Understanding how deep brain stimulation affects decision-making in Parkinson's Disease
Cortical Electrophysiology of Response Inhibition in Parkinson's Disease
This study tests how deep brain stimulation affects decision-making and impulse control in people with Parkinson's Disease.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 45 Years to 75 Years |
| Sex | All |
| Sponsor | Emory University Academic / other |
| Locations | 2 sites (Atlanta, Georgia and 1 other locations) |
| Trial ID | NCT06234995 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of deep brain stimulation (DBS) on executive functions in patients with Parkinson's Disease (PD). It examines how the location of stimulation and the size of the electrical field produced by DBS influence the brain circuits involved in response inhibition. Patients will be assessed before, during, and after the DBS implantation procedure to determine the impact on their ability to control impulsive actions. The research aims to shed light on the relationship between DBS and cognitive functions critical for daily decision-making.
Who should consider this trial
Good fit: Ideal candidates include individuals diagnosed with idiopathic Parkinson's Disease who are in Hoehn and Yahr stages 2-4 and are eligible for DBS surgery.
Not a fit: Patients with severe tremor, dyskinesia, dementia, or other significant medical conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved DBS techniques that enhance cognitive control and reduce impulsivity in patients with Parkinson's Disease.
How similar studies have performed: Other studies have explored the effects of DBS on motor functions, but this specific focus on executive function and response inhibition is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Atlanta, Georgia and 1 other locations
- Emory University Hospital — Atlanta, Georgia, United States (Recruiting)
- Emory Brain Health Center — Atlanta, Georgia, United States (Recruiting)
Study contacts
- Principal investigator: Svjetlana Miocinovic, MD, PhD — Emory University
- Study coordinator: Jonna Seppa
- Email: jonna.k.seppa@emory.edu
- Phone: 404-727-1509
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.