Neuroplasticity in Parkinson's Disease (NCT05286736) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Neuroplasticity in Parkinson's Disease
United States50 participantsStarted 2021-03-01
Plain-language 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.
Who can participate
Age range
21 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in volume of Subthalamic Nucleus
Timeframe: Baseline, 30-36 months
2
Change in fractional Anisotropy of Subthalamic Nucleus
Timeframe: Baseline, 30-36 months
3
Change in cortico-STN Connectivity
Timeframe: Baseline, 30-36 months
4
Change in paired Associative Stimulation-Motor Evoked Potential (PAS-MEP)
Timeframe: Baseline, 30-36 months
5
Change in Mattis Dementia Rating Scale 2 (DRS-2)
Timeframe: Baseline, 30-36 months
6
Change in Rey Complex Figure and Matrix Reasoning of the Wechsler Adult Intelligence Scale - IV