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
Plain-Language Summary
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.