Quantitative multivariate analysis of seizures

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.

What is claimed: 
     
         1 . A method of assessing an efficacy of an epilepsy therapy via one or more processors of one or more medical devices, the method comprising:
 assessing the efficacy of the epilepsy therapy;   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 the quantifying, selected from reporting the at least one relationship, reporting the efficacy assessment of the epilepsy therapy, assessing an adverse effect of the epilepsy therapy, providing a therapy modification recommendation, or adjusting the epilepsy therapy.   
     
     
         2 . The method of  claim 1 , further comprising ranking at least two of the plurality of the independent variables, at least two of the plurality of the 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 the at least one relationship. 
     
     
         4 . The method of  claim 1 , wherein each of the dependent variables is selected from an intensity of a 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 the adverse effect of the epilepsy therapy. 
     
     
         5 . The method of  claim 4 , wherein at least one of the 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 the plurality of independent variables is selected from whether a seizure was treated with the epilepsy therapy, whether a prior seizure was treated with the epilepsy therapy, a time elapsed since a previous treatment with the epilepsy therapy, a number of seizures since a previous treatment with the epilepsy 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 the epilepsy therapy, a dose of the epilepsy 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, a concentration of medicaments or chemicals in a tissue, or two or more of the foregoing. 
     
     
         7 . The method of  claim 1 , wherein the epilepsy therapy is selected from an electrical stimulation of a target structure of a 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 the quantifying comprises a regression analysis on the plurality of the dependent variables and the plurality of the 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 and a therapy and data relating to a plurality of independent variables, wherein each of the 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 the dependent variables and at least two of the independent variables; and   a responsive action unit configured to perform an action in response to the quantifying, wherein the action is selected from reporting the at least one relationship, assessing an efficacy of the therapy, assessing an adverse effect of the therapy, providing a therapy modification recommendation, or adjusting the therapy.   
     
     
         10 . The medical device system of  claim 9 , wherein the data quantification unit comprises a regression analysis unit configured to perform a regression analysis on the at least two the dependent variables and the at least two the 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 the plurality of dependent variables, and
 wherein the data acquisition unit is configured to acquire at least some dependent variable data based on the 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 the plurality of independent variables, and
 wherein the data acquisition unit is configured to acquire at least some independent variable data based on the 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 the patient. 
     
     
         14 . The medical device system of  claim 13 , wherein the therapy unit is configured to: administer an electrical stimulation to a target structure of a brain, a target portion of a cranial nerve, or both of the patient; a drug to a body of a patient; a thermal therapy to a target structure of the brain, a target portion of the cranial nerve, or both of the patient; a sensory therapy to a sensory organ of the patient; or a cognitive therapy to the patient. 
     
     
         15 . A method implemented via one or more processors of one or more medical devices, the 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 a patient;   modeling a relationship between the plurality of the independent variables and the plurality of the dependent variables using a model;   ranking at least two independent variables based upon the modeling, wherein the ranking according to at least one of a magnitude and a direction of the relationship; and   initiating one or more therapeutic actions based on the ranking.   
     
     
         16 . The method of  claim 15 , further comprising performing a model adjustment process based upon the modeling, wherein the model adjustment process comprises determining whether the model has a predetermined goodness of fit, and adjusting the model is based at least in part on a finding that the model lacks the goodness of fit. 
     
     
         17 . The method of  claim 16 , wherein adjusting the model comprises adding or removing at least one independent variable from the plurality of independent variables. 
     
     
         18 . The method of  claim 16 , further comprising assessing an efficacy of the model. 
     
     
         19 . The method of  claim 16 , further comprising assessing an efficacy of the one or more therapeutic actions. 
     
     
         20 . The method of  claim 19 , further comprising modifying the one or more therapeutic actions based on the efficacy assessment of the one or more therapeutic actions.