Reduce freezing episodes during walking
- Trial ID
- NCT06911229
- Official Title
- Neurophysiology of Locomotor Adaptation and Freezing of Gait in Parkinson's Disease
- Goal
- Reduce freezing episodes during walking
- Phase
- NA
- Status
- RECRUITING
- Sponsor
- University of Florida
- Study Type
- INTERVENTIONAL
- Enrollment
- 60 participants
- Conditions
- Parkinson Disease
- Interventions
- Deep Brain Stimulation (DBS)
Summary For Families
The goal is to pinpoint how the brain circuits that control walking break down in Parkinson's, especially during freezing of gait and when people have to adapt their steps. The team will study people who already have chronically implanted, optimized deep brain stimulation, recording brain signals while participants walk so researchers can see how the electrical stimulation, which sends continuous pulses to motor circuits to normalize abnormal signals and improve movement, relates to freezing and gait adaptation. They are enrolling adults 18 to 80 with a confirmed idiopathic Parkinson's diagnosis who have had stable DBS for at least six months, are ambulatory without walking aids, and do not have dementia or other neurologic conditions like atypical parkinsonism.
Locations
- University of Florida, Gainesville, Florida, United States
Frequently Asked Questions
- What is this trial testing?
- This trial is studying Deep Brain Stimulation (DBS). The goal is to pinpoint how the brain circuits that control walking break down in Parkinson's, especially during freezing of gait and when people have to adapt their steps. The team will study people who already have chronically implanted, optimized deep brain stimulation, recording brain signals while participants walk so researchers can see how the electrical stimulation, which sends continuous pulses to motor circuits to normalize abnormal signals and improve movement, relates to freezing and gait adaptation. They are enrolling adults 18 to 80 with a confirmed idiopathic Parkinson's diagnosis who have had stable DBS for at least six months, are ambulatory without walking aids, and do not have dementia or other neurologic conditions like atypical parkinsonism.
- Who can participate?
- Participants must be between 18 Years and 80 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 3 years and 5 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.