# US 2021/0275093 A1 · Device and method for determining spinal cord stimulation efficacy

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- Number: US 2021/0275093 A1
- Document ID: US20210275093A1
- Status: Published application
- Kind: A1
- Application number: 17/328,617
- Filed: 2021-05-24
- Published: 2021-09-09
- Earliest claimed: 2013-09-29
- Assignees: Medasense Biometrics Ltd.
- Applicants: Medasense Biometrics, Ltd.
- Inventors: Galit Zuckerman-Stark; Noam Racheli; Nir Ben-Israel
- Web page: https://patentgrep.com/patent/US20210275093A1

## CPC

- A61B 5/4848: {Monitoring or testing the effects of treatment, e.g. of medication}
- A61B 5/4824: {Touch or pain perception evaluation (A61B5/4821 takes precedence)}
- A61B 5/4836: {Diagnosis combined with treatment in closed-loop systems or methods (A61B5/0036 takes precedence)}
- A61B 5/7264: {Classification of physiological signals or data, e.g. using neural networks, statistical classifiers, expert systems or fuzzy systems}
- A61N 1/36071: {Pain}
- A61N 1/36135: {using physiological parameters}
- A61N 1/36139: {with automatic adjustment}
- A61N 1/37241: {providing test stimulations}
- A61B 5/0075: {by spectroscopy, i.e. measuring spectra, e.g. Raman spectroscopy, infrared absorption spectroscopy (A61B5/0071 takes precedence)}
- A61B 5/02055: {Simultaneously evaluating both cardiovascular condition and temperature}
- A61B 5/021: Measuring pressure in heart or blood vessels
- A61B 5/02416: {using photoplethysmograph signals, e.g. generated by infrared radiation (A61B5/14552 takes precedence)}
- A61B 5/0533: Measuring galvanic skin response
- A61B 5/08: Measuring devices for evaluating the respiratory organs
- A61B 5/0816: {Measuring devices for examining respiratory frequency (measuring frequency of electric signals G01R23/00)}
- A61B 5/0836: {Measuring rate of CO2 production}
- A61B 5/14542: {for measuring blood gases (A61B5/14551 takes precedence)}
- A61N 1/37247: {User interfaces, e.g. input or presentation means}
- G16H 50/20: for computer-aided diagnosis, e.g. based on medical expert systems
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- A61N: ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY (measurement of bioelectric currents A61B; surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body A61B18/00; anaesthetic apparatus in general A61M; incandescent lamps H01K; infrared radiators for heating H05B)
- G16H: HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA

## 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.

## Claims

### Claim at position 1

1-24. (canceled)

### Claim 25

A system for calibrating spinal cord stimulation (SCS) treatment in a subject, the system comprising a processing module, a sensor module and a classifier module; wherein the processing module is configured to:
receive a first indication from a SCS device that a first SCS treatment is being provided; wherein the first SCS treatment is characterized by a first value of at least one SCS parameter, wherein the first value of the at least one SCS parameter is different from that of a second value of the at least one SCS parameter;
initiate the sensor module to conduct a first measurement of at least one physiological signal in response to the first indication from the SCS device;
wherein the at least one physiological signal comprises at least one of a blood volume signal or a galvanic skin response (GSR) signal;
receive a second indication from the SCS device that a second SCS treatment is being provided; wherein the second SCS treatment is characterized by the second value of the at least one SCS parameter;
initiate the sensor module to conduct a second measurement of the at least one physiological signal in response to the second indication from the SCS device;
initiate the classifier module to, by a non-transitory computer program, extract at least two features from each of the at least one physiological signals obtained from the first and second measurements;
wherein the at least two features comprise blood volume amplitude, blood volume amplitude variation, pulse rate (PR) interval, PR variability, GSR Amplitude, GSR fluctuations, or any combination thereof;
classify the at least two features by applying a classification algorithm thereon; and
output, based on the classification, whether the first SCS treatment or the second SCS treatment correlates with a higher efficacy.

### Claim 26 (depends on 25)

The system according to claim 25, wherein the processing module is further configured to select a value of the one SCS parameter yielding a highest efficacy based on the classification.

### Claim 27 (depends on 25)

The system according to claim 25, wherein varying the SCS parameters comprises changing the SCS parameter over its dynamic range and making at least one of continuous, incremental or step wise changes in the value of the SCS parameter.

### Claim 28 (depends on 25)

The system of claim 25, wherein the remaining of the at least one SCS parameters are fixed while varying the one SCS parameter.

### Claim 29 (depends on 25)

The system of claim 25, wherein the at least one SCS parameter comprises a type of stimulation, stimulation frequency, duration, pulse width, intensity, waveform, wave pattern, signal, amplitude, onset timing, delay, treatment length, treatment period, onset delay, or any combination thereof.

### Claim 30 (depends on 25)

The system of claim 25, wherein applying the classification algorithm further comprises directly or indirectly comparing the first and second measurements to pre-stored data sets of measurements obtained from subjects with known SCS treatment efficacies and taking into consideration demographic data of the patient.

### Claim 31 (depends on 25)

The system of claim 25, further comprising a SCS device.

### Claim 32 (depends on 25)

The system of claim 25, wherein the at least two features further comprise photoplethysmograph (PPG) Peak (P) amplitude, mean PPG Peak (P) amplitude, standard deviation (std) of PPG Peak (P) amplitude, Trough (T) amplitude, mean Trough (T) amplitude, std of Trough (T) amplitude; PPG dicrotic notch (N) amplitude, mean dicrotic notch (N) amplitude, std of dicrotic notch (N) amplitude, PPG peak to peak time intervals, PPG peak to peak interval mean, PPG peak to peak interval std; power spectrum of the PPG peak to peak intervals: VLF Power, LF Power and HF Power; GSR amplitude, GSR mean amplitude, GSR amplitude std; GSR Peak (P) amplitude, mean Peak (P) amplitude and Peak (P) amplitude std; GSR peak to peak time intervals, mean GSR peak to peak time interval; GSR peak to peak time intervals std; Phasic EDA: amplitude, mean amplitude and std of amplitude, Temperature amplitude, mean amplitude and std of amplitude; Temp Peak (P) amplitude, mean amplitude and std of amplitude; Temperature peak to peak time intervals, mean and std (variability) of interval; ECG to PPG Pulse Transition time; PPG to PPG Pulse Transition time; ECG R to R time intervals, mean and std (variability) of intervals; Power of VLF, LF and HF frequency bands of power spectrum of the ECG R to R intervals (heart rate variability); Upper peak amplitude, mean amplitude and STD of amplitude; Respiratory rate, mean rate and std rate; Power of the frequency bands of power spectrum of EMG signal; EMG Power Spectrum Mean frequency; EMG Power Spectrum Highest Peak Frequency; Power of the alpha, beta, gamma, delta, theta frequency bands of power spectrum of EEG/FEMG signal; EMG Power Spectrum Mean frequency; EMG Power Spectral edge frequency; Coherence between 2 or more EEG/FEMG channels; frequency of movement; axis of movement; or any combination thereof.

### Claim 33 (depends on 25)

The system of claim 25, wherein the at least one physiological signal further comprises an electrocardiogram (ECG) signal, a blood pressure signal, a respiration signal, an internal body temperature signal, a skin temperature signal, a electrooculography (EOG) signal, a pupil diameter signal, a electroencephalogram (EEG) signal, a frontalis electromyogram (FEMG) signal, a electromyography (EMG) signal, an electro-gastro-gram (EGG) signal, a laser Doppler velocimetry (LDV) signal, a dynamic light scattering (DLS) signal, a near-infrared spectroscopy (NIRS) signal, a partial pressure of carbon dioxide signal, or an accelerometer reading.

### Claim 34 (depends on 25)

The system of claim 25, wherein the processing module is further configured to display a first efficacy of the first SCS treatment and a second efficacy of the second SCS treatment.

### Claim 35

A system for calibrating spinal cord stimulation (SCS) treatment in a subject, the system comprising a processing module, a sensor module and a classifier module; wherein the processing module is configured to:
receive a first indication from a SCS device that a first SCS treatment is being provided; wherein the first SCS treatment is characterized by a first value of at least one SCS parameter, wherein the first value of the at least one SCS parameter is different from that of a second value of the at least one SCS parameter;
initiate the sensor module to conduct a first measurement of at least one physiological signal in response to the first indication from the SCS device;
wherein the at least one physiological signal comprises at least one of a blood volume signal or movement (accelerometer) signal;
receive a second indication from the SCS device that a second SCS treatment is being provided; wherein the second SCS treatment is characterized by the second value of the at least one SCS parameter;
initiate the sensor module to conduct a second measurement of the at least one physiological signal in response to the second indication from the SCS device;
initiate the classifier module to, by a non-transitory computer program, extract at least two features from each of the at least one physiological signals obtained from the first and second measurements;
wherein the at least two features comprise blood volume amplitude, blood volume amplitude variation, pulse rate (PR) interval, PR variability, accelerometer X, Y, Z, Φ average value, variability, or any combination thereof;
classify the at least two features by applying a classification algorithm thereon; and
output, based on the classification, whether the first SCS treatment or the second SCS treatment correlates with a higher efficacy.

### Claim 36 (depends on 35)

The system according to claim 35, wherein the processing module is further configured to select a value of the one SCS parameter yielding a highest efficacy based on the classification.

### Claim 37 (depends on 35)

The system according to claim 35, wherein varying the SCS parameters comprises changing the SCS parameter over its dynamic range and making at least one of continuous, incremental or step wise changes in the value of the SCS parameter.

### Claim 38 (depends on 35)

The system of claim 35, wherein the remaining of the at least one SCS parameters are fixed while varying the one SCS parameter.

### Claim 39 (depends on 35)

The system of claim 35, wherein the at least one SCS parameter comprises a type of stimulation, stimulation frequency, duration, pulse width, intensity, waveform, wave pattern, signal, amplitude, onset timing, delay, treatment length, treatment period, onset delay, or any combination thereof.

### Claim 40 (depends on 35)

The system of claim 35, wherein applying the classification algorithm further comprises directly or indirectly comparing the first and second measurements to pre-stored data sets of measurements obtained from subjects with known SCS treatment efficacies and taking into consideration demographic data of the patient.

### Claim 41 (depends on 35)

The system of claim 35, further comprising a SCS device.

### Claim 42 (depends on 35)

The system of claim 35, wherein the at least two features further comprise photoplethysmograph (PPG) Peak (P) amplitude, mean PPG Peak (P) amplitude, standard deviation (std) of PPG Peak (P) amplitude, Trough (T) amplitude, mean Trough (T) amplitude, std of Trough (T) amplitude; PPG dicrotic notch (N) amplitude, mean dicrotic notch (N) amplitude, std of dicrotic notch (N) amplitude, PPG peak to peak time intervals, PPG peak to peak interval mean, PPG peak to peak interval std; power spectrum of the PPG peak to peak intervals: VLF Power, LF Power and HF Power; galvanic skin response (GSR) amplitude, GSR mean amplitude, GSR amplitude std; GSR Peak (P) amplitude, mean Peak (P) amplitude and Peak (P) amplitude std; GSR peak to peak time intervals, mean GSR peak to peak time interval; GSR peak to peak time intervals std; Phasic EDA: amplitude, mean amplitude and std of amplitude, Temperature amplitude, mean amplitude and std of amplitude; Temp Peak (P) amplitude, mean amplitude and std of amplitude; Temperature peak to peak time intervals, mean and std (variability) of interval; ECG to PPG Pulse Transition time; PPG to PPG Pulse Transition time; ECG R to R time intervals, mean and std (variability) of intervals; Power of VLF, LF and HF frequency bands of power spectrum of the ECG R to R intervals (heart rate variability); Upper peak amplitude, mean amplitude and STD of amplitude; Respiratory rate, mean rate and std rate; Power of the frequency bands of power spectrum of EMG signal; EMG Power Spectrum Mean frequency; EMG Power Spectrum Highest Peak Frequency; Power of the alpha, beta, gamma, delta, theta frequency bands of power spectrum of EEG/FEMG signal; EMG Power Spectrum Mean frequency; EMG Power Spectral edge frequency; Coherence between 2 or more EEG/FEMG channels; frequency of movement; axis of movement; or any combination thereof.

### Claim 43 (depends on 35)

The system of claim 35, wherein the at least one physiological signal further comprises an electrocardiogram (ECG) signal, a blood pressure signal, a respiration signal, an internal body temperature signal, a skin temperature signal, a electrooculography (EOG) signal, a pupil diameter signal, a electroencephalogram (EEG) signal, a frontalis electromyogram (FEMG) signal, a electromyography (EMG) signal, an electro-gastro-gram (EGG) signal, a laser Doppler velocimetry (LDV) signal, a dynamic light scattering (DLS) signal, a near-infrared spectroscopy (NIRS) signal, a partial pressure of carbon dioxide signal, or an accelerometer reading.

### Claim 44 (depends on 35)

The system of claim 35, wherein the processing module is further configured to display a first efficacy of the first SCS treatment and a second efficacy of the second SCS treatment.