Reduce tremor stiffness and slowness
- 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
- Reduce tremor stiffness and slowness
- 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
The team wants to know whether the exact location of deep brain stimulation in the globus pallidus versus the subthalamic nucleus changes how much motor symptoms like tremor, stiffness, and slowness improve. They use the already implanted DBS devices to deliver continuous electrical pulses that modulate overactive brain circuits, they map electrode positions on high-resolution 7T MRI and relate location to motor benefit, and DBS can often reduce symptoms and sometimes allow lower levodopa doses or change medication response. Adults 21 to 89 with idiopathic Parkinson's who already have GP or STN DBS and existing 7T imaging are eligible, while people with major musculoskeletal or other neurologic disorders, dementia, or post-operative complications are excluded.
Locations
- University Of Minnesota, Minneapolis, Minnesota, United States
Frequently Asked Questions
- What is this trial testing?
- This trial is studying Deep Brain Stimulation. The team wants to know whether the exact location of deep brain stimulation in the globus pallidus versus the subthalamic nucleus changes how much motor symptoms like tremor, stiffness, and slowness improve. They use the already implanted DBS devices to deliver continuous electrical pulses that modulate overactive brain circuits, they map electrode positions on high-resolution 7T MRI and relate location to motor benefit, and DBS can often reduce symptoms and sometimes allow lower levodopa doses or change medication response. Adults 21 to 89 with idiopathic Parkinson's who already have GP or STN DBS and existing 7T imaging are eligible, while people with major musculoskeletal or other neurologic disorders, dementia, or post-operative complications are excluded.
- 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?
- 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 10 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.