Investigating cognitive changes in Parkinson's patients undergoing deep brain stimulation
Neurophysiology Biomarkers of Cognitive Impairment Associated With Deep Brain Stimulation
NA · Vanderbilt University Medical Center · NCT05933681
This study is testing how deep brain stimulation affects thinking and memory in people with Parkinson's disease to find ways to make the treatment safer for their brain health.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 160 (estimated) |
| Ages | 40 Years and up |
| Sex | All |
| Sponsor | Vanderbilt University Medical Center (other) |
| Locations | 1 site (Nashville, Tennessee) |
| Trial ID | NCT05933681 on ClinicalTrials.gov |
What this trial studies
This study focuses on understanding cognitive impairment in patients with Parkinson's Disease who are undergoing Deep Brain Stimulation (DBS). It aims to identify neurophysiology biomarkers associated with cognitive changes during and after DBS procedures. By analyzing neural recordings during surgery and post-implantation, the research seeks to optimize electrode placement and programming to reduce cognitive side effects related to DBS. The findings could lead to improved treatment strategies for managing cognitive health in Parkinson's patients.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older who are scheduled for deep brain stimulation surgery for Parkinson's Disease and can participate in intraoperative testing.
Not a fit: Patients who are under 18 years old or unable to participate in intraoperative testing will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the safety and efficacy of deep brain stimulation for Parkinson's patients by minimizing cognitive side effects.
How similar studies have performed: While there have been studies on deep brain stimulation and cognitive effects, this specific approach focusing on neurophysiology biomarkers is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: • Scheduled to undergo deep brain stimulation surgery under local anesthesia at Vanderbilt University Medical Center (Arm 1) * Active deep brain stimulation system with implantable pulse generator capable of recording local field potentials (Arm 2) * Diagnosis of Parkinson's disease as determined by a movement disorders specialist neurologist * Age at least 18 * Able to participate in intraoperative testing * English speaking Exclusion Criteria: * Age less than 18 * Not able to participate in intraoperative testing (ex unable to comprehend instructions or follow directions)
Where this trial is running
Nashville, Tennessee
- Vanderbilt University Medical Center — Nashville, Tennessee, United States (RECRUITING)
Study contacts
- Principal investigator: Sarah K Bick, MD — Vanderbilt University Medical Center
- Study coordinator: Isabel Long, BS
- Email: Isabel.Long@vumc.org
- Phone: 615-421-3046
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.
Conditions: Parkinson Disease, Deep Brain Stimulation, Cognitive impairment, Movement Disorders, Brain Diseases