Cognitive Decline Following Deep Brain Stimulation

NCT ID: NCT05822388

Last Updated: 2025-04-29

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 80 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-04-01
• Study Completion Date: 2026-03-31

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.

Conditions

Parkinson Disease; Movement Disorders

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Parkinson's Disease undergoing DBS

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.

Deep Brain Stimulation Surgical Procedures as Part of Routine Clinical Care

Intervention Type: PROCEDURE

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.

Healthy Control participants without Parkinson's Disease

This study will recruit 25 healthy controls (age-matched) to serve as a comparison of baseline cognitive and neuroimaging measures.

No interventions assigned to this group

Interventions

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.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Subjects above 18 years of age
• Subjects who will undergo DBS surgery as part of their clinical care for PD

• Subjects above 18 years of age
• Age matched to participants in PD group

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

• 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.)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Medical University of South Carolina

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Daniel H Lench, PhD

Role: PRINCIPAL_INVESTIGATOR

Medical University of South Carolina

Locations

Medical University of South Carolina

Charleston, South Carolina, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Daniel H Lench, PhD

Role: CONTACT

lenchd@musc.edu

843-792-9115

Gonzalo J Revuelta, DO

Role: CONTACT

revuelta@musc.edu

843-792-7262

Facility Contacts

Daniel H Lench, PhD

Role: primary

lenchd@musc.edu

843-792-9115

Other Identifiers

Pro00125181

Identifier Type: -

Identifier Source: org_study_id