DBS-fMRI Cognitive Decline Study (NCT06960096): Neural Basis for Cognitive Decl…

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

Trial Information

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:

1. Limited cognitive reserve prior to DBS surgery

2. Stimulation interference with cognitive networks

3. Microlesion effect from lead placement

This 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:

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

Secondary Outcomes

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

1. Identify how DBS-induced changes in neural connectivity contribute to cognitive decline

2. Determine how brain microstructure influences these changes

3. Improve patient selection for DBS surgery

4. Optimize selection of stimulation targets that minimize undesirable cognitive side effects

Scientific Rationale

Potential Mechanisms of Cognitive Decline

The study investigates three potential mechanisms:

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

• Subthalamic Nucleus

• Parkinson’s Disease Cognitive Impairment

• Functional MRI in Neurodegeneration

• STN-DBS Mechanism

Principal Investigator

Daniel L. Lench, PhD Medical University of South Carolina Charleston, SC

Contact Information