Cortical Electrophysiology of Response Inhibition in Parkinson's Disease
This study is looking at how Deep Brain Stimulation (DBS) affects the ability to stop or inhibit actions in people with Parkinson's Disease (PD). Researchers will test different DBS settings, including your usual clinical setting, a sham (inactive) setting, and settings designed to either maximize or minimize activity in a specific brain area (prefrontal cortico-STN projections). They will also test the effects of levodopa, a common PD medication. You may be able to join if you are 45-75 years old, have been diagnosed with idiopathic Parkinson's disease, and are in Hoehn and Yahr (H&Y) stage 2-4 (when off medication). Success in this study will be measured by how quickly and accurately participants perform tasks that require them to stop an action. The current recruitment status is unclear.
- Study design
- This is an interventional study planning to enroll 80 participants. The study is not blinded or randomized, and the phase is not specified.
- What's involved
- Participants will be asked to not take their regular PD medications for 12 hours before study assessments. You will perform tasks that measure your ability to stop actions before and after taking levodopa.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be assessed on Day 1, before and after levodopa dosage.
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Cortical Electrophysiology of Response Inhibition in Parkinson's Disease
At a glance
Conditions
NCT06234995
Where you'd take part
This study runs at 2 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Emory Brain Health Center
Atlanta, Georgiano site contact published
Recruiting
Emory University Hospital
Atlanta, Georgiano site contact published
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- Svjetlana Miocinovic, MD, PhD · PRINCIPAL_INVESTIGATOR · Emory University
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
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Inclusion
Exclusion
What this trial measures
- Response Time During Go/No-Go (GNG) Task for Participants in Aim 1Day 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 1Day 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 1Day 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 3Up 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 3Up 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 3Up 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.