Neurophysiology Biomarkers of Cognitive Impairment Associated With Deep Brain Stimulation (NCT05933681) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Neurophysiology Biomarkers of Cognitive Impairment Associated With Deep Brain Stimulation
United States160 participantsStarted 2023-07-06
Plain-language summary
The study aims to investigate cognitive impairment associated with Deep Brain Stimulation (DBS) in Parkinson's Disease patients, with a focus on identifying neurophysiology biomarkers of DBS associated cognitive changes. Using neurophysiology data recorded during DBS surgeries and post-implantation, the research intends to identify biomarkers in order to optimize electrode placement, enhance programming, and ultimately minimize DBS-related cognitive side effects.
Who can participate
Age range
40 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Determination of DLPFC beta power a biomarker of DBS associated cognitive impairment in the acute stimulation setting
Timeframe: Baseline to end of Deep Brain Stimulation (DBS), approximately 3-4 hours
2
Determination of STN local field potential biomarkers of DBS mediated cognitive impairment following chronic stimulation