Improve ability to stop actions
- Trial ID
- NCT06234995
- Official Title
- Cortical Electrophysiology of Response Inhibition in Parkinson's Disease
- Goal
- Improve ability to stop actions
- 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
The team wants to understand how prefrontal brain circuits control the ability to stop or inhibit actions in Parkinson's, and how medication and DBS change those signals. Participants have cortical electrophysiology recorded while on and off levodopa, and while deep brain stimulation is set to their clinical setting, turned off, or tuned to maximize or minimize prefrontal activation; levodopa replaces dopamine and can alter motor and cognitive control, DBS delivers timed electrical pulses to deep brain targets and can be adjusted to increase or decrease signals reaching the prefrontal cortex, and a sham DBS setting provides a control. They are recruiting people with idiopathic PD across three groups: mid-stage PD (Hoehn and Yahr 2 to 4) for non-surgical recordings, candidates for awake DBS surgery with a normal MRI, and people with a functioning DBS system, plus healthy controls age 45 to 75. Key exclusions include dementia, severe tremor or dyskinesia that would corrupt recordings, inability to safely hold medications or tolerate DBS changes, and major medical risks.
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. The team wants to understand how prefrontal brain circuits control the ability to stop or inhibit actions in Parkinson's, and how medication and DBS change those signals. Participants have cortical electrophysiology recorded while on and off levodopa, and while deep brain stimulation is set to their clinical setting, turned off, or tuned to maximize or minimize prefrontal activation; levodopa replaces dopamine and can alter motor and cognitive control, DBS delivers timed electrical pulses to deep brain targets and can be adjusted to increase or decrease signals reaching the prefrontal cortex, and a sham DBS setting provides a control. They are recruiting people with idiopathic PD across three groups: mid-stage PD (Hoehn and Yahr 2 to 4) for non-surgical recordings, candidates for awake DBS surgery with a normal MRI, and people with a functioning DBS system, plus healthy controls age 45 to 75. Key exclusions include dementia, severe tremor or dyskinesia that would corrupt recordings, inability to safely hold medications or tolerate DBS changes, and major medical risks.
- 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?
- 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 11 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.