Device and method for determining spinal cord stimulation efficacy
Inventors
Zuckerman-Stark, Galit • RACHELI, Noam • Ben-Israel, Nir
Assignees
Publication Number
US-12171571-B2
Publication Date
2024-12-24
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 provides a device and method for objectively determining the efficacy of chronic pain treatments, including spinal cord stimulation (SCS). This is achieved by 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 the chronic pain treatment, and thereafter providing a second set of at least one stimulus to obtain second measurements of the physiological parameters. An efficacy of the chronic pain treatment is then determined by applying a classification algorithm on the first and second measurements of the physiological parameters.
The problem being solved relates to the subjective and variable assessment of spinal cord stimulation efficacy in chronic pain patients. Current methods rely on patient self-assessment during a short trial stimulation period, which can be influenced by psychological factors and result in inaccurate evaluations. As many as 20-30% of patients who proceed with permanent SCS implantation do not experience pain relief, while others who might benefit do not receive permanent implantation due to inadequate assessment. The invention addresses this by providing an objective assessment method based on physiological parameter measurements and classification algorithms.
Additionally, the invention aims to objectively monitor and calibrate SCS treatment efficacy over time, detecting desensitization or resistance to therapy. The method allows for periodical evaluation and adjustment of SCS operating parameters to maintain or optimize efficacy by analyzing physiological signals in response to various stimuli and treatment regimens.
Claims Coverage
The patent includes one independent system claim that focuses on a system for calibrating spinal cord stimulation treatment, highlighting processing, sensing, classification, and control of treatment parameters.
System for calibrating spinal cord stimulation treatment by comparative physiological measurement
The system includes a processing module, sensor module, and classifier module and is configured to receive indications of two different SCS treatments characterized by different values of at least one SCS parameter, measure physiological signals in response to each treatment, extract at least two features from these signals, and classify them to determine which treatment correlates with higher efficacy.
Classification based on specific physiological features
The extracted features include ECG signals (Q/R/S/T/P amplitudes and variations), heart rate interval and variability, segment variances, energy of ECG residues, as well as 3-axis accelerometer data including values, averages, and variability.
Selection of optimal SCS parameter value based on efficacy classification
The processing module is further configured to select a value of the SCS parameter that yields the highest efficacy based on the classification results.
Varying the SCS parameter over its dynamic range with continuous or incremental changes
The system varies the SCS parameter across its dynamic range, including making continuous, incremental, or stepwise changes, while holding other parameters fixed.
Classification algorithm comparing measurements to pre-stored data and demographic data use
The classification algorithm compares the measured features to pre-stored datasets from subjects with known SCS efficacies and takes into consideration patient demographic data.
Broad set of physiological features and signals used for classification
Additional features for classification may include photoplethysmograph peaks, galvanic skin response amplitudes, spectral powers in various signals (ECG, EMG, EEG, FEMG), respiratory rate, movement frequency and axes, and other physiological signals such as blood pressure, temperature, pupil diameter, and accelerometer readings.
System optionally includes a spinal cord stimulator device
The system may further comprise an SCS device that delivers the treatment whose efficacy is being evaluated and calibrated.
Output of efficacy comparisons for different SCS treatment parameter settings
The system is configured to display or output the measured efficacies of the first and second SCS treatment parameter settings enabling comparison.
The independent claims cover a system that objectively calibrates spinal cord stimulation treatment parameters by measuring physiological signals in response to different stimulation settings, extracting relevant features, and classifying these to identify optimal treatment parameters that yield higher efficacy. The system incorporates various physiological signal types and can compare results to stored datasets and demographic information to improve classification.
Stated Advantages
Enables objective assessment of chronic pain treatment efficacy, reducing reliance on subjective patient reports.
Facilitates identification of patients who will truly benefit from SCS, reducing false positives and negatives in trial evaluation.
Allows periodical monitoring to detect desensitization or resistance to treatment, enabling timely adjustment.
Provides a method for optimizing SCS parameters by evaluating physiological responses to parameter variations.
Improves treatment efficacy assessment using multiple physiological parameters and advanced classification algorithms.
Documented Applications
Evaluation of spinal cord stimulation efficacy in patients with chronic pain conditions including Failed Back Surgery Syndrome, complex regional pain syndrome, radiculopathy, peripheral vascular disease, neuralgia, neuropathic pain, refractory angina pectoris, and ischemic pain.
Objective assessment during short-term SCS trial to predict efficacy of permanent SCS implantation.
Calibration and adjustment of spinal cord stimulation parameters to find optimal settings for pain relief.
Use of physiological measurements to evaluate treatment effect in scenarios involving at least one stimulus, including painful and non-painful stimuli applied to painful and non-painful areas.
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