NCT06234995 · Emory University
Cortical Electrophysiology of Response Inhibition in Parkinson's Disease
What this study is about
Patients with Parkinson's Disease will be studied before, during, and after a deep brain stimulation implantation procedure to see if the stimulation location and the size of the electrical field produced by subthalamic nucleus (STN) DBS determine the degree to which DBS engages circuits that involve prefrontal cortex executive functions, and therefore have a direct impact on the patient's ability to inhibit actions.
View original scientific description
Patients with Parkinson's Disease will be studied before, during, and after a deep brain stimulation implantation procedure to see if the stimulation location and the size of the electrical field produced by subthalamic nucleus (STN) DBS determine the degree to which DBS engages circuits that involve prefrontal cortex executive functions, and therefore have a direct impact on the patient's ability to inhibit actions.
Interventions
DRUG
Levodopa
Participants will take levodopa in dosages prescribed by their care provider. Patients will be instructed to not take their regularly prescribed PD medications for 12 hours prior to the study assessment, as is typical for clinical evaluations in patients with PD. Participants will be tested in both levodopa-off (after 12 hours of not having medication) and levodopa-on states.
DEVICE
Clinical DBS Setting
Deep brain stimulation performed with the patients' optimized clinical setting.
DEVICE
Sham DBS
Deep brain stimulation performed with sham stimulation.
DEVICE
DBS Setting Maximizing Prefrontal Activation
Deep brain stimulation performed to maximize the activation of the prefrontal cortico-STN projections.
DEVICE
DBS Setting Minimizing Prefrontal Activation
Deep brain stimulation performed to minimize the activation of the prefrontal cortico-STN projections.
Primary outcome measures
Response Time During Go/No-Go (GNG) Task for Participants in Aim 1
Time frame: Day 1 (before and after levodopa dosage for persons with PD)
The GNG task is a tool for measuring impulsiveness by asking participants to respond to a cue signal for pressing a button. There are Go trials, where the button should be pressed, and No-Go trials, where the button should not be pressed. A total of 240 trials will be administered (5 blocks of 30) after an initial practice block (12 trials). An additional 120 Go only trials will be administered prior to the Go/No-Go blocks and serve as a control without inhibitory demands. Participants with PD attend a single study visit, completing this task twice: once after not taking PD medications for 12 hours and again after levodopa dosage. Healthy controls complete the task twice during one study visit. Response time is measured in milliseconds (ms) during the GNG task.
Percent of Errors During Go/No-Go (GNG) Task for Participants in Aim 1
Time frame: Day 1 (before and after levodopa dosage for persons with PD)
The GNG task is a tool for measuring impulsiveness by asking participants to respond to a cue signal for pressing a button. There are Go trials, where the button should be pressed, and No-Go trials, where the button should not be pressed. A total of 240 trials will be administered (5 blocks of 30) after an initial practice block (12 trials). An additional 120 Go only trials will be administered prior to the Go/No-Go blocks and serve as a control without inhibitory demands. Participants with PD attend a single study visit, completing this task twice: once after not taking PD medications for 12 hours and again after levodopa dosage. Healthy controls complete the task twice during one study visit. Accuracy is measured as the percentage of errors during the GNG task.
Stopping Time During Modified Stop Signal (MSS) Task for Participants in Aim 1
Time frame: Day 1 (before and after levodopa dosage for persons with PD)
For the MSS task, a fixation cross indicates the start of a trial. After a variable delay (300-700 ms) this signal is replaced by a green Go signal circle, prompting the subject to start to make circling movements with a computer mouse at approximately one rotation per second using dominant hand. After 500 ms the green circle is replaced by a visual countdown to when a red Stop signal appears (planned stop). In 50% of the trials, the Stop signal appears unexpectedly during the countdown (unplanned stop). A total of 120 trials will be administered (10 blocks of 12). Participants with PD attend a single study visit, completing this task twice: once after not taking PD medications for 12 hours and again after levodopa dosage. Healthy controls complete the task twice during one study visit. Stopping time is measured in milliseconds.
