NCT06234995 Cortical Electrophysiology of Response Inhibition in Parkinson's Disease
| NCT ID | NCT06234995 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Emory University |
| Condition | Parkinson Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 80 participants |
| Start Date | 2021-08-09 |
| Primary Completion | 2026-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 80 participants in total. It began in 2021-08-09 with a primary completion date of 2026-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Svjetlana Miocinovic, MD, PhD
PRINCIPAL INVESTIGATOR
Emory University
Frequently Asked Questions
Who can join the NCT06234995 clinical trial?
This trial is open to participants of all sexes, aged 45 Years or older, up to 75 Years, studying Parkinson Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06234995 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06234995 currently recruiting?
Yes, NCT06234995 is actively recruiting participants. Contact the research team at jonna.k.seppa@emory.edu for enrollment information.
Where is the NCT06234995 trial being conducted?
This trial is being conducted at Atlanta, United States, Atlanta, United States.
Who is sponsoring the NCT06234995 clinical trial?
NCT06234995 is sponsored by Emory University. The principal investigator is Svjetlana Miocinovic, MD, PhD at Emory University. The trial plans to enroll 80 participants.
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