Status:

RECRUITING

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

Lead Sponsor:

Medical University of South Carolina

Collaborating Sponsors:

National Institute of Neurological Disorders and Stroke (NINDS)

Conditions:

Deep Brain Stimulation

Parkinson Disease

Eligibility:

All Genders

18+ years

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...

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 dyskin...

Eligibility Criteria

Inclusion

  • 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

  • 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.)

Key Trial Info

Start Date :

August 21 2025

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

April 1 2028

Estimated Enrollment :

55 Patients enrolled

Trial Details

Trial ID

NCT06960096

Start Date

August 21 2025

End Date

April 1 2028

Last Update

October 14 2025

Active Locations (1)

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Medical University of South Carolina

Charleston, South Carolina, United States, 29425