Levodopa for Parkinson's (NCT06234995)
Improve stopping of impulsive movements
- Trial ID
- NCT06234995
- Official Title
- Cortical Electrophysiology of Response Inhibition in Parkinson's Disease
- Goal
- Improve stopping of impulsive movements
- Phase
- PHASE4
- Status
- RECRUITING
- Sponsor
- Emory University
- Study Type
- INTERVENTIONAL
- Enrollment
- 80 participants
- Conditions
- Parkinson Disease
- Interventions
- Levodopa, Clinical DBS Setting, Sham DBS, DBS Setting Maximizing Prefrontal Activation, DBS Setting Minimizing Prefrontal Activation
Summary For Families
They want to know whether the exact spot and how large the electrical field is in a small deep-brain area called the subthalamic nucleus change how well the brain’s front part can stop or control actions, since problems stopping movements and impulsive behaviors are common in Parkinson’s. To find out, researchers will record brain signals and test behavior before, during, and after placing deep brain stimulation leads, trying different stimulation settings (including a sham setting and settings to boost or lessen prefrontal engagement) and also looking at the effects of levodopa medication. The study is enrolling adults 45 to 75 years old with Parkinson’s who are at moderate stages or who are candidates for or already have deep brain stimulation, plus healthy adults in the same age range; some visits require the ability to pause medications or tolerate awake surgery.
Locations
- Emory University Hospital, Atlanta, Georgia, United States
- Emory Brain Health Center, Atlanta, Georgia, United States
Frequently Asked Questions
- What is this trial testing?
- This trial is studying Levodopa. They want to know whether the exact spot and how large the electrical field is in a small deep-brain area called the subthalamic nucleus change how well the brain’s front part can stop or control actions, since problems stopping movements and impulsive behaviors are common in Parkinson’s. To find out, researchers will record brain signals and test behavior before, during, and after placing deep brain stimulation leads, trying different stimulation settings (including a sham setting and settings to boost or lessen prefrontal engagement) and also looking at the effects of levodopa medication. The study is enrolling adults 45 to 75 years old with Parkinson’s who are at moderate stages or who are candidates for or already have deep brain stimulation, plus healthy adults in the same age range; some visits require the ability to pause medications or tolerate awake surgery.
- Who can participate?
- Participants must be between 45 Years and 75 Years.
- Where is this trial located?
- This trial is recruiting at 2 locations.
- 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 11 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 trial has a group that receives no study treatment (you would continue your usual care) alongside the treatment group. Because assignment is random, you have about a 1 in 2 chance (roughly 50%) of being in the no-treatment group, assuming the groups are filled equally. Ask the coordinator to confirm the exact assignment ratio.
- How many visits does this trial involve?
- Patients with PD participate for approximately 18 months and the study includes one preoperative visit, intraoperative data collection, and two post-operative visits; healthy controls participate for approximately one month and attend two study visits.
- What procedures are involved in this trial?
- Based on the protocol, this trial involves: Brain surgery / implanted device (invasive); Surgical procedure (invasive); Brain wave recording (EEG) (non-invasive); Wearable / at-home monitoring (non-invasive). Confirm the full schedule with the study coordinator.