Circuit-Based Deep Brain Stimulation (DBS) represents a paradigm shift in Parkinson's disease treatment, moving from fixed stimulation patterns to adaptive, closed-loop systems that respond to neural circuit activity. This observational study (NCT05658302) conducted by the University of Minnesota investigates how targeted electrical modulation of specific brain circuits affects motor and cognitive function in Parkinson's disease patients.
| Parameter | Value |
|---|---|
| NCT Number | NCT05658302 |
| Status | Recruiting |
| Study Type | Observational |
| Sponsor | University of Minnesota |
| Enrollment | 30 participants (estimated) |
| Start Date | March 28, 2023 |
| Completion Date | March 1, 2028 |
| Location | Minneapolis, Minnesota, United States |
Traditional DBS delivers continuous high-frequency electrical stimulation to brain regions like the subthalamic nucleus or globus pallidus internus. Circuit-Based DBS advances this by:
The trial focuses on understanding:
Circuit-Based DBS represents the next evolution in deep brain stimulation therapy:
Deep brain stimulation has evolved significantly since its FDA approval:
First Generation ( Conventional DBS):
Second Generation ( Adaptive DBS):
Third Generation ( Circuit-Based DBS):
Parkinson's disease involves dysfunction in multiple motor circuits:
Basal Ganglia Circuits:
Cortical Involvement:
This trial maps circuits using:
Recording Methods:
Analysis Approaches:
In Parkinson's disease, the basal ganglia exhibit abnormal oscillatory activity that correlates with motor symptoms:
Beta-Band Activity (13-35 Hz):
Pathological Mechanisms:
Therapeutic Implications:
Tremor-Correlated Oscillations:
Eligibility Assessment:
Preoperative Workup:
| Test | Purpose |
|---|---|
| MRI brain | Structural assessment, target planning |
| CT brain | Precise electrode trajectory planning |
| DaTscan | Confirm dopaminergic deficit |
| Neuropsych battery | Cognitive baseline, risk assessment |
| Medication review | Optimize pre-surgical therapy |
Electrode Implantation:
Postoperative Phases:
Conventional High-Frequency Stimulation:
Low-Frequency Stimulation:
Burst Stimulation:
Signal Processing Pipeline:
Control Strategies:
Targeted Outcomes:
Specific Assessments:
Cognitive Effects:
Mood and Behavior:
PDQ-39 Domains:
Next-Generation Systems:
Sensing Capabilities:
Machine Learning Integration:
Personalized Medicine:
The observational design allows:
Data Collection:
Patient Selection:
Recording Sites:
Analysis:
The trial studies:
Motor Preparation:
Circuit Changes:
Motor and cognitive circuits interact:
N-Back Task:
Circuit Integration:
Circuit-based approaches enable:
Target Selection:
Parameter Optimization:
Circuit-based DBS may lead to:
Closed-Loop Systems:
Cognitive Treatment:
Established safety considerations:
Surgical Risks:
Stimulation Effects:
Patient monitoring includes:
This trial advances:
Circuit-based approaches may apply to: