Device and method for determining spinal cord stimulation efficacy
Inventors
Zuckerman-Stark, Galit • RACHELI, Noam • Ben-Israel, Nir
Assignees
Publication Number
US-11020052-B2
Publication Date
2021-06-01
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 objectively determining the efficacy of chronic pain treatments, specifically spinal cord stimulation (SCS). It involves providing a first set of stimuli to a subject, obtaining first measurements of at least two physiological parameters in response, then providing a chronic pain treatment and a second set of stimuli, obtaining second measurements, and determining treatment efficacy by applying a classification algorithm to the obtained measurements. This objective assessment is designed to overcome subjective limitations of current pain relief evaluations.
The problem addressed is that existing evaluation of SCS efficacy relies heavily on subjective patient feedback during temporary stimulation trials, which can be influenced by psychological factors leading to exaggeration or understatement of real effectiveness. Up to 20-30% of patients either fail to experience pain relief after permanent implantation despite positive trials or may be incorrectly denied permanent implantation due to failure to recognize benefits during trials.
The device and method enable objective and periodic assessments of chronic pain treatment efficacy by measuring physiological responses to controlled stimuli and applying classification algorithms. This facilitates identification of treatment effectiveness, detection of desensitization or resistance over time before clinical setbacks occur, and enables optimized adjustment of stimulation parameters based on physiological data rather than patient activity or subjective reports.
Claims Coverage
The patent includes independent claims covering a system and a method for calibrating spinal cord stimulation treatment by analyzing physiological signals and features.
System for calibrating spinal cord stimulation treatment
A system comprising a processing module, sensor module, and classifier module that receives indications of different SCS parameter values, conducts physiological signal measurements (including PPG and GSR), extracts at least two features, and classifies them via a classification algorithm to determine which SCS treatment correlates with higher efficacy.
Selection of optimal SCS parameter values
Processing module configured to select a value of the SCS parameter yielding the highest efficacy based on classification results.
Varying SCS parameters over dynamic range
The system varies at least one SCS parameter continuously, incrementally, or stepwise over its dynamic range while holding other parameters fixed to evaluate efficacy.
Use of extensive physiological features
Extraction and classification of a broad set of physiological features from signals including PPG, GSR, ECG, EEG, EMG, respiration, temperature, and movement to assess treatment efficacy.
Classification algorithm comparisons with pre-stored data and demographic considerations
Applying the classification algorithm by comparing measurements to pre-stored data from subjects with known SCS treatment outcomes and incorporating patient demographic data to enhance classification.
Method for calibrating spinal cord stimulation treatment
A method involving delivering first and second SCS treatments characterized by different parameter values, measuring physiological signals, extracting features, classifying them, and outputting which treatment correlates with higher efficacy based on PPG and GSR features.
The claims define a system and method for calibrating spinal cord stimulation treatment by varying stimulation parameters, measuring physiological responses—particularly PPG and GSR signals—extracting features, applying classification algorithms informed by reference data and demographics, and selecting optimal treatment parameters that correlate with higher efficacy.
Stated Advantages
Enables objective assessment of chronic pain treatment efficacy, reducing reliance on subjective patient reports.
Facilitates periodic assessment to detect desensitization or resistance to treatment before clinical setbacks.
Allows adjustment of spinal cord stimulation parameters based on physiological measurements to identify optimal efficacy conditions.
Provides a non-invasive method to predict long-term treatment outcomes from trial treatments.
Documented Applications
Assessment of spinal cord stimulation efficacy for patients suffering from chronic pain, including those with Failed Back Surgery Syndrome, complex regional pain syndrome, radiculopathy, peripheral vascular disease, neuralgia, neuropathic pain, refractory angina pectoris, and ischemic pain.
Evaluation and calibration of temporary or permanent spinal cord stimulation devices.
Adjustment and optimization of stimulation parameters in spinal cord stimulators to maximize treatment efficacy.
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