Methods and systems for recommending an appropriate pharmacological treatment to a patient for managing epilepsy and other neurological disorders

• US 20070150025A1
• Filed: 12/28/2005
• Published: 06/28/2007
• Est. Priority Date: 12/28/2005
• Status: Active Grant

• Current Assignee: DiLorenzo Biomedical, LLC
• Original Assignee: Cyberonics, Inc
• Inventors: Leyde, Kent, Dilorenzo, Daniel
• Granted Patent: US 8,725,243 B2
• Time in Patent Office: Days
• US Class Current: 607/45
• CPC Class Codes: A61B 5/024 Detecting, measuring or recording pulse rate or heart rate A61B5/0205, A61B5/021 take precedence
• CPC Class Codes: A61B 5/369 Electroencephalography [EEG] devices for psychotechnics A61B5/16
• CPC Class Codes: A61B 5/37 Intracranial electroencephalography [IC-EEG], e.g. electrocorticography [ECoG]
• 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: A61B 5/7264 Classification of physiological signals or data, e.g. using neural networks, statistical classifiers, expert systems or fuzzy systems neural networks per se G06N3/00; expert systems per se G06N5/00
• CPC Class Codes: A61B 5/7275 Determining trends in physiological measurement data; Predicting development of a medical condition based on physiological measurements, e.g. determining a risk factor
• CPC Class Codes: A61M 5/1723 using feedback of body parameters, e.g. blood-sugar, pressure measurement of body parameters A61B5/00
• CPC Class Codes: A61N 1/36064 Epilepsy
• CPC Class Codes: A61N 1/36082 Cognitive or psychiatric applications, e.g. dementia or Alzheimer's disease
• CPC Class Codes: A61N 1/37258 Alerting the patient
• CPC Class Codes: G16H 20/10 relating to drugs or medications, e.g. for ensuring correct administration to patients
• CPC Class Codes: G16H 20/30 relating to physical therapies or activities, e.g. physiotherapy, acupressure or exercising
• CPC Class Codes: G16H 50/20 for computer-aided diagnosis, e.g. based on medical expert systems
• CPC Class Codes: G16H 50/30 for calculating health indices; for individual health risk assessment

Abstract

The present invention provides systems and methods for managing epilepsy. In one embodiment, a method of the present invention characterize a patient'"'"'s propensity for a future epileptic seizure and communicates to the patient and/or a health care provider a therapy recommendation. The therapy recommendation is typically a function of the patient'"'"'s propensity for the future epileptic seizure.

Claims

1. A method of preventing an epileptic seizure comprising:

characterizing a patient'"'"'s propensity for an onset of a future epileptic seizure; and

communicating to the patient and/or a health care provider a therapy recommendation,

wherein parameters of the therapy recommendation are a function of the patient'"'"'s propensity for the onset of the epileptic seizure.

2. The method of claim 1 wherein the characterizing the patient'"'"'s propensity for the epileptic seizure is performed by characterizing a neural state of a patient

3. The method of claim 2 wherein characterizing the neural state of the patient comprises measuring one or more patient dependent parameters.

4. The method of claim 3 wherein the patient dependent parameters comprise EEG signals.

5. The method of claim 4 wherein the measured EEG signals are measured using an intracranial electrode array.

6. The method of claim 1 wherein the therapy recommendation comprises an instruction to administer an acute dosage of an anti-epileptic agent.

7. The method of claim 6 wherein the therapy recommendation comprises dosage information for the anti-epileptic agent, wherein the dosage is selected based on the patient'"'"'s characterized propensity for the onset of the future epileptic seizure.

8. The method of claim 7 wherein the patient'"'"'s characterized propensity for the onset of the future epileptic seizure is indicative of a seizure onset time parameter, the dosage information comprising a dose inversely related to the time parameter.

9. The method of claim 7 wherein the patient'"'"'s characterized propensity for the onset of the future epileptic seizure is indicative of a probability parameter, the dosage information comprising a dose directly related to the probability parameter.

10. The method of claim 7 wherein the dosage information is a dose lower than an FDA-approved dose for the anti-epileptic agent.

11. The method of claim 7 wherein the dosage information is a dose higher than an FDA-approved dose for the anti-epileptic agent.

12. The method of claim 7 wherein the dosage information is a dose equivalent to an FDA-approved dose for the anti-epileptic agent.

13. The method of claim 6 wherein the therapy recommendation specifies a form of the anti-epileptic agent, a formulation of the anti-epileptic agent, and/or a route of administration of the anti-epileptic agent.

14. The method of claim 1 wherein the therapy recommendation comprises electrical stimulation of a vagus nerve.

15. A method of managing an epileptic seizure comprising:

characterizing a neural state of a patient;

characterizing a patient'"'"'s propensity for an epileptic seizure based on the neural state; and

facilitating administration of a pharmacological therapy to the patient, the pharmacological therapy being a function of the patient'"'"'s propensity for the epileptic seizure.

16. The method of claim 15 wherein facilitating administration comprises recommending an administration of an acute dose of a pharmacological agent prior to the epileptic seizure.

17. The method of claim 16 wherein the anti-epileptic agent modulates a neuronal calcium channel, a neuronal potassium channel, a neuronal GABA channels, a neuronal NMDA channel, a neuronal AMPA channel, a neuronal metabotropic type channel, a neuronal sodium channel, and/or a neuronal kainite channel.

18. The method of claim 15 wherein the pharmacological therapy comprises automatic administration of an anti-epileptic agent to the patient.

19. The method of claim 18 wherein the anti-epileptic agent is administered with a medication dispenser implanted within the patient'"'"'s body.

20. The method as in claim 15 wherein the neural state is characterized by analyzing signals from the patient'"'"'s brain.

21. The method of claim 20 wherein the signals from the patient'"'"'s brain comprise at least one of EEG, brain temperature, chemical concentrations in the brain, pH in the brain, and blood flow in the brain.

22. The method as in claim 15 wherein facilitating administration is configured to maintain the neural state within a desired range.

23. The method as in claim 15 wherein facilitating administration is configured to prevent the neural state from progressing outside a desired range.

24. The method as in claim 15 wherein facilitating administration is configured to prevent the neural state from entering an undesirable range.

25. The method of claim 15 further comprising administering an electrical stimulation.

26. The method of claim 25 wherein the electrical stimulation comprises electrical stimulation of a vagus nerve.

28. A method of preventing a predicted epileptic seizure comprising:

administering an effective amount of an anti-epileptic drug to a patient in need thereof;

the administration being at a time prior to a predicted occurrence of a seizure and the time being at least 30 seconds,

the effective amount being less than about 50% of a dose of the drug that is effective after a seizure has occurred and the effective amount being a function of the time prior to the predicted occurrence of the seizure.

29. The method of claim 28 wherein the time is between about 30 seconds and about 30 minutes

30. The method of claim 28 wherein the anti-epileptic drug is midazolam.

31. The method of claim 30 wherein the midazolam is administered in a buccal, intranasal, or intramuscular formulation.

32. The method of claim 28 wherein the anti-epileptic drug is diazepam.

34. The method of claim 28 wherein the anti-epileptic drug is lorazepam.

35. The method of claim 34 wherein the lorazepam is administered in an intravenous formulation.

36. The method of claim 28 wherein the effective amount is less than about 25% of the drug that is effective after the seizure has occurred.

37. The method of claim 28 wherein the effective amount is less than about 10% of the drug that is effective after the seizure has occurred.

38. The method of claim 28 wherein the effective amount is less than about 5% of the drug that is effective after the seizure has occurred.

39. The method of claim 28 wherein the anti-epileptic drug comprises a benzodiazepine.

33. The method of claim 33 wherein the diazepam is administered in a rectal or intravenous formulation.