Overview
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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["@nct"].
...Overview
Mermaid diagram (expand to render)
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["@nct"].
| 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 |
Background
STN-DBS and Cognitive Decline
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.
Knowledge Gap
The factors contributing to cognitive decline following STN-DBS remain unclear. Current evidence suggests this may result from:
Limited cognitive reserve prior to DBS surgery
Stimulation interference with cognitive networks
Microlesion effect from lead placementThis research seeks to identify how DBS-induced changes in neural connectivity contribute to cognitive decline and how brain microstructure influences these changes.
Study Design
Observational Model
This is a prospective case-only observational study enrolling Parkinson's disease patients who have already undergone clinically indicated STN-DBS surgery.
Study Procedures
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 |
fMRI Protocol
- Participants will undergo fMRI scanning with DBS device turned OFF and ON
- BOLD (blood oxygen level dependent) changes in response to DBS will be evaluated
- Scans and procedures are for research purposes only, not for treatment or diagnostic purposes
Eligibility Criteria
Inclusion Criteria
- Age ≥ 18 years
- Diagnosis of Parkinson's disease per UK Brain Bank diagnostic criteria
- Undergone neurological and neuropsychological evaluation at MUSC Movement Disorder Center
- Selected to undergo 3T-compatible unilateral or bilateral STN-DBS implants
Exclusion Criteria
- Uncorrected visual or hearing impairments
- Pregnant or planning pregnancy during study course
- History of neurological disease other than PD (stroke, major head trauma, epilepsy/seizures)
- Claustrophobia or inability to lie supine in MRI scanner
- COPD with oxygen dependence
- Non-MRI-compatible metal implants (surgical clips/staples, cardiac pacemakers, etc.)
Outcome Measures
Primary Outcomes
| 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 |
Secondary Outcomes
| 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 |
Research Aims
Primary Aim
To understand how STN-DBS affects cognitive networks in the brain, potentially leading to cognitive decline in PD patients.
Secondary Aims
Identify how DBS-induced changes in neural connectivity contribute to cognitive decline
Determine how brain microstructure influences these changes
Improve patient selection for DBS surgery
Optimize selection of stimulation targets that minimize undesirable cognitive side effectsScientific Rationale
Potential Mechanisms of Cognitive Decline
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 |
Clinical Significance
Understanding these mechanisms has potential to:
- Improve surgical outcomes through better patient selection
- Optimize stimulation targeting to avoid cognitive networks
- Personalize DBS therapy based on individual brain microstructure
- Develop predictive biomarkers for cognitive outcome
Related Pages
- [Deep Brain Stimulation Overview](/therapies/deep-brain-stimulation)
- [Subthalamic Nucleus](/anatomy/subthalamic-nucleus)
- [Parkinson's Disease Cognitive Impairment](/diseases/parkinsons-disease-cognitive-impairment)
- [Functional MRI in Neurodegeneration](/technologies/fmri-neurodegeneration)
- [STN-DBS Mechanism](/mechanisms/stn-dbs-mechanism)
Principal Investigator
Daniel L. Lench, PhD
Medical University of South Carolina
Charleston, SC
| Contact | Phone | Email |
|---------|-------|-------|
| Recruitment Coordinator | 843-792-0235 | malakout@musc.edu |
| Daniel Lench, PhD | 843-792-9115 | lenchd@musc.edu |
References
[NCT06960096 ClinicalTrials.gov](https://clinicaltrials.gov/show/NCT06960096)
[NIH Reporter - 1K99NS131447-01](https://reporter.nih.gov/quickSearch/1K99NS131447-01)