Recruiting

Deep Brain Stimulation

Sponsor:

Medical University of South Carolina

Code:

NCT05822388

Conditions

Parkinson Disease

Movement Disorders

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Deep Brain Stimulation Surgical Procedures as Part of Routine Clinical Care

Study Details

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

Study ID

NCT05822388

Start date

Apr 1, 2023

Status verified date

May, 2026

Completion date

Mar 31, 2027

Anticipated

Primary completion date

Mar 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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.)

Study Design

Enrollment

80 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

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

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.

Primary outcome measure

  • Change in Cognition [ Time Frame: From the DBS candidacy evaluation stage (approximately one month prior to deep brain stimulation) until 1 year post surgery ]
  • Brain Microstructure (DKI) [ Time Frame: Within the DBS candidacy evaluation stage (approximately one month prior to deep brain stimulation (DBS)) ]

Central Contacts and Locations

Central contacts

Daniel H Lench, PhD

843-792-9115lenchd@musc.edu

Gonzalo J Revuelta, DO

843-792-7262revuelta@musc.edu

Locations

Medical University of South Carolina

Recruiting

Charleston, South Carolina, United States, 29425

Contacts

Daniel H Lench, PhD

843-792-9115lenchd@musc.edu

More Information

Sponsor

Medical University of South Carolina

Last update posted

May 29, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Medical University of South Carolina on 2026-05-29.