QUANTITATIVE MULTIVARIATE ANALYSIS OF SEIZURES

• US 20110295332A1
• Filed: 05/26/2011
• Published: 12/01/2011
• Est. Priority Date: 05/26/2010
• Status: Active Grant

• Current Assignee: Flint Hills Scientific, LLC
• Original Assignee: Flint Hills Scientific, LLC
• Inventors: Osorio, Ivan
• Granted Patent: US 10,321,841 B2
• Time in Patent Office: Days
• US Class Current: 607/3
• CPC Class Codes: A61B 5/369 Electroencephalography [EEG] devices for psychotechnics A61B5/16
• CPC Class Codes: A61B 5/4094 Diagnosing or monitoring seizure diseases, e.g. epilepsy
• CPC Class Codes: A61B 5/4833 Assessment of subject's compliance to treatment
• CPC Class Codes: A61N 1/36064 Epilepsy
• CPC Class Codes: A61N 1/36139 with automatic adjustment
• CPC Class Codes: G16H 50/20 for computer-aided diagnosis, e.g. based on medical expert systems

Abstract

Methods, including a method, comprising selecting a plurality of dependent variables relating to each of a plurality of seizures in a patient; selecting a plurality of independent variables, wherein each independent variable comprises a therapy parameter, a therapy delivery parameter, a temporal factor, an environmental factor, or a patient factor; quantifying at least one relationship between each of at least two dependent variables and each of at least two independent variables; and performing an action in response to said quantifying, selected from reporting said at least one relationship, assessing an efficacy of a therapy, assessing an adverse effect of said therapy, providing a therapy modification recommendation, or adjusting said therapy. A medical device system capable of implementing a method. A non-transitory computer readable program storage medium containing instructions that, when executed by a computer, perform a method.

Claims

1. A method of assessing an efficacy of an epilepsy therapy, comprising:

selecting a plurality of dependent variables relating to each of a plurality of seizures in a patient;

selecting a plurality of independent variables, wherein each independent variable comprises a therapy parameter, a therapy delivery parameter, a temporal factor, an environmental factor, or a patient factor;

quantifying at least one relationship between each of at least two dependent variables and each of at least two independent variables; and

performing an action in response to said quantifying, selected from reporting said at least one relationship, assessing an efficacy of a therapy, assessing an adverse effect of said therapy, providing a therapy modification recommendation, or adjusting said therapy.

2. The method of claim 1, further comprising ranking at least two of said plurality of said independent variables, at least two of said plurality of said dependent variables, or both, according to at least one of a magnitude or a direction.

3. The method of claim 1, further comprising logging to memory data relating to said at least one relationship.

4. The method of claim 1, wherein each of said dependent variables is selected from an intensity of the seizure, a duration of the seizure, an extent of spread of the seizure, a seizure severity index, a seizure frequency, an inter-seizure interval(s), or an adverse effect of a therapy.

5. The method of claim 4, wherein at least one of said plurality of dependent variables is the seizure severity index, wherein the seizure severity index comprises one or more of an autonomic index, a neurologic index, a metabolic index, a respiratory index, a tissue stress marker, a musculoskeletal index, or an endocrine index.

6. The method of claim 1, wherein each of said plurality of independent variables is selected from whether the seizure was treated with a therapy, whether a prior seizure was treated with a therapy, a time elapsed since a previous treatment with a therapy, a number of seizures since a previous treatment with a therapy, a time of day the seizure occurred, a time of month the seizure occurred, a time of year the seizure occurred, a type of a therapy, a dose of a therapy, a current density, a degree of tissue cooling, a degree of tissue warming, a level of consciousness, a level and type of cognitive activity, a level and type of physical activity, a state of health, the concentration of medicaments or chemicals in a tissue, or two or more of the foregoing.

7. The method of claim 1, wherein said at least one therapy is selected from an electrical stimulation of a target structure of the brain, an electrical stimulation of a cranial nerve, a drug, a thermal treatment of a neural structure, a cognitive therapy, or two or more thereof.

8. The method of claim 1, wherein said quantifying comprises a regression analysis on said plurality of said dependent variables and said plurality of said independent variables.

9. A medical device system, comprising:

a data acquisition unit configured to acquire data relating to a plurality of dependent variables relating to each of a plurality of seizures in a patient and data relating to a plurality of independent variables, wherein each of said independent variables comprises a therapy parameter, a therapy delivery parameter, a temporal factor, an environmental factor, or a patient factor;

a data quantification unit configured to quantify at least one relationship between at least two of said dependent variables and at least two of said independent variables; and

a responsive action unit configured to perform an action in response to said quantifying, wherein said action is selected from reporting said at least one relationship, assessing an efficacy of a therapy, assessing an adverse effect of said therapy, providing a therapy modification recommendation, or adjusting said therapy.

