Cognitive Decline Following Deep Brain Stimulation
- Conditions
- Movement DisordersParkinson Disease
- Interventions
- Procedure: Deep Brain Stimulation Surgical Procedures as Part of Routine Clinical Care
- Registration Number
- NCT05822388
- Lead Sponsor
- Medical University of South Carolina
- 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. In addition control participants without Parkinson's Disease will be recruited to undergo MRI scanning and cognitive assessments.
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 80
- Subjects above 18 years of age
- Subjects who will undergo DBS surgery as part of their clinical care for PD
- Uncorrected visual or hearing impairments, as indicated by self-report
- Individuals who are pregnant or expect to become pregnant during the course of the study
- Individuals with claustrophobia, or the inability to lie supine position in the MRI scanner
- COPD with oxygen dependence
- Non-MRI compatible metal implants (surgical clips or staples, cardiac pacemakers etc.)
Non-PD Control Participants
Inclusion Criteria:
- Subjects above 18 years of age
- Age matched to participants in PD group
Exclusion Criteria:
- Diagnosis of Parkinsons Disease or other movement disorder
- Untreated neuropsychiatric disorders
- Uncorrected visual or hearing impairments, as indicated by self-report
- Individuals who are pregnant or expect to become pregnant during the course of the study
- Individuals with claustrophobia, or the inability to lie supine position in the MRI scanner
- COPD with oxygen dependence
- Non-MRI compatible metal implants (surgical clips or staples, cardiac pacemakers etc.)
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Parkinson's Disease undergoing DBS Deep Brain Stimulation Surgical Procedures as Part of Routine Clinical Care This study will recruit 55 patients with Parkinson's disease (PD) participants who will undergo DBS surgery and and are scheduled for a pre-DBS neuropsychological evaluation at MUSC.
- Primary Outcome Measures
Name Time Method Brain Microstructure (DKI) Within the DBS candidacy evaluation stage (approximately one month prior to deep brain stimulation (DBS)) Nucleus Basalis of Meynert (NBM) and striatal microstructural integrity using diffusion kurtosis imaging (mean kurtosis; MK)
Change in Cognition From the DBS candidacy evaluation stage (approximately one month prior to deep brain stimulation) until 1 year post surgery Change in cognitive performance using a comprehensive neuropsychological battery (e.g., language, executive control, memory, and attention)
- Secondary Outcome Measures
Name Time Method Brain Microstructure (DTI) Within the DBS candidacy evaluation stage (approximately one month prior to deep brain stimulation (DBS)) Nucleus Basalis of Meynert (NBM) and striatal microstructural integrity using diffusion tensor imaging (mean diffusivity; MD)
Brain Functional Connectivity Within the DBS candidacy evaluation stage (approximately one month prior to deep brain stimulation (DBS)) Functional connectivity in cognitive networks including the Nucleus Basalis of Meynert (NBM) and the striatum
Trial Locations
- Locations (1)
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States