An observational study in Parkinson Disease and Movement Disorders, sponsored by Medical University of South Carolina. Recruiting at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-05-29.
Sponsored by Medical University of South Carolina · Observational
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.
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.
4,573 studies on the registry are indexed under Parkinson Disease; 1,086 are open to participants now.
This study's planned enrollment of 80 is below the median of 96 across 1,085 observational studies indexed under Parkinson Disease.
Browse Parkinson Disease studies →Medical University of South Carolina is the lead sponsor of 874 studies on the registry; 166 are open to participants now.
Of its 131 completed or terminated interventional studies of FDA-regulated products, 104 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
Patients with Parkinson's disease (PD) participants who will undergo DBS surgery and healthy controls.
PD Participants
Inclusion Criteria:
Exclusion Criteria:
Non-PD Control Participants
Inclusion Criteria:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Procedure: Deep Brain Stimulation Surgical Procedures as Part of Routine Clinical Care
This study will recruit 25 healthy controls (age-matched) to serve as a comparison of baseline cognitive and neuroimaging measures.
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.
Change in Cognition
Change in cognitive performance using a comprehensive neuropsychological battery (e.g., language, executive control, memory, and attention)
Time frame: From the DBS candidacy evaluation stage (approximately one month prior to deep brain stimulation) until 1 year post surgery
Brain Microstructure (DKI)
Nucleus Basalis of Meynert (NBM) and striatal microstructural integrity using diffusion kurtosis imaging (mean kurtosis; MK)
Time frame: Within the DBS candidacy evaluation stage (approximately one month prior to deep brain stimulation (DBS))
Brain Functional Connectivity
Functional connectivity in cognitive networks including the Nucleus Basalis of Meynert (NBM) and the striatum
Time frame: Within the DBS candidacy evaluation stage (approximately one month prior to deep brain stimulation (DBS))
Brain Microstructure (DTI)
Nucleus Basalis of Meynert (NBM) and striatal microstructural integrity using diffusion tensor imaging (mean diffusivity; MD)
Time frame: Within the DBS candidacy evaluation stage (approximately one month prior to deep brain stimulation (DBS))
Plan to share: No
No publications or documents are linked to this record.
Started Apr 2023 (actual). Primary completion is estimated for Mar 2027, 47 months after the start.
Of 378 non-industry observational studies under Parkinson Disease, half reached primary completion within 48 months of starting (the median), counting those still running; a quarter within 22 and three quarters within 133. This study's planned 47 months is close to that.
Counting every sponsor, half of 438 studies reached it within 47 months; a quarter within 22 and three quarters within 114.
How these figures are worked out, and which studies are left out of them.
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