Evoked Response Scanning with Adaptive Quality Checks
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Solution Overview
Problem
Inaccurate evoked response measurements due to confounding factors such as inconsistent patient conditions and testing equipment conditions affect the decision-making process for stimulation site selection and lead placement in neuromodulation therapy, leading to suboptimal therapy outcomes.
Innovation Solution
A neuromodulation system with an electrostimulator, sensing circuit, and controller circuit that performs quality checks on evoked responses, adjusts the ER sampling routine, and collects responses that satisfy an acceptance criterion to guide lead placement and stimulation setting adjustments.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If multiple stimulation-ER collection tests are performed to collect a large volume of ER recordings from multiple anatomical locations, then the spatial survey comprehensiveness is improved, but the testing time and patient burden increase
Solution Approach 1:
The system performs a quality check on initially collected evoked responses to identify problematic recordings before proceeding with the full spatial survey. This preliminary action prevents wasting time on repeated measurements of poor-quality ERs and allows the system to focus subsequent testing on specific anatomical locations or conditions that require further investigation, thereby reducing overall testing time while maintaining measurement precision
Solution Approach 2:
The system implements a feedback mechanism where the quality check results directly influence the subsequent ER sampling routine. Based on the quality assessment, the system dynamically adjusts which anatomical locations require additional testing and modifies the stimulation parameters for subsequent measurements. This feedback-driven approach optimizes the spatial survey by concentrating resources on areas needing improvement rather than uniformly testing all locations, thus reducing total testing time while preserving measurement accuracy
2Measurement precision
If ER quality check is performed on initially collected ERs, then measurement accuracy is improved, but the processing time and system complexity increase
Solution Approach 1:
The system replaces complex manual quality assessment procedures with an automated computational quality check algorithm. Instead of requiring clinicians to manually evaluate each ER recording for quality, the system automatically analyzes ER characteristics such as signal-to-noise ratio, morphological features, and consistency metrics. This substitution of mechanical/manual processes with automated computational methods improves measurement accuracy while actually reducing system complexity and operational burden
Solution Approach 2:
The quality check mechanism operates autonomously as part of the ER collection process, automatically assessing the quality of collected ERs and feeding results back into the sampling routine without requiring external intervention. The system self-regulates the ER collection process by identifying poor-quality measurements and automatically adjusting subsequent sampling strategies, thereby improving accuracy while minimizing the need for additional complex external quality control systems
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
The system improves the accuracy and consistency of evoked response measurements, enhancing the effectiveness and efficiency of neuromodulation therapy by minimizing perturbations from confounding factors and optimizing lead placement and stimulation settings.
Implementation Method 1
a sensing circuit configured to sense evoked responses (ERs) to electrostimulation via one or more sensing electrodes on the at least one lead
Data Source
AI summary
Systems and methods for collecting evoked responses (ERs), and using the same to guide neuromodulation are disclosed. An exemplary system includes an electrostimulator to provide electrostimulation to a neural target, a sensing circuit to sense ERs, and a controller circuit to collect first ERs sensed from a group of sensing electrodes in response to electrostimulation through first one or more stimulating electrodes. The controller circuit performs a quality check of the first ERs, determine or update an ER sampling routine including timings or an order of performing multiple stimulation and ER collection tests, and sequentially execute the multiple stimulation and ER collection tests, and collect second ERs according to the determined or updated ER sampling routine. When the second ERs satisfy an acceptance criterion, a recommendation can be provided to a user to reposition the lead or to set or adjust a stimulation setting.