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Cognitive Decline Following Deep Brain Stimulation: A DBS-fMRI Study

Recruitingn/aAges 18 Years - anyAllMedical University of South Carolina
NCT06960096 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
Inclusion Criteria: * Subjects above 18 years of age * Individuals with a PD diagnosis as defined by the UK Brain Bank diagnostic criteria for Parkinson's disease (58) which have undergone a neurological and neuropsychological evaluation at MUSCs movement disorder center, and were selected to undergo 3T compatible unilateral or bilateral STN- DBS implants Exclusion Criteria: * 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 that have a history of neurological disease (other than PD) including previous stroke, major head trauma, and epilepsy or seizures. * 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.)
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What it tests

  • DBS combined with fMRI
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Where

1 site
Medical University of South Carolina
Charleston, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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