Identify motor plasticity affecting walking
- Trial ID
- NCT05286736
- Official Title
- Plasticity of Motor Systems in Early Stage Parkinson's Disease
- Goal
- Identify motor plasticity affecting walking
- Status
- RECRUITING
- Sponsor
- University of Minnesota
- Study Type
- OBSERVATIONAL
- Enrollment
- 50 participants
- Conditions
- Parkinson, Parkinson Disease
- Interventions
- Neuroimaging, Quantitative assessments
Summary For Families
Goal: Learn how motor brain circuits change in early Parkinson's, so researchers can tell whether the brain is compensating or losing plasticity in ways that affect symptoms. Approach: Participants have MRI-based neuroimaging and detailed movement testing, and some take part in transcranial magnetic stimulation sessions that send brief magnetic pulses to the motor cortex to measure how excitable and adaptable those motor pathways are, and because participants are not on levodopa or dopamine agonists at baseline, the study looks at the untreated brain's motor responses with no interaction from those drugs. Eligibility: Adults 21 to 75 with idiopathic Parkinson's diagnosed by a movement disorders neurologist who can walk 50 meters unaided, plus age- and sex-matched healthy controls. People with dementia, major psychiatric or other neurologic conditions, implanted brain or cardiac devices, pregnancy, or seizure risk are excluded, and some people excluded from the TMS portion can still join the other testing.
Locations
- University of Minnesota, Minneapolis, Minnesota, United States
Frequently Asked Questions
- What is this trial testing?
- This trial is studying Neuroimaging. Goal: Learn how motor brain circuits change in early Parkinson's, so researchers can tell whether the brain is compensating or losing plasticity in ways that affect symptoms. Approach: Participants have MRI-based neuroimaging and detailed movement testing, and some take part in transcranial magnetic stimulation sessions that send brief magnetic pulses to the motor cortex to measure how excitable and adaptable those motor pathways are, and because participants are not on levodopa or dopamine agonists at baseline, the study looks at the untreated brain's motor responses with no interaction from those drugs. Eligibility: Adults 21 to 75 with idiopathic Parkinson's diagnosed by a movement disorders neurologist who can walk 50 meters unaided, plus age- and sex-matched healthy controls. People with dementia, major psychiatric or other neurologic conditions, implanted brain or cardiac devices, pregnancy, or seizure risk are excluded, and some people excluded from the TMS portion can still join the other testing.
- Who can participate?
- Participants must be between 21 Years and 75 Years.
- Where is this trial located?
- This trial is recruiting at 1 location.
- Does it cost anything to join?
- No. There is no cost to participate. Study-related care and treatment are provided at no charge.
- How long does the trial last?
- This trial is estimated to last approximately 5 years and 4 months.
- Will I get the real drug or a placebo?
- It depends on the trial design. Some Parkinson's trials are placebo controlled, meaning a portion of participants get an inactive comparison while others get the experimental treatment. Some use crossover designs so everyone eventually receives the active treatment at some point. Observational trials do not use a placebo at all because they are not testing a new treatment. The consent form for any specific trial spells out the design and your odds of being assigned to placebo before you enroll.
- How often will I need to visit the study site?
- Visit frequency varies by trial. Many Parkinson's studies require an in person visit every 4 to 12 weeks during the active treatment phase, with shorter or longer gaps depending on the design. The site coordinator can give you the full visit schedule before you sign anything, so you know what the time commitment looks like.
- Can I leave the trial if I change my mind?
- Yes. You can withdraw from any clinical trial at any time, for any reason, without affecting your standard medical care. Trials are voluntary by law. The team may ask if you are willing to do a brief exit visit so they can collect safety information, but you are not obligated.
- Will travel or parking be reimbursed?
- Many trials reimburse for parking, mileage, and sometimes lodging if the site is far from your home. Reimbursement policies vary by sponsor and site. When you contact the trial team, ask specifically what is covered and how reimbursement is processed.
- Can my spouse or care partner come with me to visits?
- In most cases yes, and it is often encouraged. Care partners can help with notes, questions, and getting home safely after a long visit. Some study assessments do need to happen one on one, but care partners are usually welcome for the rest of the appointment.