Recruiting

DBS

Sponsor:

Medical University of South Carolina

Code:

NCT06960096

Conditions

Deep Brain Stimulation

Parkinson Disease

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

DBS combined with fMRI

Study Details

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

Study ID

NCT06960096

Start date

Aug 21, 2025

Status verified date

Oct, 2025

Completion date

Apr 1, 2028

Anticipated

Primary completion date

Apr 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • 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

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 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.)

Study Design

Enrollment

55 participants

Anticipated

Interventions and Outcome Measures

Arms

Patients with Parkinson's Disease undergoing DBS

Interventions

DBS combined with fMRI

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.

Primary outcome measure

  • Change in executive function performance [ Time Frame: Baseline and approximately 1 year (10-14 months) following deep brain stimulation ]

Central Contacts and Locations

Central contacts

Recruitment Coordinator

843-792-0235malakout@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

Oct 14, 2025

Last verified

Oct, 2025

Keywords

  • Brain
  • Parkinsons
  • deep brain stimulation
  • Cognitive

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 2025-10-14.