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

NCT06960096 | Recruiting

• 3 other identifiers: Pro001424511K99NS131447-014R00NS131447-03
• Study Type: observational
• Target: 55
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Deep Brain Stimulation; Parkinson Disease

Keywords

Brain; Parkinsons; deep brain stimulation; Cognitive

Outcome Measures

Primary Outcomes (1)

• Change in executive function performance

  Cognitive domains known to be affected by subthalamic deep brain stimulation (STN-DBS) will be evaluated using a standardized neuropsycholoical battery. A composite measure of tests within the executive function domain (task-switching, verbal fluency, and inhibitory control) will be assessed as the primary outcome measure for behavior.

  Baseline and approximately 1 year (10-14 months) following deep brain stimulation

Secondary Outcomes (1)

• Change in Language and Attention

  Baseline and approximately 1 year (10-14 months) following deep brain stimulation

Study Arms (1)

Patients with Parkinson's Disease undergoing DBS

Other: DBS combined with fMRI

Interventions

DBS combined with fMRI OTHER

Participants will undergo fMRI scanning while their DBS device is either turned OFF or ON. BOLD (blood oxygen level dependent) changes in response to DBS will be evaluated across PD participants. These scans and DBS procedure will be used for research purposes only and are not for treatment or diagnostic purposes.

Patients with Parkinson's Disease undergoing DBS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This study will enroll individuals with Parkinson's disease who are undergoing clinically indicated subthalamic nucleus deep brain stimulation (STN-DBS). Participants will complete pre-operative neuroimaging using diffusion and structural MRI sequences, as well as standardized neurocognitive assessments. One year following DBS, participants will complete a follow-up cognitive evaluation. The goal is to identify brain microstructural features that predict cognitive decline after DBS.

You may qualify if:

• 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

You may not qualify if:

• 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.)

Sponsors & Collaborators

• Medical University of South Carolina: lead
• National Institute of Neurological Disorders and Stroke (NINDS): collaborator

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

RECRUITING

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Daniel Lench, PhD

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Recruitment Coordinator

CONTACT

843-792-0235; malakout@musc.edu

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2025
• First Posted: May 7, 2025
• Study Start: August 21, 2025
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): April 1, 2028
• Last Updated: October 14, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)