System and apparatus for automated quantitative assessment, optimization and logging of the effects of a therapy

• US 9,656,075 B2
• Filed: 09/23/2013
• Issued: 05/23/2017
• Est. Priority Date: 03/23/2009
• Status: Active Grant

• Current Assignee: Flint Hills Scientific, LLC
• Original Assignee: Flint Hills Scientific, LLC
• Inventors: Osorio, Ivan
• Primary Examiner(s): Patel, Natasha
• Application Number:
  US14/034,292
• Publication Number:
  US 20140052213A1
• Time in Patent Office: 1,338 Days
• Field of Search: 607139, 607 45, 600378
• CPC Class Codes: A61B 5/369 Electroencephalography [EEG] devices for psychotechnics A61B5/16
• CPC Class Codes: A61B 5/372 Analysis of electroencephalograms
• CPC Class Codes: A61B 5/4094 Diagnosing or monitoring seizure diseases, e.g. epilepsy
• CPC Class Codes: A61B 5/4848 Monitoring or testing the effects of treatment, e.g. of medication
• CPC Class Codes: A61N 1/0529 Electrodes for brain stimulation
• CPC Class Codes: A61N 1/36064 Epilepsy
• CPC Class Codes: A61N 1/36114 Cardiac control, e.g. by vagal stimulation stimulating the heart A61N1/362
• CPC Class Codes: A61N 1/36139 with automatic adjustment
• CPC Class Codes: A61N 1/36146 specified by the stimulation parameters
• CPC Class Codes: A61N 1/3621 for treating or preventing abnormally high heart rate

Abstract

A method for assessment, optimization and logging of the effects of a therapy for a medical condition, including (a) receiving into a signal processor input signals indicative of the subject'"'"'s brain activity; (b) characterizing the spatio-temporal behavior of the brain activity using the signals; (c) delivering a therapy to a target tissue of the subject; (d) characterizing the spatio-temporal effect of the therapy on the brain activity; (e) in response to the characterizing, optimizing at least one parameter of the therapy if the brain activity has not been satisfactorily modified and/or has been adversely modified by the therapy; (f) characterizing the spatio-temporal effect of the at least one optimized parameter; and (g) logging to memory the at least one optimized parameter. A computer readable program storage unit encoded with instructions that, when executed by a computer, performs the method.

Claims

1. A method for optimizing the effect of a therapy, comprising:

determining a wave rhythmicity of brain activity of a subject, wherein said wave rhythmicity is measured using an autocorrelation function (ACF), and

applying a therapy to a target tissue of said subject at a first time, wherein said target tissue and said first time are based upon said wave rhythmicity.

4. The method of claim 1, wherein determining said wave rhythmicity of brain activity of said subject comprises:

acquiring a first signal relating to a first portion of a brain of a subject; and

determining an amount of waveform stereotypia relating to said first signal.

5. The method of claim 4, further comprising:

acquiring a second signal relating said first portion for determining an effect of said therapy;

modifying at least one parameter of said therapy based upon said effect of said therapy for providing a modified therapy during a second time; and

applying said modified therapy during a second time.

6. The method of claim 5, wherein determining said effect of said therapy comprises determining a spatio-temporal behavior of a response of said therapy.

7. The method of claim 6, wherein determining said spatio-temporal behavior of a response of said therapy comprises determining an electrical oscillations of said target tissue for estimating at least one of:

a power at one or more frequencies;

a waveform or rhythmicity value of said oscillations;

a rate of spread or diffusion the abnormal and therapeutic electrical activity;

an extent of spread and the geometry or shape of the advancing abnormal and therapeutic electrical oscillations;

a change in power at one or more frequencies;

a rate of change in power;

a change in rhythmicity values at one or more frequencies at one more brain sites;

or

a rate of change in rhythmicity values at one or more frequencies.

8. The method of claim 1, wherein said therapy comprises at least one of an electrical therapy, a magnetic therapy, a chemical therapy, a heating therapy, a cooling therapy, a pressure therapy, a vacuum therapy, a cognitive therapy, or a motor therapy.

9. The method of claim 1, wherein said first time is associated with a high probability of blockage of an epileptic event when said therapy is applied.

10. The method of claim 1, wherein said wave rhythmicity relates to brain activity in a first brain region.

2. A method for optimizing the effect of a therapy, comprising:

estimating the level of synchrony within one brain epileptogenic region, wherein said estimating said level of said synchrony comprises determining a level of wave rhythmicity within said brain epileptogenic region, wherein said wave rhythmicity is measured using an autocorrelation function (ACF), and

determining if said level of synchrony is above or below a value associated with a high probability of blockage of an epileptic event when said therapy is applied; and

delivering said therapy to a target tissue of a subject.

3. The method of claim 2, wherein delivery of said therapy is timed to coincide with said synchrony level reaching said value associated with said high probability of blockage of said epileptic event.

11. The method of claim 2, wherein said synchrony is an electrical synchrony.

12. A computer readable program storage unit encoded with instructions that, when executed by a computer, performs a method of optimizing the effects of a therapy, the method comprising:

(a) determining the spatio-temporal behavior of one or more of a patient'"'"'s seizures and said patient'"'"'s response to a therapy in one or more dimensions, at one or more sites, at one or more points in time, at one or more time-scales, and at one or more frequencies, wherein said determining said spatio-temporal behavior comprises determining a level of wave rhythmicity within said brain epileptogenic region, wherein said wave rhythmicity is measured using an autocorrelation function (ACF);

(b) building a probability density function based on said spatio-temporal behavior;

(c) creating a library of seizure features;

(d) cataloging the one or more seizures according to a degree of similarity to at least one of the seizure or therapy response features;

(e) classifying said one or more seizures as known or unknown;

(f) creating a library of treatment and parameter modalities;

(g) classifying said treatment modalities as beneficial or detrimental;

(h) saving at least one feature of said one or more seizures into a library of unmatched events if it does not match a known seizure type;

(i) saving at least one therapy response to a beneficial treatment library if it is beneficial or to a detrimental treatment library if it is detrimental;

(j) optimizing the therapy parameters;

(k) saving the optimized parameters; and

(l) delivery of said therapy comprising the optimized parameters to a target tissue of said patient.

13. The computer readable program storage unit of claim 12, wherein determining said spatio-temporal behavior comprises at least one of estimation of power and its rate of change, estimation of one or more rhythmicity values and their rate of change, or estimation of the extent, rate of spread and shape of spread of abnormal and therapeutic electrical activities.

14. The computer readable program storage unit of claim 12, wherein classifying said one or more seizures comprises estimating an interval of said probability density function into which the values of the one or more seizures fall and classify the seizure as known or unknown based on said interval.

15. The computer readable program storage unit of claim 12, wherein classifying said treatment modalities comprises estimating the interval of the probability density function in which one or more of the seizure or the response therapy fall, and using said estimate to determine the probability with which the seizure matches a known seizure type from said site in said patient and the probability that the therapy response is beneficial or detrimental.