Recruiting

Observational Study

Sponsor:

Emory University

Code:

NCT06234995

Conditions

Parkinson Disease

Eligibility Criteria

Sex: All

Age: 45 - 70+

Healthy Volunteers: Accepted

Interventions

Levodopa

Clinical DBS Setting

Sham DBS

DBS Setting Maximizing Prefrontal Activation

DBS Setting Minimizing Prefrontal Activation

Study Details

Brief summary:

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.

Conditions

Parkinson Disease

Study ID

NCT06234995

Start date

Aug 9, 2021

Status verified date

Aug, 2026

Completion date

Sep, 2027

Anticipated

Primary completion date

Sep, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 45 - 70+

Healthy Volunteers: Accepted

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
  • dementia
  • 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 Disease for Aim 3:

  • diagnosis of idiopathic PD
  • functioning DBS system

Exclusion Criteria for Persons with Parkinson's Disease for Aim 3:

  • severe tremor at rest or severe dyskinesia which would cause significant artifacts in electrophysiological signals
  • inability to hold antiparkinsonian medications for research recordings
  • inability to tolerate temporary discontinuation of DBS therapy or alteration of stimulation settings for research purposes
  • other medical conditions considered to increase the patient's risk for surgical complications

Inclusion Criteria for Healthy Controls:

  • age 45-75

Exclusion Criteria for Healthy Controls:

  • history of a neuropsychiatric disorder and/or treatment with psychotropic medications
  • non-English speaker

Study Design

Enrollment

80 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Patients with Parkinson's Disease (PD)

Patients with PD complete motor response inhibitions tasks under multiple conditions, depending on the study aim they are participating in. Those who are participants in Aim 1 of the study are able to also participate in Aims 2 and 3 if they are having a clinically indicated DBS leads implanted. Patients with PD participate in the study for approximately 18 months which includes one preoperative visit, intraoperative data collection and two post-operative visits. As part of the motor inhibition tasks, EEG signals are recorded. A cap similar to a swim cap is placed on the head of the subject, and gel is applied to the hair to get a good signal. Electrodes are attached to the cap for recording of brain signals. A few additional flat electrodes are placed on the skin to record hand muscle activity (for GNG task) and near the eyes to record eye movements. Accelerometer sensors are utilized to record arm movements (for MSS task).

no intervention: Healthy Controls

Healthy participants complete motor response inhibition tasks during two study visits. Healthy controls participate for approximately one month, which includes two study visits. As part of the motor inhibition tasks, EEG signals are recorded. A cap similar to a swim cap is placed on the head of the subject, and gel is applied to the hair to get a good signal. Electrodes are attached to the cap for recording of brain signals. A few additional flat electrodes are placed on the skin to record hand muscle activity (for GNG task) and near the eyes to record eye movements. Accelerometer sensors are utilized to record arm movements (for MSS task).

Interventions

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.

Clinical DBS Setting

Deep brain stimulation performed with the patients' optimized clinical setting.

Sham DBS

Deep brain stimulation performed with sham stimulation.

DBS Setting Maximizing Prefrontal Activation

Deep brain stimulation performed to maximize the activation of the prefrontal cortico-STN projections.

DBS Setting Minimizing Prefrontal Activation

Deep brain stimulation performed to minimize the activation of the prefrontal cortico-STN projections.

Primary outcome measure

  • 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) ]
  • 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) ]
  • 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) ]
  • Response Time During Go/No-Go (GNG) Task for Participants in Aim 3 [ Time Frame: Up to 12 months post-implantation of DBS leads ]
  • 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 ]
  • Stopping Time During Modified Stop Signal (MSS) Task for Participants in Aim 3 [ Time Frame: Up to 12 months post-implantation of DBS leads ]

Central Contacts and Locations

Central contacts

Jonna Seppa

404-727-1509jonna.k.seppa@emory.edu

Svjetlana Miocinovic, MD, PhD

404-712-9065

Locations

Emory University Hospital

Recruiting

Atlanta, Georgia, United States, 30322

Emory Brain Health Center

Recruiting

Atlanta, Georgia, United States, 30329

More Information

Sponsor

Emory University

Last update posted

Sep 3, 2026

Last verified

Aug, 2026

Keywords

  • Parkinson's Disease
  • Deep brain stimulation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Emory University on 2026-09-03.