Brain stimulation reduces persistent stiffness
- Trial ID
- NCT05656586
- Official Title
- Mechanisms and Effects of Pallidal Deep Brain Stimulation on Levodopa Resistant Motor Signs in Parkinson's Disease; Udall Project 2 Aim 2A&C
- Goal
- Brain stimulation reduces persistent stiffness
- Status
- RECRUITING
- Sponsor
- University of Minnesota
- Study Type
- OBSERVATIONAL
- Enrollment
- 36 participants
- Conditions
- Parkinson Disease
- Interventions
- observational-- no intervention
Summary For Families
The goal is to understand how stimulation of the globus pallidus internus helps movement problems in Parkinson's that do not respond well to levodopa, like persistent rigidity or dystonia. The team will observe people already implanted with the Medtronic Percept DBS system, recording brain signals and motor performance during lab tasks and, when the device is set to sense, during at-home monitoring to link GPi activity patterns with changes in movement. Pallidal DBS delivers controlled electrical pulses to the GPi to normalize abnormal firing patterns, which can reduce involuntary movements or stiffness, and it is used alongside levodopa rather than replacing it. Participants must have GPi DBS with a Percept device activated at least three months, be able to consent and perform the motor tasks, and are excluded for dementia, major musculoskeletal or other neurologic disorders, post-op complications that affect safety, or incompatible DBS settings for the at-home portion.
Locations
- University of Minnesota, Minneapolis, Minnesota, United States
Frequently Asked Questions
- What is this trial testing?
- This trial is studying observational-- no intervention. The goal is to understand how stimulation of the globus pallidus internus helps movement problems in Parkinson's that do not respond well to levodopa, like persistent rigidity or dystonia. The team will observe people already implanted with the Medtronic Percept DBS system, recording brain signals and motor performance during lab tasks and, when the device is set to sense, during at-home monitoring to link GPi activity patterns with changes in movement. Pallidal DBS delivers controlled electrical pulses to the GPi to normalize abnormal firing patterns, which can reduce involuntary movements or stiffness, and it is used alongside levodopa rather than replacing it. Participants must have GPi DBS with a Percept device activated at least three months, be able to consent and perform the motor tasks, and are excluded for dementia, major musculoskeletal or other neurologic disorders, post-op complications that affect safety, or incompatible DBS settings for the at-home portion.
- Who can participate?
- Eligibility criteria vary. Check the full listing on ClinicalTrials.gov for detailed inclusion and exclusion criteria.
- 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 4 years and 2 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.