Method and apparatus for detecting seizures

• US 9,186,105 B2
• Filed: 07/05/2012
• Issued: 11/17/2015
• Est. Priority Date: 07/05/2011
• Status: Active Grant

• Current Assignee: Novela Neurotechnologies, Inc.
• Original Assignee: Brain Sentinel, Inc.
• Inventors: Leininger, James R., Herring, Russell M., Girouard, Michael R., Cavazos, Jose E., Jones, Edward R., Broad, William E.
• Primary Examiner(s): HINDENBURG, MAX F
• Application Number:
  US13/542,596
• Publication Number:
  US 20130012830A1
• Time in Patent Office: 1,230 Days
• US Class Current: 1/1
• CPC Class Codes: A61B 2505/07 Home care
• CPC Class Codes: A61B 5/0004 characterised by the type of physiological signal transmitted
• CPC Class Codes: A61B 5/02055 Simultaneously evaluating both cardiovascular condition and temperature
• CPC Class Codes: A61B 5/296 for electromyography [EMG]
• CPC Class Codes: A61B 5/316 Modalities, i.e. specific diagnostic methods
• CPC Class Codes: A61B 5/318 Heart-related electrical modalities, e.g. electrocardiography [ECG]
• CPC Class Codes: A61B 5/389 Electromyography [EMG]
• CPC Class Codes: A61B 5/4094 Diagnosing or monitoring seizure diseases, e.g. epilepsy
• CPC Class Codes: A61B 5/7246 using correlation, e.g. template matching or determination of similarity
• CPC Class Codes: A61B 5/7267 involving training the classification device
• CPC Class Codes: A61B 5/7271 Specific aspects of physiological measurement analysis A61B5/316, A61B5/349 and A61B5/374 take precedence
• CPC Class Codes: A61B 5/746 Alarms related to a physiological condition, e.g. details of setting alarm thresholds or avoiding false alarms alarms per se G08B
• CPC Class Codes: G16H 40/67 for remote operation

Abstract

A method and apparatus for detecting seizures with motor manifestations including detecting EMG signals, isolating from the EMG signals spectral data for a plurality of frequency bands, and calculating a T-squared value there from. The T-squared values may be detected in real time, such as in a patient'"'"'s home environment, and the T-squared data may be compared to a threshold T-squared value to determine whether an alarm is sent.

Claims

1. A method of detecting seizures comprising:

detecting EMG signals for a time period, the time period comprising a reference period and a monitoring period;

using digital filtering to isolate from the EMG signals spectral data for a plurality of frequencies bands selected from the range of about 2 Hz to about 1000 Hz;

calculating a first T-squared value, the first T-squared value being determined from spectral data for the plurality of frequency ranges, from at least one part of the reference period;

calculating a second T-squared value, the second T-squared value being determined from spectral data for the plurality of frequency ranges, from at least one part of the monitoring period;

comparing the second T-squared value to the first T-squared value; and

determining whether to trigger an alarm condition using said comparison of the first T-squared value to the second T-squared value.

2. The method of claim 1 further comprising:

establishing for a patient a demographic to which said patient most closely resembles; and

setting a threshold T-squared value based on data of acceptable threshold T-squared values for said demographic;

wherein the comparison of the second T-squared value to the first T-squared value includes calculating the difference between said second T-squared value and said first T-squared value;

wherein the determining of whether to trigger an alarm comprises calculation of whether said difference is above said threshold T-squared value.

3. The method of claim 2 wherein the patient is classified based on at least one of criterion, said criterion selected from the group consisting of age, gender, ethnicity, weight, level of body fat, fat content in the arms, fat content in the legs, mid upper arm circumference, fitness level, and level of one or more maximum voluntary contractions.

4. The method of claim 1 further comprising assigning weighting coefficients to different bands among said plurality of frequency bands.

5. The method of claim 4 wherein the assignment of weighting coefficients is based on EMG data collected during said reference period.

6. The method of claim 4 wherein the weighting coefficients are calculated from an inverse matrix of a variance/covariance matrix of T-squared data calculated from data collected during the reference period.

7. The method of claim 6:

wherein the weighting coefficients calculated during the reference period are used to adjust the contribution of spectral data, for each frequency among the plurality of frequency ranges collected during the monitoring period, in said calculation of the second T-squared value;

wherein the plurality of frequency bands comprises a first frequency band from about 300 Hz to about 400 Hz, a second frequency band from about 130 Hz to about 240 Hz, and a third frequency band from about 30 Hz to about 40 Hz; and

wherein the weighting coefficients calculated during the reference period are only used as settings if said weighting coefficients are within an acceptable range.

8. The method of claim 4 wherein the weighting coefficients adjust the contribution of spectral data, for each frequency among the plurality of frequency ranges collected during the monitoring period, in said calculation of the second T-squared value.

9. The method of claim 1 further comprising adjusting an amplitude of EMU signals collected at the start of said reference period, and collecting EMG data for calculation of weighting coefficients during said reference period.

10. The method of claim 9 wherein the weighting coefficients adjust the contribution of spectral data, for each frequency among the plurality of frequency ranges collected during the monitoring period, in said calculation of the second T-squared value.

11. The method of claim 1 further comprising:

calculating a plurality of T-squared values during said monitoring period; and

calculating a standard deviation from said plurality of T-squared values.

12. The method of claim 11 wherein the alarm condition is not triggered unless said standard deviation is above a threshold standard deviation.

13. The method of claim 12 further comprising:

collecting EMG signals while a patient is executing a maximum voluntary contraction and measuring a plurality of T-squared values for different time points during said maximum voluntary contraction;

calculating a reference standard deviation from said plurality of T-squared values for different time points during said maximum voluntary contraction; and

setting said threshold standard deviation based on the reference standard deviation.

14. A method of detecting seizures with motor manifestations comprising:

detecting EMG signals;

using digital filtering to isolate from said EMG signals spectral data for a plurality of frequency bands selected from the range of about 2 Hz to about 1000 Hz;

calculating a first T-squared value from the spectral data;

comparing said first T-squared value to a threshold T-squared value; and

determining whether to trigger an alarm condition using said comparison of the first T-squared value to the threshold T-squared value.

15. The method of claim 14 wherein the threshold T-squared value is a value that is greater than a reference T-squared value.

16. The method of claim 15 further comprising increasing the value of said threshold T-squared if a certain number of false positive events are detected during a given period of time.

17. The method of claim 15 further comprising providing a patient with an I/O device configured to allow the patient to activate said I/O device and identify that an alarm condition was met but no seizure was occurring.

18. The method of claim 17 further comprising increasing the value of said threshold T-squared automatically in response to the activation of said I/O device.

19. The method of claim 15 wherein the reference T-squared value is determined from monitoring a patient during a reference period.

20. The method of claim 19 wherein the threshold T-squared value is greater than the reference T-squared value by a value that is scaled based on the magnitude of a maximum voluntary contraction executed during said reference period.

21. The method of claim 14 further comprising:

collecting EMG signals while a patient is executing a maximum voluntary contraction and measuring a T-squared value; and

setting said threshold T-squared value based on the T-squared value measured while the patient is executing the maximum voluntary contraction.

22. The method of claim 21 wherein the threshold T-squared value is about 100% to about 300% of the T-squared value measured during the maximum voluntary contraction.

23. The method of claim 14 wherein said plurality of frequency bands comprises a first frequency range from about 300 Hz to about 400 Hz, a second frequency range from about 130 Hz to about 240 Hz, and a third frequency range from about 30 Hz to about 40 Hz.

24. The method of claim 14 further comprising:

monitoring a patient during a first reference period;

wherein the threshold T-squared value is greater than a reference T-squared value, the reference T-squared value determined from data obtained during said first reference period;

wherein said first reference period may be executed in the home environment of said patient; and

wherein said first reference period is executed during a time period about when the patient first connects the device.

25. The method of claim 24 further comprising:

monitoring of the patient during a second reference period; and

replacing said reference T-squared value with a second reference T-squared value determined from data obtained during the second reference period.

26. The method of claim 14 wherein the calculating of said first T-squared value comprises assigning weighting coefficients to different bands among said plurality of frequency bands.

27. The method of claim 26 wherein the weighting coefficients adjust the contribution of spectral data from different bands to said first T-squared value.

28. The method of claim 27 wherein the weighting coefficients are factors by which the spectral data is multiplied prior to normalization of the data using a variance/covariance matrix.

31. The method of claim 14 further comprising activation of a device that may be used to abort or attenuate a seizure.

29. A method of detecting seizures comprising:

monitoring an individual by collecting EMG data during a first reference period;

determining a first reference T-squared value from EMG data obtained during said first reference period;

determining a T-squared value while the patient is executing said maximum voluntary contraction;

calculating a difference between said first reference T-squared value and said T-squared value determined while the patient is executing said maximum voluntary contraction;

monitoring an individual by collecting EMG data during a second reference period;

wherein the second reference period is executed in the home environment of the individual;

determining a second reference I-squared value during said second reference period;

setting a threshold T-squared value;

wherein said threshold T-squared value is a value that is greater than the second reference T-squared value by a scaling factor related to said difference between said first reference I-squared value and said T-squared value determined while the patient is executing said maximum voluntary contraction; and

monitoring the patient by collecting EMG data during a time period following said second reference period and in the home environment of the patient.

30. The method of claim 29 wherein said scaling factor is about 50% to about 500% of said difference.

32. An apparatus for detecting seizures, the apparatus comprising:

one or more EMG electrodes capable of providing an EMG signal substantially representing seizure-related muscle activity; and

a processor configured to receive the EMG signal, process the EMG signal to determine whether a seizure may be occurring, and generate an alert if a seizure is determined to be occurring based on the EMG signal;

wherein the processor is capable of processing the EMG signal to determine whether a seizure may be occurring by calculating a T-squared statistical value.

33. The apparatus of claim 32 further comprising an environmental transceiver associated with one or more environmental objects.

34. The apparatus of claim 33 wherein the environmental transceiver is configured to send a signal to a base station that is dependent upon the relative position of the processor and the environmental transceiver.

35. The apparatus of claim 34 wherein the base station comprises a processor capable of processing signals from the environmental transceiver, selecting a template from at least two template files available to the processor, and using the selected template file in processing the EMG signal.

36. The apparatus of claim 32, wherein the apparatus is configured with GPS technology.