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| ID | Type | Description | Link |
|---|---|---|---|
| 1K99NS131447-01 | U.S. NIH Grant/Contract | View source | |
| 4R00NS131447-03 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Neurological Disorders and Stroke (NINDS) | NIH |
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The objective of this research study is to understand how Deep Brain Stimulation (DBS) targeting the subthalamic nucleus (STN) affects cognitive networks in the brain, potentially leading to cognitive decline in patients with Parkinson's Disease (PD). A total of 55 participants with PD who have undergone DBS surgery will be recruited from MUSC's Clinical DBS Program. Participants will attend two post-DBS visits: a 3-hour visit for consent, demographic, and cognitive assessments, and a 3-hour DBS-MRI visit to evaluate brain network connectivity with stimulation ON and OFF. These findings will help improve patient selection for surgery and optimize the selection of stimulation targets that minimize undesirable cognitive side effects.
Deep brain stimulation (DBS) targeting the subthalamic nucleus (STN) is a well-established surgical intervention to treat Parkinson's Disease (PD) patients with disabling motor fluctuations and dyskinesias. Although this therapy is effective for motor complications, a subset of patients will go on to experience cognitive decline, which can overshadow improvements in the quality of life provided by STN-DBS. This accelerated decline in cognition occurs in patients despite rigorous evaluation of their neuropsychological status prior to surgery. While the factors contributing to cognitive decline following DBS remain unclear, there is evidence this may be the result of 1) limited cognitive reserve prior to DBS surgery, 2) stimulation that interferes with cognitive networks, and/or 3) a microlesion effect due to placement of the lead. This research seeks to identify how DBS-induced changes in neural connectivity contribute to cognitive decline and how brain microstructure influences these changes. Understanding how these factors has the potential to improve patient selection for surgery and optimize the selection of stimulation targets that minimize undesirable cognitive side effects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with Parkinson's Disease undergoing DBS |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DBS combined with fMRI | Other | Participants will undergo fMRI scanning while their DBS device is either turned OFF or ON. BOLD (blood oxygen level dependent) changes in response to DBS will be evaluated across PD participants. These scans and DBS procedure will be used for research purposes only and are not for treatment or diagnostic purposes. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in executive function performance | Cognitive domains known to be affected by subthalamic deep brain stimulation (STN-DBS) will be evaluated using a standardized neuropsycholoical battery. A composite measure of tests within the executive function domain (task-switching, verbal fluency, and inhibitory control) will be assessed as the primary outcome measure for behavior. | Baseline and approximately 1 year (10-14 months) following deep brain stimulation |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Language and Attention | Cognitive domains known to be affected by subthalamic deep brain stimulation (STN-DBS) will be evaluated using a standardized neuropsycholoical battery. A composite measure of tests within the language and attention domains will be assessed as secondary outcome measure for behavior. | Baseline and approximately 1 year (10-14 months) following deep brain stimulation |
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Inclusion Criteria:
Exclusion Criteria:
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This study will enroll individuals with Parkinson's disease who are undergoing clinically indicated subthalamic nucleus deep brain stimulation (STN-DBS). Participants will complete pre-operative neuroimaging using diffusion and structural MRI sequences, as well as standardized neurocognitive assessments. One year following DBS, participants will complete a follow-up cognitive evaluation. The goal is to identify brain microstructural features that predict cognitive decline after DBS.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Recruitment Coordinator | Contact | 843-792-0235 | malakout@musc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Daniel Lench, PhD | Medical University of South Carolina | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of South Carolina | Recruiting | Charleston | South Carolina | 29425 | United States |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |