Method and apparatus for the detection of neuromuscular disease using disease specific evoked neuromuscular response analysis

• US 20030093006A1
• Filed: 11/06/2002
• Published: 05/15/2003
• Est. Priority Date: 11/06/2001
• Status: Active Grant

• Current Assignee: Neurometrix, Inc.
• Original Assignee: Neurometrix, Inc.
• Inventors: Gozani, Shai N., Wells, Martin D.
• Granted Patent: US 7,452,335 B2
• Time in Patent Office: Days
• 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 5/388 Nerve conduction study, e.g. detecting action potential of peripheral nerves
• CPC Class Codes: A61B 5/4041 Evaluating nerves condition

Abstract

A method and apparatus for assessing neuromuscular pathology in an individual, by (a) applying a plurality of stimuli to a peripheral nerve; (b) recording from the peripheral nerve, or from a muscle innervated by the peripheral nerve, at least one response to each stimulus; (c) processing each response into at least one response characteristic; (d) compiling the response characteristics from all of the responses into a plurality of descriptive parameters of the response characteristics; and (e) analyzing the plurality of descriptive parameters according to a function specific to the neuromuscular pathology so as to yield an indicator of the pathology.

Claims

1. A method for assessing neuromuscular pathology in an individual, comprising the steps of:

(a) applying a plurality of stimuli to a peripheral nerve;

(b) recording from the peripheral nerve, or from a muscle innervated by the peripheral nerve, at least one response to each said stimulus;

(c) processing each said response into at least one response characteristic;

(d) compiling said response characteristics from all of said responses into a plurality of descriptive parameters of said response characteristics; and

(e) analyzing said plurality of descriptive parameters according to a function specific to the neuromuscular pathology so as to yield an indicator of the pathology.

2. The method of claim 1 wherein the neuromuscular pathology comprises one from the group consisting of upper extremity nerve entrapment syndrome, diabetic neuropathy, nerve compression, nerve transection, nerve root compression, biochemical nerve root dysfunction, systemic nerve disease, ALS, multiple sclerosis, Alzheimer'"'"'s disease, dementia and polyneuropathies.

3. The method of claim 1 wherein the peripheral nerve is at least one branch of a nerve from the group consisting of the median nerve, the ulnar nerve, the peroneal nerve, the tibial nerve, the radial nerve, and the sural nerve.

4. The method of claim 1 wherein said stimuli consist of electrical impulses.

5. The method of claim 1 wherein said response comprises a CMAP generated by a muscle innervated by the stimulated nerve.

6. The method of claim 1 wherein said response comprises an F-wave potential generated by a muscle innervated by the stimulated nerve.

7. The method of claim 6 wherein said at least one response characteristic comprises the presence of an F-wave within said response.

8. The method of claim 6 wherein said at least one response characteristic comprises the F-wave onset latency.

9. The method of claim 6 wherein said at least one response characteristic comprises the F-wave amplitude.

10. The method of claim 6 wherein said at least one response characteristic comprises the duration of the F-wave.

11. The method of claim 1 wherein said response comprises a CMAP generated by the stimulated nerve at a location different from stimulation site.

12. The method of claim 1 wherein said response comprises a sympathetic skin response.

13. The method of claim 1 wherein said descriptive parameter is the mean of said response characteristic.

14. The method of claim 1 wherein said descriptive parameter is a percentile value of said response characteristic.

15. The method of claim 14 wherein said percentile is 0.

16. The method of claim 14 wherein said percentile is 50.

17. The method of claim 14 wherein said percentile is 100.

18. The method of claim 1 wherein said function that is specific to said neuromuscular pathology is a linearly weighted sum of said plurality of descriptive parameters.

19. The method of claim 1 wherein said function that is specific to said neuromuscular pathology is a nonlinear combination of said plurality of descriptive parameters.

20. The method of claim 19 wherein said function is determined by an artificial neural network.

21. The method of claim 1 wherein said indicator is a probability that the neuromuscular pathology is present.

22. The method of claim 1 wherein said indicator is a factor representing the severity of the neuromuscular pathology.

23. The method of claim 1 further comprising an analysis of said indicator to determine whether the neuromuscular pathology is present in the individual.

24. The method of claim 23 wherein said analysis of said indicator comprises comparing said indicator to a threshold value.

25. The method of claim 1 further comprising an analysis of said indicator to determine whether the neuromuscular pathology has progressed in the individual.

26. The method of claim 25 wherein said analysis comprises comparing said indicator to the same said indicator determined at an earlier time.

27. The method of claim 1 wherein said response characteristic is the CMAP distal motor latency.

28. The method of claim 1 wherein said response characteristic is the CMAP amplitude.

29. The method of claim 1 wherein said response comprises an A-wave.

30. The method of claim 1 wherein said response comprises an axon reflex.

31. The method of claim 1 wherein said response comprises a Hoffman reflex.

32. The method of claim 1 wherein said response comprises sensory nerve action potential.

33. The method of claim 1 wherein said descriptive parameter is the persistance of said response characteristic.

34. Apparatus for assessing neuromuscular pathology in an individual, said apparatus comprising:

(a) a stimulator for activating a peripheral nerve;

(b) one or more recording channels for recording evoked responses from the peripheral nerve, or from a muscle innervated by the peripheral nerve; and

(c) a processor for processing the responses into a plurality of response characteristics, compiling said response characteristics into a plurality of descriptive parameters, operating on said descriptive parameters with a function that is specific to the neuromuscular pathology so as to yield a disease indication, and analyzing said disease indication in order to assess the existence or progression of the neuromuscular pathology.

35. The method of claim 34 wherein said stimulator comprises a circuit that delivers electrical stimuli.

36. The method of claim 35 wherein said electrical stimuli comprises discrete pulses of current at a fixed magnitude.

37. A method for the determination of a function whose output indicates neuromuscular pathology in an individual, the method comprising the steps of:

(a) recording, from a peripheral nerve, or from a muscle innervated by a peripheral nerve, a plurality of responses evoked by a plurality of stimuli delivered to the peripheral nerve;

(b) processing each of said responses into at least one response characteristic;

(c) compiling said response characteristics from all of said responses into a plurality of descriptive parameters;

(d) repeating steps (a), (b) and (c) on a plurality of individuals without the neuromuscular pathology to generate a first set of said descriptive parameters;

(e) repeating steps (a), (b) and (c) on a plurality of individuals with the neuromuscular pathology so as to generate a second set of descriptive parameters; and

(f) processing said first set of descriptive parameters and said second set of descriptive parameters so as to determine a function of said descriptive parameters that is indicative of the neuromuscular pathology.

38. The method of claim 37 wherein said processing of said first and second sets of descriptive parameters is performed using logistic regression analysis.

39. The method of claim 37 wherein said processing of said first and second sets of descriptive parameters is performed using an artificial neural network.

40. The method of claim 37 wherein said processing of said first and second sets of descriptive parameters is performed using linear discriminate analysis.

41. The method of claim 37 wherein said processing of said first and second sets of descriptive parameters is performed using linear multivariate regression.

42. The method of claim 37 wherein said processing of said first and second sets of descriptive parameters is performed using clustering.