Deep Brain Stimulation for Parkinson's (NCT05557864)
Map stimulation spots improving movement
- Trial ID
- NCT05557864
- Official Title
- Effects of Pallidal Deep Brain Stimulation Location on Motor Impairment in Parkinson's Disease; Udall Project 2 Aims 1 & 2
- Goal
- Map stimulation spots improving movement
- Phase
- NA
- Status
- RECRUITING
- Sponsor
- University of Minnesota
- Study Type
- INTERVENTIONAL
- Enrollment
- 24 participants
- Conditions
- Parkinson's Disease
- Interventions
- Deep Brain Stimulation
Summary For Families
They want to find out how the exact spot of deep brain stimulation changes movement in Parkinson's, noting both helpful and harmful effects so stimulation can be better tailored to each person. To do that, researchers will study people who already have deep brain stimulators placed in the globus pallidus or the subthalamic nucleus and use high-resolution brain images to map which stimulation locations improve or worsen motor signs; if stimulation of the upper part of the globus pallidus helps problems that do not respond to dopamine replacement therapy like levodopa, the results could change care. The trial is looking for people ages 21 to 89 with typical Parkinson's who have those implants and existing high-resolution brain scans; people with major other neurological or musculoskeletal problems, dementia or cognitive impairment on brief cognitive testing, or post-surgery complications are not eligible.
Locations
- University Of Minnesota, Minneapolis, Minnesota, United States
Frequently Asked Questions
- What is this trial testing?
- This trial is studying Deep Brain Stimulation. They want to find out how the exact spot of deep brain stimulation changes movement in Parkinson's, noting both helpful and harmful effects so stimulation can be better tailored to each person. To do that, researchers will study people who already have deep brain stimulators placed in the globus pallidus or the subthalamic nucleus and use high-resolution brain images to map which stimulation locations improve or worsen motor signs; if stimulation of the upper part of the globus pallidus helps problems that do not respond to dopamine replacement therapy like levodopa, the results could change care. The trial is looking for people ages 21 to 89 with typical Parkinson's who have those implants and existing high-resolution brain scans; people with major other neurological or musculoskeletal problems, dementia or cognitive impairment on brief cognitive testing, or post-surgery complications are not eligible.
- Who can participate?
- Participants must be between 21 Years and 89 Years.
- Where is this trial located?
- This trial is recruiting at 1 location.
- Does it cost anything to join?
- You are never charged a fee to join a legitimate clinical trial, and the study treatment and study-specific tests are provided by the trial sponsor at no charge. In the US, routine care you would receive anyway can still be billed to you or your insurance; coverage rules differ by country, and trials in the UK and Canada usually run through public health systems. Travel, parking, and time are real costs, and some trials reimburse them while others do not. Before enrolling, ask the study coordinator to explain in writing what is and is not covered.
- How long does the trial last?
- This trial is estimated to last approximately 10 years and 4 months.
- 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.
- 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.
- Will I get a placebo in this trial?
- Everyone in this trial receives the experimental treatment. There is no placebo group.
- What procedures are involved in this trial?
- Based on the protocol, this trial involves: Brain surgery / implanted device (invasive). Confirm the full schedule with the study coordinator.