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

NCT06960096 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 55

Last updated 2025-10-14

No results posted yet for this study

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

Interventions

OTHER

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.

Sponsors & Collaborators

  • National Institute of Neurological Disorders and Stroke (NINDS)

    collaborator NIH

  • Medical University of South Carolina

    lead OTHER

Principal Investigators

  • Daniel Lench, PhD · Medical University of South Carolina

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-08-21
Primary Completion
2028-04-01
Completion
2028-04-01

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06960096 on ClinicalTrials.gov