Electrode Selection for Sub-threshold Neuromodulation Therapy
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Solution Overview
Problem
Current neuromodulation systems face challenges in optimizing sub-threshold therapy delivery, as the lack of paresthesia makes it difficult for clinicians to determine if the therapy is efficacious, requiring multiple reprogramming sessions to identify optimal electrode and parameter combinations, which can take days or weeks.
Innovation Solution
A method and system that determine anodic and cathodic perception thresholds for each electrode set, calculate ratios, and select effective electrode sets based on these thresholds and paresthesia maps to deliver sub-threshold electrical energy, ensuring therapy effectiveness without causing discomfort.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If sub-threshold electrical energy is delivered to modulate neural tissue, then therapy efficacy is improved, but it becomes difficult to determine if the therapy is efficacious due to lack of paresthesia
Solution Approach 1:
The system uses perception threshold testing as a feedback mechanism to objectively determine therapy efficacy. By measuring the ratio between anodic and cathodic perception thresholds, the system provides quantitative feedback about which electrode configurations are effectively modulating neural tissue, even in the absence of patient-reported paresthesia during sub-threshold delivery.
Solution Approach 2:
The system performs preliminary perception threshold mapping and ratio calculations before delivering sub-threshold therapy. This preliminary action identifies optimal electrode configurations and parameters based on individual patient characteristics, ensuring therapy is delivered through electrodes proven to effectively modulate the target neural tissue.
2Reliability
If multiple reprogramming sessions are conducted to identify optimal electrode and parameter combinations, then therapy optimization is achieved, but time consumption increases significantly
Solution Approach 1:
The system performs preliminary perception threshold mapping and ratio calculations during the initial programming session. By pre-identifying optimal electrode configurations and parameters based on individual patient perception characteristics, the system eliminates the need for multiple iterative reprogramming sessions, reducing total programming time from days or weeks to a single session.
Solution Approach 2:
The system uses the patient's own perception threshold responses to automatically determine optimal therapy parameters. The objective measurement of perception threshold ratios provides self-directed guidance for parameter selection, reducing the need for extensive clinician trial-and-error programming and multiple follow-up adjustment sessions.
3Measurement precision
If super-threshold electrical energy is delivered to elicit paresthesia for threshold determination, then perception thresholds can be measured, but patient discomfort increases
Solution Approach 1:
The system applies electrical energy at super-threshold levels only temporarily and partially during the perception threshold testing phase, not during actual therapy delivery. By limiting super-threshold exposure to brief measurement periods and using the lowest necessary amplitude to elicit perception, the system obtains precise threshold data while minimizing patient discomfort.
Solution Approach 2:
Perception threshold measurements using super-threshold energy are performed as a preliminary step before sub-threshold therapy delivery. Once thresholds are determined and optimal electrode configurations are identified, therapy is delivered at sub-threshold levels that do not cause discomfort, separating the measurement phase from the therapy phase.
Data Source
AI summary
A neuromodulation system and method of providing sub-threshold therapy to a patient. An anodic perception threshold of super-threshold electrical energy and a cathodic perception threshold of super-threshold electrical energy are determined for a plurality of electrode sets. A ratio between the anodic perception threshold and the cathodic perception threshold is calculated for each of the electrode sets. An effective electrode set is selected based on the ratio between the anodic perception threshold and the cathodic perception threshold.