Device and method for determining spinal cord stimulation efficacy
Inventors
Zuckerman-Stark, Galit • RACHELI, Noam • Ben-Israel, Nir
Assignees
Publication Number
US-10231666-B2
Publication Date
2019-03-19
Expiration Date
2034-09-29
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Abstract
Device and method for determining an efficacy of chronic pain treatment including providing a first set of at least one stimulus to a subject, obtaining first measurements of at least two physiological parameters in response to the first set of at least one stimulus, providing chronic pain treatment to the subject, providing a second set of at least one stimulus to the subject, obtaining second measurements of the at least two physiological parameters in response to the second set of at least one stimulus; and determining an efficacy of the chronic pain treatment by applying a classification algorithm on the first and second measurements of the at least two physiological parameters.
Core Innovation
The invention relates to a device and method for determining the efficacy of chronic pain treatments, particularly spinal cord stimulation (SCS). The method involves providing a first set of at least one stimulus to a subject, obtaining first measurements of at least two physiological parameters in response, then providing a chronic pain treatment, followed by a second set of at least one stimulus and obtaining second measurements of the same physiological parameters. The efficacy is determined by applying a classification algorithm on these measurements.
The problem addressed is the difficulty and subjectivity in assessing the efficacy of spinal cord stimulation for chronic pain patients. Current methods rely on patient self-reporting during trial stimulation periods, which can be unreliable due to psychological factors affecting perception and possible desensitization over time. As many as 20–30% of patients do not experience pain relief following permanent implantation despite positive trial results, while others who might benefit are overlooked.
The disclosed device and method enable an objective, physiological signal based assessment of chronic pain treatment efficacy. This can aid in predicting long-term treatment outcomes based on trial treatments and assist in periodic evaluation to detect loss of efficacy or resistance. Furthermore, the method facilitates calibration of SCS parameters to optimize treatment efficacy by analyzing physiological responses, which can improve treatment personalization and timing of interventions like battery replacement.
Claims Coverage
The patent includes one independent system claim focused on a system for assessing SCS treatment efficacy by measuring physiological signals and applying classification algorithms.
System configured for sequential stimulus and measurement
The system includes a processing module that receives indications from a stimulus evoking device to provide first and second sets of stimuli and from a SCS device to indicate when treatment is applied, and initiates physiological signal measurements accordingly.
Physiological signal acquisition and classification
A sensor module non-invasively senses physiological signals including photoplethysmograph (PPG) and galvanic skin response (GSR) signals, from which at least two features such as PPG amplitude, pulse rate interval, and GSR fluctuations are extracted and classified using a classification algorithm.
Use of pre-stored datasets for efficacy comparison
The classification algorithm includes directly or indirectly comparing measurement results to pre-stored datasets from subjects with known SCS treatment efficacies to determine treatment efficacy.
Incorporation of demographic and trial data for long-term efficacy prediction
The system considers patient demographic data and provides an efficacy score indicative of long-term SCS treatment outcomes based on trial treatment efficacy, enabling recommendations about permanent implantation.
Support for various stimulation types and signals
The system supports various stimulus types (painful, non-painful, thermal, mechanical, electrical, etc.) and physiological signals beyond PPG and GSR, including ECG, EEG, EMG, blood pressure, and others, with corresponding extracted features used in classification.
The claims define a system that objectively assesses spinal cord stimulation treatment efficacy by sequential stimulus application and physiological signal measurement, using feature extraction and classification that compares to known datasets, incorporates demographic data, and supports various stimuli and physiological signals to predict treatment success and inform clinical decisions.
Stated Advantages
Enables objective assessment of chronic pain treatment efficacy, reducing reliance on subjective patient reports.
Facilitates prediction of long-term spinal cord stimulation treatment outcomes based on trial treatments.
Allows periodic evaluation to detect desensitization or resistance to treatment for timely adjustments.
Supports optimization of spinal cord stimulation parameters by analyzing physiological responses, improving treatment personalization.
Documented Applications
Assessing the efficacy of chronic pain treatments including spinal cord stimulation (SCS) trials prior to permanent implantation.
Periodic evaluation of treatment efficacy to detect changes requiring treatment adjustments or surgical interventions.
Calibration and adjustment of spinal cord stimulation parameters to achieve optimal pain relief.
Objective measurement of physiological responses to various pain-related stimuli (painful and non-painful, of different modalities) in patients suffering chronic pain.
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