Method for automated analysis of submaximal F-waves

• US 8,326,410 B2
• Filed: 11/02/2005
• Issued: 12/04/2012
• Est. Priority Date: 02/17/2004
• Status: Expired due to Fees

• Current Assignee: Neurometrix, Inc.
• Original Assignee: Neurometrix, Inc.
• Inventors: Kong, Xuan, Bansal, Pansy, Gozani, Shai N.
• Primary Examiner(s): TOWA, RENE T
• Application Number:
  US11/265,027
• Publication Number:
  US 20060217631A1
• Time in Patent Office: 2,589 Days
• Field of Search: 600/547, 600/554, 600/557, 600/595
• US Class Current: 600/547
• CPC Class Codes: A61B 5/24 Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
• CPC Class Codes: A61B 5/389 Electromyography [EMG]
• CPC Class Codes: A61B 5/4041 Evaluating nerves condition

Abstract

A novel submaximal F-wave acquisition and analysis system that employs computational intelligence to set up submaximal F-wave acquisition conditions and to extract submaximal F-wave features automatically, without operator intervention.

Claims

1. A method for acquiring and analyzing F-waves under a submaximal stimulation condition, the method comprising:

(i) applying a series of stimuli of variable intensity to a nerve using a stimulation electrode;

(ii) recording a series of early responses;

(iii) determining a submaximal stimulation level for F-wave acquisition and analysis, wherein the submaximal stimulation level is an intensity level which is approximately fifty percent of a maximal stimulus intensity, and further wherein the maximal stimulus intensity is an intensity level at which additional increases in stimulus intensity do not lead to further increases in the amplitude of an evoked response;

(iv) applying a series of stimuli to a nerve using the stimulation electrode, wherein the series of stimuli are applied at the submaximal stimulation level;

(v) recording a series of late responses;

(vi) regulating the submaximal stimulation level and acquisition condition based on late response features;

(vii) analyzing late response to regulate a processing condition of F-wave features; and

(viii) characterizing F-wave features with trace-by-trace and/or total waveform set analysis.

2. A method according to claim 1 wherein the determination of the submaximal stimulation level is based on an early wave feature space.

3. A method according to claim 2 wherein the feature space is based on a translation of an early wave into a feature space.

4. A method according to claim 3, wherein the translation comprises the step of determining the local minima, local maxima, first deflection from baseline, and subsequent crossings of baseline level for the individual early responses.

5. A method according to claim 3, wherein the translation comprises the step of determining the local minima, local maxima, and zero crossings of the first and second order derivatives of the early responses.

6. A method according to claim 3, wherein the translation comprises the step of determining linear translation of the early responses.

7. A method according to claim 3, wherein the translation comprises the step of determining nonlinear translation of the early responses.

8. A method according to claim 2 wherein the determination of the submaximal stimulation level is based on one or more features as the result of one or more translation.

9. A method according to claim 8 wherein the determination further comprises the step of determining reference feature values in the feature space.

10. A method according to claim 8 wherein the determination further comprises the step of determining target feature values associated with a target submaximal stimulation level.

11. A method according to claim 8 wherein the determination further comprises the step of determining a target stimulation intensity based on feature space characteristics.

12. A method according to claim 8 wherein the determination further comprises the step of determining of target stimulation intensity based on at least one selected from the group consisting of prediction, smoothing, interpolation, and estimation.

13. A method according to claim 1 wherein the late response feature comprises at least one selected from the group consisting of:

F-wave persistence, F-wave amplitude and its relationship with available dynamic range, F-wave morphology, A-wave presence, artifacts commonly observed in late waves, and baseline fluctuation.

14. A method according to claim 1 wherein the step of regulating comprises the actions of changing at least one stimulation and acquisition condition selected from the group consisting of:

stimulation intensity, stimulation frequency, stimulation duration, late wave acquisition gain, digital waveform amplitude representation resolution, analog-to-digital bits per sample, digital waveform time scale representation resolution, sampling interval, analog and digital filter settings for conditioning late wave before display and feature analysis, and data acquisition window starting time and duration.

