NCT05286736 is sponsored by University of Minnesota. The trial plans to enroll 50 participants.
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