Optimize brain stimulation improving walking
- Trial ID
- NCT05934747
- Official Title
- Aim 3 Particle Swarm Optimization Postural Instability Gait Disorder
- Goal
- Optimize brain stimulation improving walking
- Phase
- NA
- Status
- RECRUITING
- Sponsor
- University of Minnesota
- Study Type
- INTERVENTIONAL
- Enrollment
- 30 participants
- Conditions
- Parkinson's Disease and Parkinsonism
- Interventions
- DBS
Summary For Families
The goal is to reduce postural instability and walking problems in Parkinson's, focusing on balance and gait issues that often do not fully respond to medication. The approach uses your existing deep brain stimulation, DBS, leads in the subthalamic nucleus or globus pallidus and a particle swarm optimization computer method that quickly tests and recommends stimulation settings that better modulate the brain circuits controlling gait and posture. Because the trial tweaks electrical stimulation rather than changing drugs, it can be used alongside levodopa; DBS delivers pulses that alter abnormal brain activity to improve movement, and the algorithm aims to find the pulse patterns most helpful for walking and balance. They are enrolling people 18 to 85 with Parkinson's who already have bilateral STN or GP DBS implanted at least three months, can walk off medication and off stimulation for testing, and meet cognitive screening; candidates must also have preoperative 7T MRI and postoperative CT, and people with other causes of gait impairment, broken DBS contacts, near-depleted IPG batteries, or pregnancy/nursing are excluded.
Locations
- University of Minnesota, Minneapolis, Minnesota, United States
Frequently Asked Questions
- What is this trial testing?
- This trial is studying DBS. The goal is to reduce postural instability and walking problems in Parkinson's, focusing on balance and gait issues that often do not fully respond to medication. The approach uses your existing deep brain stimulation, DBS, leads in the subthalamic nucleus or globus pallidus and a particle swarm optimization computer method that quickly tests and recommends stimulation settings that better modulate the brain circuits controlling gait and posture. Because the trial tweaks electrical stimulation rather than changing drugs, it can be used alongside levodopa; DBS delivers pulses that alter abnormal brain activity to improve movement, and the algorithm aims to find the pulse patterns most helpful for walking and balance. They are enrolling people 18 to 85 with Parkinson's who already have bilateral STN or GP DBS implanted at least three months, can walk off medication and off stimulation for testing, and meet cognitive screening; candidates must also have preoperative 7T MRI and postoperative CT, and people with other causes of gait impairment, broken DBS contacts, near-depleted IPG batteries, or pregnancy/nursing are excluded.
- Who can participate?
- Participants must be between 18 Years and 85 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 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.