Reduce tremor through brain stimulation
- Trial ID
- NCT06013956
- Official Title
- Identifying Circuit Dynamics Underlying Motor Dysfunction in Parkinson's Disease Using Real-Time Neural Control
- Goal
- Reduce tremor through brain stimulation
- Phase
- PHASE4
- Status
- RECRUITING
- Sponsor
- David Escobar
- Study Type
- INTERVENTIONAL
- Enrollment
- 25 participants
- Conditions
- Parkinson Disease
- Interventions
- Neurostimulation, Carbidopa 25/Levodopa 100Mg Tab
Summary For Families
The goal is to pinpoint the specific brain circuit activity that causes tremor, slowness, and other motor problems in Parkinson's so stimulation can be timed and tuned to reduce those symptoms. The approach uses deep brain stimulation targeted to the subthalamic nucleus with real-time neural control, meaning the device watches brain signals and adjusts electrical stimulation on the fly, and researchers will test how that responsive stimulation works alongside carbidopa/levodopa, the standard medication that boosts brain dopamine to improve movement. Looking for adults 18 to 80 with idiopathic Parkinson's who have been cleared as candidates for STN-DBS, can give informed consent, and can tolerate brief delays in taking their Parkinson's meds; people with secondary parkinsonism, stroke, other progressive CNS diseases, or conditions that would interfere with safety or compliance are excluded.
Locations
- Cleveland Clinic, Cleveland, Ohio, United States
Frequently Asked Questions
- What is this trial testing?
- This trial is studying Neurostimulation. The goal is to pinpoint the specific brain circuit activity that causes tremor, slowness, and other motor problems in Parkinson's so stimulation can be timed and tuned to reduce those symptoms. The approach uses deep brain stimulation targeted to the subthalamic nucleus with real-time neural control, meaning the device watches brain signals and adjusts electrical stimulation on the fly, and researchers will test how that responsive stimulation works alongside carbidopa/levodopa, the standard medication that boosts brain dopamine to improve movement. Looking for adults 18 to 80 with idiopathic Parkinson's who have been cleared as candidates for STN-DBS, can give informed consent, and can tolerate brief delays in taking their Parkinson's meds; people with secondary parkinsonism, stroke, other progressive CNS diseases, or conditions that would interfere with safety or compliance are excluded.
- 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 Phase 4 trial is estimated to last approximately 4 years and 10 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.