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NCT05822388 | RECRUITING | Parkinson Disease

Cognitive Decline Following Deep Brain Stimulation
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.

Condition or disease

Parkinson Disease

Movement Disorders

Intervention/treatment

Deep Brain Stimulation Surgical Procedures as Part of Routine Clinical Care

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 Type : OBSERVATIONAL
Estimated Enrollment : 80 participants
Official Title : A Neural Basis for Cognitive Decline Following Deep Brain Stimulation
Actual Study Start Date : 2023-04-01
Estimated Primary Completion Date : 2026-03-31
Estimated Study Completion Date : 2026-03-31

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: 1
Criteria
PD Participants
  • Inclusion Criteria
    • * Subjects above 18 years of age
    • * Subjects who will undergo DBS surgery as part of their clinical care for PD
    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 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.)
    • Cognitive Decline Following Deep Brain Stimulation

    Location Details

    NCT05822388

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    Locations

    RECRUITING

    United States, South Carolina

    Medical University of South Carolina

    Charleston, South Carolina, United States, 29425