Neurostimulation for Parkinson's (NCT06013956)
Brain stimulation improves movement speed
- Trial ID
- NCT06013956
- Official Title
- Identifying Circuit Dynamics Underlying Motor Dysfunction in Parkinson's Disease Using Real-Time Neural Control
- Goal
- Brain stimulation improves movement speed
- 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 find out whether changing specific brain rhythms in the movement circuit affects the slowed movement and stiffness many people with Parkinson's have, and to use that knowledge to guide future personalized, feedback-controlled deep brain stimulation. The team will connect the implanted deep brain stimulation leads to a system that records brain activity and can, in real time, suppress or boost "beta" brain rhythms (about 11 to 35 cycles per second) using a technique called evoked interference closed-loop deep brain stimulation, while also testing effects on and off levodopa and using very detailed magnetic resonance imaging and computer models to map the pathways involved. Adults aged 18 to 80 who have typical Parkinson's disease and are already judged to need deep brain stimulation surgery targeting the subthalamic nucleus, who can give consent and tolerate delays in taking their usual Parkinson's medicines, can join. People with secondary Parkinsonism, recent stroke, other progressive brain diseases, or other conditions that would make participation unsafe or unreliable are not eligible; about 25 people will be enrolled.
Locations
- Cleveland Clinic, Cleveland, Ohio, United States
Frequently Asked Questions
- What is this trial testing?
- This trial is studying Neurostimulation. The goal is to find out whether changing specific brain rhythms in the movement circuit affects the slowed movement and stiffness many people with Parkinson's have, and to use that knowledge to guide future personalized, feedback-controlled deep brain stimulation. The team will connect the implanted deep brain stimulation leads to a system that records brain activity and can, in real time, suppress or boost "beta" brain rhythms (about 11 to 35 cycles per second) using a technique called evoked interference closed-loop deep brain stimulation, while also testing effects on and off levodopa and using very detailed magnetic resonance imaging and computer models to map the pathways involved. Adults aged 18 to 80 who have typical Parkinson's disease and are already judged to need deep brain stimulation surgery targeting the subthalamic nucleus, who can give consent and tolerate delays in taking their usual Parkinson's medicines, can join. People with secondary Parkinsonism, recent stroke, other progressive brain diseases, or other conditions that would make participation unsafe or unreliable are not eligible; about 25 people will be enrolled.
- 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?
- 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 Phase 4 trial is estimated to last approximately 4 years and 10 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 a crossover trial: instead of staying in one group, you move through a sequence of assignments, so you receive the active treatment during at least one period of the study. Ask the coordinator for the exact sequence and how long each phase lasts.
- What procedures are involved in this trial?
- Based on the protocol, this trial involves: Brain surgery / implanted device (invasive); Surgical procedure (invasive); MRI scan (non-invasive). Confirm the full schedule with the study coordinator.