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| Name | Class |
|---|---|
| United States Department of Defense | FED |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Determination of DLPFC neurophysiology biomarkers of DBS associated cognitive impairment | Experimental | Neurophysiology recordings will be performed from dorsolateral prefrontal cortex (DLPFC) during deep brain stimulation surgery, with and without STN or GPI stimulation, at rest and during a working memory task. |
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| Neurophysiology biomarkers of DBS mediated cognitive impairment following chronic stimulation | Experimental | Neurophysiology recordings will be performed from subthalamic nucleus (STN) or globus pallidus internus (GPI) with stimulation on and off, at rest and during a working memory task, in patients who have previously been implanted with DBS and have implantable pulse generators capable of recording local field potentials. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Neural recordings and stimulation | Device | Neural activities from the dorsolateral prefrontal cortex and implanted DBS generator will be recorded, during resting and working memory tasks, and with the DBS target turned on and off. |
| Measure | Description | Time Frame |
|---|---|---|
| Determination of DLPFC beta power a biomarker of DBS associated cognitive impairment in the acute stimulation setting | Working memory tasked will be conducted during surgery, and local field potentials (LFPs) will be recorded from the DLPFC both at rest and during task execution, under two conditions: with and without stimulation. | Baseline to end of Deep Brain Stimulation (DBS), approximately 3-4 hours |
| Determination of STN local field potential biomarkers of DBS mediated cognitive impairment following chronic stimulation | Local field potentials will be recorded from subthalamic nucleus or globus pallidus internus in patients with an existing DBS system with implantable pulse generator capable of recording local field potentials. Recordings will be performed at rest and during a working memory task, with DBS on and off. | 1 hour |
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Inclusion Criteria:
• Scheduled to undergo deep brain stimulation surgery under local anesthesia at Vanderbilt University Medical Center (Arm 1)
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sarah K Bick, MD | Vanderbilt University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | United States |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| D060825 | Cognitive Dysfunction |
| D009069 | Movement Disorders |
| D001927 | Brain Diseases |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |