NCT06960096 is an observational study conducted by the Medical University of South Carolina investigating the neural mechanisms underlying cognitive decline following deep brain stimulation (DBS) of the subthalamic nucleus (STN) in Parkinson's disease patients. This mechanistic study aims to identify how DBS-induced changes in neural connectivity contribute to cognitive decline and how brain microstructure influences these changes[1].
| Attribute | Details |
|---|---|
| NCT Number | NCT06960096 |
| Official Title | A Neural Basis for Cognitive Decline Following Deep Brain Stimulation: A DBS-fMRI Study |
| Sponsor | Medical University of South Carolina |
| Collaborator | National Institute of Neurological Disorders and Stroke (NINDS) |
| NIH Grant | 1K99NS131447-01, 4R00NS131447-03 |
| Intervention | DBS combined with fMRI (observational) |
| Phase | Observational |
| Indication | Parkinson's Disease (post-DBS) |
| Status | Recruiting |
| Enrollment | 55 participants (estimated) |
| Study Duration | August 2025 – April 2028 |
| Location | Medical University of South Carolina, Charleston, SC |
Deep brain stimulation targeting the subthalamic nucleus (STN-DBS) is a well-established surgical intervention for Parkinson's disease patients with disabling motor fluctuations and dyskinesias. While this therapy is highly effective for motor complications, a subset of patients experience cognitive decline following surgery, which can overshadow improvements in quality of life.
The factors contributing to cognitive decline following STN-DBS remain unclear. Current evidence suggests this may result from:
This research seeks to identify how DBS-induced changes in neural connectivity contribute to cognitive decline and how brain microstructure influences these changes.
This is a prospective case-only observational study enrolling Parkinson's disease patients who have already undergone clinically indicated STN-DBS surgery.
Participants will attend two post-DBS visits:
| Visit | Duration | Procedures |
|---|---|---|
| Visit 1 | 3 hours | Informed consent, demographic collection, cognitive assessments |
| Visit 2 | 3 hours | DBS-MRI visit to evaluate brain network connectivity with stimulation ON and OFF |
| Measure | Description | Timeframe |
|---|---|---|
| Executive Function | Composite measure of task-switching, verbal fluency, and inhibitory control using standardized neuropsychological battery | Baseline and 10-14 months post-DBS |
| Measure | Description | Timeframe |
|---|---|---|
| Language | Composite measure of language domain tests | Baseline and 10-14 months post-DBS |
| Attention | Composite measure of attention domain tests | Baseline and 10-14 months post-DBS |
To understand how STN-DBS affects cognitive networks in the brain, potentially leading to cognitive decline in PD patients.
The study investigates three potential mechanisms:
| Mechanism | Description |
|---|---|
| Cognitive Reserve | Pre-existing cognitive reserve may predict post-DBS outcomes |
| Network Interference | Stimulation may interfere with cognitive networks in the frontal cortex |
| Microlesion Effect | Lead placement itself may cause transient or persistent cognitive effects |
Understanding these mechanisms has potential to:
Daniel L. Lench, PhD
Medical University of South Carolina
Charleston, SC
| Contact | Phone | |
|---|---|---|
| Recruitment Coordinator | 843-792-0235 | malakout@musc.edu |
| Daniel Lench, PhD | 843-792-9115 | lenchd@musc.edu |