observational-- no intervention for Parkinson's (NCT05656586)
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?
- 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 4 years and 2 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?
- This is an observational study, so there is no placebo and no experimental treatment is assigned. Researchers observe and collect information while you continue your usual care.
- How many visits does this trial involve?
- Recordings will be collected over a minimum of 4 weeks.