15. A method according to claim 1 wherein the step of regulating comprises the detection and localization of A-wave components.

16. A method according to claim 1 wherein the step of regulating comprises:

(a) masking A-wave segments of late responses from F-wave feature analysis;

(b) removing A-wave components from late responses prior to F-wave feature analysis; and

(c) altering F-wave feature analysis method settings to minimize the interference of A-wave components.

17. A method according to claim 1 wherein applying a series of stimuli of variable intensity to a nerve comprises applying a series of stimuli of increasing intensity to a nerve.

18. A method according to claim 1 wherein determining a submaximal stimulation level for F-wave acquisition and analysis comprises determining the submaximal stimulation intensity based on a stimulus response curve and a target ratio between the submaximal and supramaximal early response magnitudes.

19. A method according to claim 1 wherein applying a series of stimuli of submaximal intensity to a nerve comprises applying a series of stimuli of fixed intensity at the submaximal level to the nerve.

20. A method according to claim 1 wherein regulating the submaximal stimulation level and acquisition condition based on late response features comprises detecting possible A-wave and H-reflex responses and altering the stimulation condition to suppress or enhance such responses.

21. A method according to claim 20 wherein detecting possible A-wave and H-reflex responses and altering the stimulation condition to suppress the A-wave and H-reflex responses from the late responses comprises applying a series of stimuli with an increased level of intensity capable of suppressing axon-reflex and/or H-reflex in the late response.

22. A method according to claim 1 wherein analyzing late responses to regulate the processing condition of F-wave features comprises excluding A-wave and H-reflex response segments from the late wave and extracting F-wave parameters from the remaining late wave segments.

23. A method according to claim 1 wherein determining a submaximal stimulation level for F-wave acquisition and analysis comprises determining the submaximal stimulation intensity based on a percentage or magnitude reduction of a supramaximal stimulation intensity.

24. A method according to claim 1 wherein determining a submaximal stimulation level for F-wave acquisition and analysis comprises determining the submaximal stimulation intensity based on a percentage or magnitude reduction of a supra maximal early response magnitude.

25. A method according to claim 1 wherein applying a series of stimuli of variable intensity to a nerve comprises applying a series of stimuli of intensities that are determined based on an efficient search algorithm.

26. A method for diagnosing a disorder in a patient comprising:

(i) applying a series of stimuli of variable intensity to a nerve using a stimulation electrode;

(ii) recording a series of early responses;

(iii) determining a submaximal stimulation level for F-wave acquisition and analysis, wherein the submaximal stimulation level is an intensity level which is approximately fifty percent of a maximal stimulus intensity, and further wherein the maximal stimulus intensity is an intensity level at which additional increases in stimulus intensity do not lead to further increases in the amplitude of an evoked response;

(iv) applying a series of stimuli to a nerve using the stimulation electrode, wherein the series of stimuli are applied at the submaximal stimulation level;

(v) recording a series of late responses;

(vi) regulating the submaximal stimulation level and acquisition condition based on late response features;

(vii) analyzing late responses to regulate the processing condition of F-wave features;

(viii) characterizing F-wave features with trace-by-trace and/or total waveform set analysis; and

(ix) comparing F-wave characteristics based on the submaximal late responses with those of normal character and those of known disorder.

27. A system for analyzing F-waves acquired under submaximal stimulation conditions, the system comprising:

(i) a stimulation electrode;

(ii) a stimulation circuit connected to the stimulation electrode for applying a series of stimuli to a nerve;

(iii) a detection electrode;

(iv) a detection circuit connected to the detection electrode; and

(v) an analyzer connected to the detection circuit and stimulation circuit and adapted to conduct submaximal F-wave analysis by;

(a) recording a series of early responses detected by the detection circuit and evoked by stimuli with variable intensities delivered by the stimulation circuit;

(b) determination of a submaximal stimulation level based on an early response feature space, wherein the submaximal stimulation level is an intensity level which is approximately fifty percent of a maximal stimulus intensity, and further wherein the maximal stimulus intensity is an intensity level at which additional increases in stimulus intensity do not lead to further increases in the amplitude of an evoked response;

(c) recording a series of late responses detected by the detection circuit and evoked by submaximal stimulation;

(d) regulating the stimulation circuit by the analyzer based on late response features;

(e) recording and analyzing a series of late responses detected by the detection circuit; and

(f) altering the F-wave analysis setup and late response traces; and

(vi) apparatus for characterizing the F-wave features.