10. The medical device system of claim 9, wherein said data quantification unit comprises a regression analysis unit configured to perform a regression analysis on said at least two said dependent variables and said at least two said independent variables.

11. The medical device system of claim 9, further comprising at least one sensor configured to sense at least one body signal relating to at least one of said plurality of dependent variables, and

wherein said data acquisition unit is configured to acquire at least some dependent variable data based on said at least one body signal.

12. The medical device system of claim 9, further comprising at least one sensor configured to sense at least one signal relating to at least one of said plurality of independent variables, and

wherein said data acquisition unit is configured to acquire at least some independent variable data based on said at least one signal.

13. The medical device system of claim 9, further comprising a therapy unit configured to administer at least one therapy to said patient.

14. The medical device system of claim 13, wherein said therapy unit is configured to administer an electrical stimulation to a target structure of the brain, a target portion of a cranial nerve, or both of said patient;

a drug to the body of said patient;

a thermal therapy to a target structure of the brain, a target portion of a cranial nerve, or both of said patient;

a sensory therapy to a sensory organ of said patient;

or a cognitive therapy to said patient.

15. The medical device system of claim 9, further comprising an efficacy assessment unit configured to assess an efficacy of at least one therapy.

16. A non-transitory computer readable program storage medium containing instructions that, when executed by a computer, perform a method of assessing an efficacy of an epilepsy therapy, comprising:

selecting a plurality of dependent variables relating to each of a plurality of seizures in a patient;

selecting a plurality of independent variables, wherein each independent variable comprises a therapy parameter, a therapy delivery parameter, a temporal factor, an environmental factor, or a patient factor;

quantifying at least one relationship between each of at least two dependent variables and each of at least two independent variables; and

performing an action in response to said quantifying, selected from reporting said at least one relationship, assessing an efficacy of a therapy, assessing an adverse effect of said therapy, providing a therapy modification recommendation, or adjusting said therapy.

17. The non-transitory computer readable program storage medium of claim 16, wherein said method further comprises ranking at least two of said plurality of said independent variables, at least two of said plurality of said dependent variables, or both, according to at least one of a magnitude or a direction.

18. The non-transitory computer readable program storage medium of claim 16, wherein each of said dependent variables is selected from an intensity of the seizure, a duration of the seizure, an extent of spread of the seizure, a seizure severity index, a seizure frequency, an inter-seizure interval(s), or an adverse effect of a therapy.

19. The non-transitory computer readable program storage medium of claim 18, wherein the seizure severity index comprises one or more of an autonomic index, a neurologic index, a metabolic index, a respiratory index, a tissue stress marker, a musculoskeletal index, or an endocrine index.

20. The non-transitory computer readable program storage medium of claim 16, wherein each of said plurality of independent variables is selected from whether the seizure was treated with a therapy, whether a prior seizure was treated with a therapy, a time elapsed since a previous treatment with a therapy, a number of seizures since a previous treatment with a therapy, a time of day the seizure occurred, a time of month the seizure occurred, a time of year the seizure occurred, a type of a therapy, a dose of a therapy, a current density, a degree of tissue cooling, a degree of tissue warming, a level of consciousness, a level and type of cognitive activity, a level an type of physical activity, a state of health, a concentration of medicaments or chemicals in a tissue, or two or more of the foregoing.

21. The non-transitory computer readable program storage medium of claim 16, wherein said at least one therapy is selected from an electrical stimulation of a target structure of the brain, an electrical stimulation of a target portion of a cranial nerve, a drug, a thermal treatment of a target portion of a neural structure, a cognitive therapy, or two or more thereof.

22. The non-transitory computer readable program storage medium of claim 16, wherein said quantifying comprises a regression analysis on said at least two of said dependent variables and said at least two of said independent variables.

23. A method, comprising:

receiving data relating to a plurality of independent variables selected from therapy parameters, patient parameters, or temporal parameters;

receiving data relating to a plurality of dependent variables resulting from each of a plurality of epileptic events undergone by said patient;

modeling a relationship between said plurality of said independent variables and said plurality of said dependent variables using a model; and

ranking at least two independent variables based upon said modeling, wherein the ranking according to at least one of a magnitude and a direction of said relationship.

24. A non-transitory computer readable program storage medium containing instructions that, when executed by a computer, perform a method, comprising:

receiving data relating to a plurality of independent variables selected from therapy parameters, patient parameters, or temporal parameters;

receiving data relating to a plurality of dependent variables resulting from each of a plurality of epileptic events undergone by said patient;

modeling a relationship between at least two of said plurality of said independent variables and said plurality of said dependent variables using a model; and

performing a model adjustment process based upon said modeling, wherein the model adjustment process comprises determining whether said model has a predetermined goodness of fit, and adjusting said model is based at least in part on a finding that said model lacks said goodness of fit.

25. The method of claim 24, wherein adjusting said model comprises adding or removing at least one independent variable from said plurality of independent variables.