Cognitive Decline Following Deep Brain Stimulation
Study Details
Study Description
Brief Summary
This research study aims to identify MRI-based brain biomarkers that predict an individual's response to Deep Brain Stimulation (DBS). In particular, this study will focus on changes in cognition associated with DBS. A total of 55 participants with Parkinson's Disease planning to undergo DBS will be recruited from MUSCs Clinical DBS Program. Participants will undergo four visits, including a 1-hour screening visit, a 1.5-hour pre-DBS MRI scanning visit, and a 3.5-hour post-DBS cognitive assessment visit.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Detailed Description
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. Understanding how these factors contribute to DBS-induced cognitive decline has the potential to improve patient selection for surgery and optimize the selection of stimulation targets that minimize undesirable cognitive side effects.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Parkinson's Disease undergoing DBS This study will recruit patients with Parkinson disease (PD) participants who will undergo DBS surgery and and are scheduled for a pre-DBS neuropsychological evaluation at MUSC. |
Procedure: Deep Brain Stimulation Surgical Procedures as Part of Routine Clinical Care
Participants in this study will already be undergoing a DBS intervention, however, this is part of their standard clinical care. Pre-surgical DBS candidates that enroll in this study will consent to participate in 1) pre-operative neuroimaging including a high-resolution MRI scan, 2) collection of pre-operative neurocognitive data via chart review and 3) a 1-year postoperative neurocognitive assessment.
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Outcome Measures
Primary Outcome Measures
- Characterize the relationship between brain microstructure and measures of cognition frequently affected by subthalamic deep brain stimulation (STN DBS) [Within the DBS candidacy evaluation stage (approximately one month prior to deep brain stimulation (DBS))]
Lower Nucleus Basalis of Meynert (NBM) and striatal mean kurtosis (MK) will be associated with baseline cognitive performance (e.g., language, executive control, memory, and attention).
- Determine if degeneration of brain microstructure increases vulnerability to DBS related cognitive decline. [From the DBS candidacy evaluation stage (prior to deep brain stimulation surgery) to one year following DBS surgery]
Lower NBM and striatal MK will be associated with greater DBS related cognitive decline 1-year following DBS independent of disease duration and dopaminergic dose (LEDD).
Secondary Outcome Measures
- Characterize the relationship between brain functional connectivity and measures of cognition frequently affected by subthalamic deep brain stimulation (STN DBS) [Within the DBS candidacy evaluation stage (approximately one month prior to deep brain stimulation (DBS))]
Reduced Nucleus Basalis of Meynert (NBM) and frontal-striatal connectivity will be associated with baseline cognitive performance (e.g., language, executive control, memory, and attention).
- Determine if reduced functional connectivity increases vulnerability to DBS related cognitive decline. [From the DBS candidacy evaluation stage (prior to deep brain stimulation surgery) to one year following DBS surgery]
Lower NBM and frontal-striatal connectivity will be associated with greater DBS related cognitive decline 1-year following DBS independent of disease duration and dopaminergic dose (LEDD).
Eligibility Criteria
Criteria
Inclusion Criteria:
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Subjects above 18 years of age
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Subjects who will undergo DBS surgery as part of their clinical care for PD
Exclusion Criteria:
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Uncorrected visual or hearing impairments, as indicated by self-report
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Individuals who are pregnant or expect to become pregnant during the course of the study
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Individuals with claustrophobia, or the inability to lie supine position in the MRI scanner
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COPD with oxygen dependence
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Non-MRI compatible metal implants (surgical clips or staples, cardiac pacemakers etc.)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Medical University of South Carolina | Charleston | South Carolina | United States | 29425 |
Sponsors and Collaborators
- Medical University of South Carolina
Investigators
- Principal Investigator: Daniel H Lench, PhD, Medical University of South Carolina
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- Pro00125181