28. A method for acquiring submaximal F-wave features, comprising:

(i) determining a submaximal stimulation level for submaximal F-wave acquisition, wherein the submaximal stimulation level is an intensity level which is approximately fifty percent of a maximal stimulus intensity, and further wherein the maximal stimulus intensity is an intensity level at which additional increases in stimulus intensity do not lead to further increases in the amplitude of an evoked response;

(ii) acquiring and analyzing late waves, using a stimulation electrode and a detection electrode, under submaximal stimulation conditions;

(iii) modifying the stimulation conditions based on real-time monitoring of the late wave analysis outcomes; and

(iv) extracting and comparing F-wave features under alternative stimulation conditions.

29. Apparatus for acquiring submaximal F-wave features, comprising:

(i) a unit for determining a submaximal stimulation level for submaximal F-wave acquisition, wherein the submaximal stimulation level is an intensity level which is approximately fifty percent of a maximal stimulus intensity, and further wherein the maximal stimulus intensity is an intensity level at which additional increases in stimulus intensity do not lead to further increases in the amplitude of an evoked response;

(ii) a unit for acquiring and analyzing late waves under submaximal stimulation conditions;

(iii) a unit for modifying the stimulation conditions based on real-time monitoring of the late wave analysis outcomes; and

(iv) a unit for extracting and comparing F-wave features under alternative stimulation conditions.

30. A method for acquiring and analyzing F-waves under a submaximal stimulation condition, the method comprising:

(i) applying a series of stimuli of variable intensity to a nerve using a stimulation electrode;

(ii) recording a series of early responses;

(iii) determining a submaximal stimulation level for F-wave acquisition and analysis wherein the submaximal stimulation level is an intensity level which is approximately fifty percent of a maximal stimulus intensity, and further wherein the maximal stimulus intensity is an intensity level at which additional increases in stimulus intensity do not lead to further increases in the amplitude of an evoked response;

(iv) applying a series of stimuli of submaximal intensity to a nerve using the stimulation electrode;

(v) recording a series of late responses;

(vi) regulating the submaximal stimulation and acquisition condition based on late response features;

(vii) analyzing late response to regulate a processing condition of F-wave features; and

(viii) characterizing F-wave features with trace-by-trace and/or total waveform set analysis;

wherein the determination of the submaximal stimulation level is based on an early wave feature space;

wherein the feature space is based on a translation of an early wave into a feature space; and

wherein the translation comprises the step of determining the local minima, local maxima, first deflection from baseline, and subsequent crossings of baseline level for the individual early responses.

31. A method for acquiring and analyzing F-waves under a submaximal stimulation condition, the method comprising:

(i) applying a series of stimuli of variable intensity to a nerve using a stimulation electrode;

(ii) recording a series of early responses;

(iii) determining a submaximal stimulation level for F-wave acquisition and analysis wherein the submaximal stimulation level is an intensity level which is approximately fifty percent of a maximal stimulus intensity, and further wherein the maximal stimulus intensity is an intensity;

level at which additional increases in stimulus intensity do not lead to further increases in the amplitude of an evoked response

(iv) applying a series of stimuli of submaximal intensity to a nerve using the stimulation electrode;

(v) recording a series of late responses;

(vi) regulating the submaximal stimulation and acquisition condition based on late response features;

(vii) analyzing late response to regulate a processing condition of F-wave features; and

(viii) characterizing F-wave features with trace-by-trace and/or total waveform set analysis;

wherein the determination of the submaximal stimulation level is based on an early wave feature space;

wherein the feature space is based on a translation of an early wave into a feature space; and

wherein the translation comprises the step of determining the local minima, local maxima, and zero crossings of the first and second order derivatives of the early responses.

