Cognitive Decline Following Deep Brain Stimulation

NCT05822388 | Recruiting

• 1 other identifier: Pro00125181
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson Disease; Movement Disorders

Outcome Measures

Primary Outcomes (2)

• Change in Cognition

  Change in cognitive performance using a comprehensive neuropsychological battery (e.g., language, executive control, memory, and attention)

  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)

  Within the DBS candidacy evaluation stage (approximately one month prior to deep brain stimulation (DBS))

Secondary Outcomes (2)

• Brain Functional Connectivity

  Within the DBS candidacy evaluation stage (approximately one month prior to deep brain stimulation (DBS))

• Brain Microstructure (DTI)

  Within the DBS candidacy evaluation stage (approximately one month prior to deep brain stimulation (DBS))

Study Arms (2)

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.

Procedure: Deep Brain Stimulation Surgical Procedures as Part of Routine Clinical Care

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.

Interventions

Deep Brain Stimulation Surgical Procedures as Part of Routine Clinical Care 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.

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

Patients with Parkinson's disease (PD) participants who will undergo DBS surgery and healthy controls.

You may qualify if:

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

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

Sponsors & Collaborators

• Medical University of South Carolina: lead

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

RECRUITING

MeSH Terms

Conditions

Parkinson Disease; Movement Disorders

Condition Hierarchy (Ancestors)

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

Study Officials

• Daniel H Lench, PhD

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Daniel H Lench, PhD

CONTACT

843-792-9115; lenchd@musc.edu

Gonzalo J Revuelta, DO

CONTACT

843-792-7262; revuelta@musc.edu

Study Design

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

Study Record Dates

• First Submitted: April 10, 2023
• First Posted: April 20, 2023
• Study Start: April 1, 2023
• Primary Completion: March 31, 2026
• Study Completion: March 31, 2026
• Last Updated: April 29, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)