Response Time During Go/No-Go (GNG) Task for Participants in Aim 3
Time frame: Up to 12 months post-implantation of DBS leads
The GNG task is a tool for measuring impulsiveness by asking participants to respond to a cue signal for pressing a button. There are Go trials, where the button should be pressed, and No-Go trials, where the button should not be pressed. A total of 240 trials will be administered (5 blocks of 30) after an initial practice block (12 trials). An additional 120 Go only trials will be administered prior to the Go/No-Go blocks and serve as a control without inhibitory demands. Participants with PD attend two study visits, within a 4-week period, at 6 to 12 months after implantation of the DBS leads. Participants will not take PD medications for 12 hours prior to the study visit. During each study visit chronic DBS will be turned off and two stimulation settings will be tested at each study visit so that participants all four stimulation settings over the two study visits. Response time is measured in milliseconds (ms) during the GNG task.
Percent of Errors During Go/No-Go (GNG) Task for Participants in Aim 3
Time frame: Up to 12 months post-implantation of DBS leads
The GNG task is a tool for measuring impulsiveness by asking participants to respond to a cue signal for pressing a button. There are Go trials, where the button should be pressed, and No-Go trials, where the button should not be pressed. A total of 240 trials will be administered (5 blocks of 30) after an initial practice block (12 trials). An additional 120 Go only trials will be administered prior to the Go/No-Go blocks and serve as a control without inhibitory demands. Participants with PD attend two study visits, within a 4-week period, at 6 to 12 months after implantation of the DBS leads. Participants will not take PD medications for 12 hours prior to the study visit. During each study visit chronic DBS will be turned off and two stimulation settings will be tested at each study visit so that participants all four stimulation settings over the two study visits. Accuracy is measured as the percentage of errors during the GNG task.
Stopping Time During Modified Stop Signal (MSS) Task for Participants in Aim 3
Time frame: Up to 12 months post-implantation of DBS leads
For the MSS task, a fixation cross indicates the start of a trial. After a variable delay (300-700 ms) this signal is replaced by a green Go signal circle, prompting the subject to start to make circling movements with a computer mouse at approximately one rotation per second using dominant hand. After 500 ms the green circle is replaced by a visual countdown to when a red Stop signal appears (planned stop). In 50% of the trials, the Stop signal appears unexpectedly during the countdown (unplanned stop). A total of 120 trials will be administered. Participants with PD attend two study visits, within a 4-week period, at 6 to 12 months after implantation of the DBS leads. Participants will not take PD medications for 12 hours prior to the study visit. During each visit chronic DBS will be turned off and two stimulation settings will be tested so that participants all four stimulation settings over the two study visits. Stopping time is measured in milliseconds.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- for Persons with Parkinson's Disease for Aim 1:
- diagnosis of idiopathic Parkinson's disease (PD)
- Hoehn and Yahr (H\&Y) stage 2-4 (off medication)
Exclusion criteria
- for Persons with Parkinson's Disease for Aim 1:
- severe tremor at rest or severe dyskinesia which would cause significant artifacts in electrophysiological signals
- inability to hold antiparkinsonian medications for research recordings
- non-English speaker Inclusion Criteria for Persons with Parkinson's Disease for Aim 2:
- diagnosis of idiopathic PD
- there is a clinical indication for DBS surgery
- normal preoperative MRI
- ability to tolerate microelectrode-guided neurosurgery in an awake state Exclusion Criteria for Persons with Parkinson's Disease for Aim 2:
- presence of a coagulopathy
- uncontrolled hypertension
- heart disease
- other medical conditions considered to increase the patient's risk for surgical complications Inclusion Criteria for Persons with Parkinson's Dis
Where
- Atlanta, Georgia
Collaborators
National Institute of Neurological Disorders and Stroke (NINDS)
Related conditions & keywords
Frequently asked questions
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Data: ClinicalTrials.gov · synced Mar 27, 2026 · Source of record for eligibility and locations