32. A method for acquiring and analyzing F-waves under a submaximal stimulation condition, the method comprising:

(i) applying a series of stimuli of variable intensity to a nerve using a stimulation electrode;

(ii) recording a series of early responses;

(iii) determining a submaximal stimulation level for F-wave acquisition and analysis wherein the submaximal stimulation level is an intensity level which is approximately fifty percent of a maximal stimulus intensity, and further wherein the maximal stimulus intensity is an intensity level at which additional increases in stimulus intensity do not lead to further increases in the amplitude of an evoked response;

(iv) applying a series of stimuli of submaximal intensity to a nerve using the stimulation electrode;

(v) recording a series of late responses;

(vi) regulating the submaximal stimulation and acquisition condition based on late response features;

(vii) analyzing late response to regulate a processing condition of F-wave features; and

(viii) characterizing F-wave features with trace-by-trace and/or total waveform set analysis;

wherein the step of regulating comprises;

(a) masking A-wave segments of late responses from F-wave feature analysis;

(b) removing A-wave components from late responses prior to F-wave feature analysis; and

(c) altering F-wave feature analysis method settings to minimize the interference of A-wave components.

33. A method for acquiring and analyzing F-waves under a submaximal stimulation condition, the method comprising:

(i) applying a series of stimuli of variable intensity to a nerve using a stimulation electrode;

(ii) recording a series of early responses;

(iii) determining a submaximal stimulation level for F-wave acquisition and analysis wherein the submaximal stimulation level is an intensity level which is approximately fifty percent of a maximal stimulus intensity, and further wherein the maximal stimulus intensity is an intensity level at which additional increases in stimulus intensity do not lead to further increases in the amplitude of an evoked response;

(iv) applying a series of stimuli of submaximal intensity to a nerve using the stimulation electrode;

(v) recording a series of late responses;

(vi) regulating the submaximal stimulation and acquisition condition based on late response features;

(vii) analyzing late response to regulate a processing condition of F-wave features; and

(viii) characterizing F-wave features with trace-by-trace;

wherein regulating the submaximal stimulation and acquisition condition based on late response features comprises detecting possible A-wave and H-reflex responses and altering the stimulation condition to suppress or enhance such responses.

34. A method according to claim 33 wherein detecting possible A-wave and H-reflex responses and altering the stimulation condition to suppress the A-wave and H-reflex responses from the late responses comprises applying a series of stimuli with an increased level of intensity capable of suppressing axon-reflex and/or H-reflex in the late response.

35. A method according to claim 33 wherein analyzing late responses to regulate the processing condition of F-wave features comprises excluding A-wave and H-reflex response segments from the late wave and extracting F-wave parameters from the remaining late wave segments.

36. A method for acquiring and analyzing F-waves under a submaximal stimulation condition, the method comprising:

(i) applying a series of stimuli of variable intensity to a nerve using a stimulation electrode;

(ii) recording a series of early responses;

(iii) determining a submaximal stimulation level for F-wave acquisition and analysis, wherein the submaximal stimulation level is an intensity level which is approximately fifty percent of a maximal stimulus intensity, and further wherein the maximal stimulus intensity is an intensity level at which additional increases in stimulus intensity do not lead to further increases in the amplitude of an evoked response;

(iv) applying a series of stimuli to a nerve, using the stimulation electrode, wherein the series of stimuli are applied at the submaximal stimulation level;

(v) recording a series of late responses;

(vi) regulating the submaximal stimulation level and acquisition condition based on late response features;

(vii) analyzing late response to regulate a processing condition of F-wave features; and

(viii) characterizing F-wave features with trace-by-trace and/or total waveform set analysis.

