Device and method for determining spinal cord stimulation efficacy
Inventors
Zuckerman-Stark, Galit • RACHELI, Noam • Ben-Israel, Nir
Assignees
Publication Number
US-11771369-B2
Publication Date
2023-10-03
Expiration Date
2034-09-29
Interested in licensing this patent?
MTEC can help explore whether this patent might be available for licensing for your application.
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, particularly spinal cord stimulation (SCS). It operates by providing a first set of stimuli to a subject, obtaining first measurements of at least two physiological parameters in response, then providing chronic pain treatment, followed by a second set of stimuli and second measurements of the same physiological parameters. The efficacy of the chronic pain treatment is then determined by applying a classification algorithm to compare the first and second measurements.
The problem being solved addresses the difficulty in accurately assessing pain relief efficacy in subjects with chronic pain due to prolonged brain structural and functional changes and psychological factors that may cause exaggeration or understatement of pain relief. Existing subjective SCS trials often result in 20-30% of patients not experiencing pain relief following permanent implantation despite positive trial indications, or conversely, real beneficiaries being overlooked during trials. The invention provides an objective assessment to overcome this variability and subjectivity.
Additionally, the device and method enable periodic and dynamic assessment of chronic pain treatment efficacy, capturing changes such as desensitization or resistance to treatment over time before setbacks occur. It also allows for adjustment of SCS operating parameters based on objective physiological measurements to identify optimal stimulation settings, rather than relying on patient activity or subjective feedback.
Claims Coverage
The patent includes one independent claim that broadly covers a system for calibrating spinal cord stimulation treatment using physiological measurements and classification algorithms, detailing the system's components and functional features.
System for calibrating spinal cord stimulation treatment
A system comprising a processing module, sensor module, and classifier module configured to receive a first indication that an SCS treatment is being provided, obtain physiological measurements during different SCS parameter values, and determine efficacy using classification algorithms.
Selection of optimal SCS parameter based on classification
The processing module selects a value of an SCS parameter yielding the highest efficacy based on classification outcomes.
Varying SCS parameters over their dynamic range
Changing the SCS parameter across its dynamic range using continuous, incremental, or stepwise changes while fixing other parameters.
Use of multiple physiological features for classification
The system employs multiple physiological features including various photoplethysmograph (PPG), galvanic skin response (GSR), electrocardiogram (ECG), electromyography (EMG), and EEG related parameters for classification.
Incorporation of demographic and pre-stored data in classification
Applying classification algorithms includes comparing physiological measurements to pre-stored datasets from subjects with known SCS efficacies and considers patient demographic data.
Integration with spinal cord stimulation device
The system includes or operates in conjunction with an SCS device to provide stimulation and receive feedback.
The claims define a comprehensive system for objectively calibrating and optimizing spinal cord stimulation therapies using physiological signal measurements, classification algorithms, and demographic data, coupled with a functional SCS device to enhance treatment efficacy.
Stated Advantages
Enables objective assessment of chronic pain treatment efficacy, reducing reliance on subjective patient feedback.
Facilitates periodic monitoring to identify changes in treatment efficacy, such as desensitization or resistance, allowing timely treatment adjustments.
Allows optimization of spinal cord stimulation parameters based on physiological responses, improving treatment personalization.
Improves patient selection for permanent SCS implantation by accurately predicting treatment success during trial phases.
Documented Applications
Evaluating efficacy of spinal cord stimulation treatment in subjects with chronic pain, including assessment during temporary trial stimulation prior to permanent implantation.
Calibration and adjustment of spinal cord stimulation parameters to optimize pain relief effectiveness.
Objective monitoring of chronic pain treatment efficacy over time to detect treatment resistance or changes in patient response.
Use in various chronic pain conditions such as Failed Back Surgery Syndrome, complex regional pain syndrome, radiculopathy, peripheral vascular disease, neuralgia, neuropathic pain, refractory angina pectoris, and ischemic pain.
Interested in licensing this patent?