Systems and methods for assessing the effectiveness of a therapy including a drug regimen using an implantable medical device
Inventors
Crowder, Tara L. • Wingeier, Brett M. • Morrell, Martha J. • Sun, Felice • Tcheng, Thomas
Assignees
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Publication Number
US-12029581-B2
Publication Date
2024-07-09
Expiration Date
Abstract
Systems and methods rely on feedback from an active medical device or devices (e.g., neurostimulator coupled to sensing and stimulation elements such as electrodes) to assess the effectiveness of a patient's drug regimen. Such reliance may include analyzing characteristics in physiological data acquired by the medical device(s), for example, in the form of responses evoked from the patient by electrical stimulation waveforms. Systems and methods further involved adjusting one or more parameters according to which a combination therapy consisting of at least a drug regimen and an electrical stimulation therapy are delivered to a patient, in an effort to optimize the therapeutic effect of the combination. The adjustments may be automatically by one or more implanted or external hosts working together or alone, and/or with the input of a physician.
Core Innovation
The invention relates to an implantable medical device and method for assessing an effectiveness of an existing drug regimen in a patient. The device is configured to be implanted in the patient's brain and to deliver electrical stimulation therapy through one or more implanted electrodes according to a set of stimulation parameters. The device continuously senses electrical activity of the patient's brain through the electrodes and uses the sensed electrographic signal to support subsequent detection, measurement, and decision-making.
The device detects epileptiform events in an electrographic signal corresponding to the sensed electrical activity. The device also detects evoked responses in the electrographic signal and calculates a measure of the evoked response in response to detection. Further, the device detects a presence of a specified frequency band in the electrographic signal and calculates a power measure of the electrographic signal in the specified frequency in response to the detection.
The device logs information as a function of time, where the logged information comprises one or more of a count of occurrences of the epileptiform events, durations of the epileptiform events, measures of the evoked responses, and power measures of the electrographic signal in the specified frequency. The device determines a tracked metric based on changes in the logged information over a time period within which the existing drug regimen, if effective, would affect the tracked metric, compares the tracked metric to a baseline metric via a criterion, and determines that the existing drug regimen is not effective when the criterion is not satisfied. Responsive to a determination that the existing drug regimen is not effective, the device adjusts the set of stimulation parameters based on a mechanism of action of a drug of the existing drug regimen.
Claims Coverage
The provided independent claims are for an implantable medical device and for a corresponding method. Each independent claim contains the same main inventive feature set: continuous sensing of electrographic signal, detection of epileptiform events and evoked responses, frequency-band presence and power calculation, time-based logging, tracked-metric determination over a drug-relevant time period, baseline-criterion comparison to determine regimen ineffectiveness, and stimulation-parameter adjustment based on a drug mechanism of action.
Assessing effectiveness of an existing drug regimen using logged electrographic measures
An implantable medical device configured for implant in a patient's brain and for assessing an effectiveness of an existing drug regimen to which the patient is subjected, comprising one or more electrodes and a neurostimulator configured to deliver electrical stimulation therapy through the electrodes according to set stimulation parameters.
Continuous sensing and epileptiform event detection with evoked response and frequency-band power measurement
The neurostimulator continuously senses electrical activity through the electrodes, detects epileptiform events in an electrographic signal, detects evoked responses in the electrographic signal and calculates a measure of the evoked response, detects a presence of a specified frequency band in the electrographic signal and calculates a power measure of the electrographic signal in the specified frequency.
Time-based logging, tracked-metric determination versus baseline, and regimen-ineffective determination
The neurostimulator logs information as a function of time, the logged information comprising one or more of a count of occurrences of the epileptiform events, durations of the epileptiform events, measures of the evoked responses, and power measures of the electrographic signal in the specified frequency; determines a tracked metric based on changes in the logged information over a time period within which the existing drug regimen, if effective, would affect the tracked metric; and determines the existing drug regimen is not effective responsive to the tracked metric not satisfying a criterion relative to a corresponding baseline metric.
Stimulation parameter adjustment responsive to drug mechanism of action
Responsive to a determination that the existing drug regimen is not effective, the neurostimulator adjusts the set of stimulation parameters based on a mechanism of action of a drug of the existing drug regimen.
Assessing effectiveness by delivering stimulation, sensing, detecting, logging, comparing to baseline, and adjusting parameters
A method of assessing an effectiveness of an existing drug regimen to which a patient with an implanted medical device is subjected, comprising delivering electrical stimulation therapy to the patient's brain according to a set of stimulation parameters; continuously sensing electrical activity; detecting epileptiform events in an electrographic signal; detecting evoked responses in the electrographic signal and calculating a measure of the evoked response; detecting a presence of a specified frequency band and calculating a power measure of the electrographic signal in the specified frequency; logging information as a function of time including one or more of event counts, event durations, evoked-response measures, and frequency-band power.
Tracked metric determination over a drug-relevant period and baseline-criterion comparison
Determining a tracked metric based on changes in the logged information over a time period within which the existing drug regimen, if effective, would affect the tracked metric; determining the existing drug regimen is not effective responsive to the tracked metric not satisfying a criterion relative to a corresponding baseline metric.
Adjusting stimulation parameters based on drug mechanism of action when regimen is not effective
Responsive to determining that the existing drug regimen is not effective, adjusting the set of stimulation parameters based on a mechanism of action of a drug of the existing drug regimen.
Across both independent claims, the core inventive approach is to continuously sense electrographic activity, quantify epileptiform events and evoked responses, compute frequency-band power, log time-varying measures, derive a tracked metric over a time period tied to expected drug effects, compare against a baseline using a criterion, determine drug regimen ineffectiveness, and adjust stimulation parameters based on a mechanism of action of a drug in the existing drug regimen.
Stated Advantages
Not explicitly described in patent.
Documented Applications
Not explicitly described in patent.
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