37. A method for diagnosing a disorder in a patient comprising:

(i) applying a series of stimuli of variable intensity to a nerve using a stimulation electrode;

(ii) recording a series of early responses;

(iii) determining a submaximal stimulation level for F-wave acquisition and analysis, wherein the submaximal stimulation level is an intensity level which is approximately fifty percent of a maximal stimulus intensity, and further wherein the maximal stimulus intensity is an intensity level at which additional increases in stimulus intensity do not lead to further increases in the amplitude of an evoked response;

(iv) applying a series of stimuli to a nerve, using the stimulation electrode, wherein the series of stimuli are applied at the submaximal stimulation level;

(v) recording a series of late responses;

(vi) regulating the submaximal stimulation level and acquisition condition based on late response features;

(vii) analyzing late responses to regulate the processing condition of F-wave features;

(viii) characterizing F-wave features with trace-by-trace and/or total waveform set analysis; and

(ix) comparing F-wave characteristics based on the submaximal late responses with those of normal character and those of known disorder.

38. A system for analyzing F-waves acquired under submaximal stimulation conditions, the system comprising:

(i) a stimulation electrode;

(ii) a stimulation circuit connected to the stimulation electrode for applying a series of stimuli to a nerve;

(iii) a detection electrode;

(iv) a detection circuit connected to the detection electrode; and

(v) an analyzer connected to the detection circuit and stimulation circuit and adapted to conduct submaximal F-wave analysis by;

(a) recording a series of early responses detected by the detection circuit and evoked by stimuli with variable intensities delivered by the stimulation circuit;

(b) determination of a submaximal stimulation level based on an early response feature space, wherein the submaximal stimulation level is an intensity level which is less than a maximal stimulus intensity and less than a near maximal stimulus intensity, wherein the submaximal stimulation level is an intensity level which is approximately fifty percent of a maximal stimulus intensity, and further wherein the maximal stimulus intensity is an intensity level at which additional increases in stimulus intensity do not lead to further increases in the amplitude of an evoked response;

(c) recording a series of late responses detected by the detection circuit and evoked by submaximal stimulation;

(d) regulating the stimulation circuit by the analyzer based on late response features;

(e) recording and analyzing a series of late responses detected by the detection circuit; and

(f) altering the F-wave analysis setup and late response traces; and

(vi) apparatus for characterizing the F-wave features.

39. A method for acquiring submaximal F-wave features, comprising:

(i) determining a submaximal stimulation level for submaximal F-wave acquisition, wherein the submaximal stimulation level is an intensity level which is less than a maximal stimulus intensity and less than a near maximal stimulus intensity, wherein the submaximal stimulation level is an intensity level which is approximately fifty percent of a maximal stimulus intensity, and further wherein the maximal stimulus intensity is an intensity level at which additional increases in stimulus intensity do not lead to further increases in the amplitude of an evoked response;

(ii) acquiring and analyzing late waves, using a stimulation electrode and a detection electrode, under submaximal stimulation conditions;

(iii) modifying the stimulation conditions based on real-time monitoring of the late wave analysis outcomes; and

(iv) extracting and comparing F-wave features under alternative stimulation conditions.

40. Apparatus for acquiring submaximal F-wave features, comprising:

(i) a unit for determining a submaximal stimulation level for submaximal F-wave acquisition, wherein the submaximal stimulation level is an intensity level which is less than a maximal stimulus intensity and less than a near maximal stimulus intensity, wherein the submaximal stimulation level is an intensity level which is approximately fifty percent of a maximal stimulus intensity, and further wherein the maximal stimulus intensity is an intensity level at which additional increases in stimulus intensity do not lead to further increases in the amplitude of an evoked response;

(ii) a unit for acquiring and analyzing late waves under submaximal stimulation conditions;

(iii) a unit for modifying the stimulation conditions based on real-time monitoring of the late wave analysis outcomes; and

(iv) a unit for extracting and comparing F-wave features under alternative stimulation conditions.