Analyzing a washout period characteristic for psychiatric disorder therapy delivery

• US 9,613,184 B2
• Filed: 04/17/2009
• Issued: 04/04/2017
• Est. Priority Date: 04/18/2008
• Status: Expired due to Fees

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Giftakis, Jonathon E., Rise, Mark T., Stypulkowski, Paul H., Denison, Timothy J.
• Primary Examiner(s): Levicky, William
• Assistant Examiner(s): Hankins, Lindsey G
• Application Number:
  US12/426,065
• Publication Number:
  US 20090264957A1
• Time in Patent Office: 2,909 Days
• Field of Search: 607 1, 607 2, 607 45
• CPC Class Codes: A61M 2005/14208 with a programmable infusion control system, characterised by the infusion program
• CPC Class Codes: A61M 2205/3561 local, e.g. within room or hospital
• CPC Class Codes: A61M 2205/3592 using telemetric means, e.g. radio or optical transmission
• CPC Class Codes: A61M 2210/0693 Brain, cerebrum
• CPC Class Codes: A61M 5/14276 specially adapted for implantation
• 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 1/36025 for treating a mental or cerebral condition
• CPC Class Codes: A61N 1/36082 Cognitive or psychiatric applications, e.g. dementia or Alzheimer's disease
• CPC Class Codes: A61N 1/37211 Means for communicating with stimulators
• CPC Class Codes: G16H 40/40 for the management of medical equipment or devices, e.g. scheduling maintenance or upgrades
• CPC Class Codes: G16H 40/63 for local operation
• CPC Class Codes: G16Z 99/00 Subject matter not provided for in other main groups of this subclass

Abstract

A characteristic of a washout period following the delivery of therapy to a patient according to a therapy program may be determined based on a physiological parameter of the patient. A washout period includes the period of time during which a carryover effect from the therapy dissipates. The washout period characteristic may include, for example, a duration of the washout period, an amplitude or a trend in a physiological signal during the washout period or a power level or a ratio of power levels in frequency bands of the physiological signal. In some embodiments, washout period characteristics associated with a plurality of therapy programs may be used to compare the programs. In other embodiments, a washout period characteristic may be used to determine a mood state of the patient and, in some cases, modify a therapy program. Monitoring a washout period may also be useful for timing therapy program trials.

Claims

1. A method comprising:

with a medical device, delivering therapy to a patient according to a therapy program during a first period, wherein the therapy program defines a value for at least one therapy parameter for managing a psychiatric condition of the patient;

monitoring a physiological signal of the patient during a second period immediately following the first period;

automatically determining a characteristic of a washout period based on the monitored physiological signal, wherein the washout period occurs during the second period, and wherein at least one carryover effect from the therapy substantially dissipates during the washout period;

determining a patient mood state or a mood state probability based on the characteristic of the washout period;

detecting a change in the physiological signal from a baseline state of the physiological signal during the second period; and

determining when the physiological signal returns to the baseline state during the second period, wherein a time period for the physiological signal to return to the baseline state during the second period defines the washout period.

2. The method of claim 1, further comprising determining a baseline value of the physiological signal prior to delivery of therapy according to the therapy program, wherein determining when the physiological signal returns to the baseline state during the second period comprises determining when the physiological signal returns to the baseline value or within a predefined percentage of the baseline value.

3. The method of claim 2, wherein detecting the change in the physiological signal from the baseline state comprises at least one of comparing a peak amplitude of the physiological signal to a threshold amplitude, comparing an average amplitude of the physiological signal to the threshold amplitude, comparing a median amplitude of the physiological signal to the threshold amplitude, comparing a trend in a waveform of the physiological signal over time to a template, comparing a power level within one or more frequency bands of the physiological signal to a threshold power level or comparing a ratio of power levels in two or more frequency bands of the physiological signal to a threshold power level ratio, and detecting the change in the physiological signal from the baseline state based on the comparison.

4. A method comprising:

with a medical device, delivering therapy to a patient according to a therapy program during a first period, wherein the therapy program defines a value for at least one therapy parameter for managing a psychiatric condition of the patient;

monitoring a physiological signal of the patient during a second period immediately following the first period;

automatically determining a characteristic of a washout period based on the monitored physiological signal, wherein the washout period occurs during the second period, and wherein at least one carryover effect from the therapy substantially dissipates during the washout period; and

determining a patient mood state or a mood state probability based on the characteristic of the washout period,

wherein determining a patient mood state or a mood state probability based on the characteristic of the washout period comprises determining the patient mood state based on the characteristic of the washout period by at least comparing the characteristic to a threshold value or comparing the characteristic to a trend template and determining the patient mood state based on the comparison, wherein the threshold value and trend templates are associated with the patient mood state.

5. The method of claim 4, wherein the characteristic of the washout period comprises a duration of the washout period, an amplitude of the physiological signal during the washout period, a trend in the physiological signal during the washout period, a power level in a frequency band of the physiological signal during the washout period or a ratio of power levels in two or more frequency bands of the physiological signal during the washout period.

6. The method of claim 4, wherein delivering the therapy to the patient comprises delivering electrical stimulation to a target tissue site within a brain of the patient.

7. The method of claim 4, wherein monitoring a physiological signal of the patient comprises monitoring at least one of a brain signal, a heart rate, a respiratory rate, electrodermal activity, facial electromyogram or thermal activity of the patient.

8. The method of claim 4, wherein the physiological signal is indicative of a patient mood state.

9. The method of claim 4, wherein delivering therapy to the patient comprises delivering therapy to the patient according to a plurality of therapy programs, monitoring the physiological signal of the patient comprises monitoring the physiological signal during the time period after the delivery of therapy according to each of the therapy programs, and automatically determining the characteristic of the washout period comprises automatically determining the characteristic of the washout period for each therapy program based on a respective monitored physiological signal, the method further comprising ordering the plurality of therapy programs based on the characteristics of the respective washout periods.

10. The method of claim 9, wherein, for each of the therapy programs, the characteristic of the washout period comprises a first metric, the method further comprising, for each of the therapy programs:

determining a second metric comprising at least one of an efficacy rating, a mood indicator, an anxiety indicator, a patient energy level, a mood improvement rating, side effects rating, a characteristic of the physiological signal during the first period, or a power usage rating; and

determining a composite metric including the first metric and the second metric.

11. The method of claim 10, wherein determining the composite metric comprises assigning weights to the first and second metrics.

12. The method of claim 10, wherein ordering the plurality of therapy programs based on the characteristics of the respective washout periods comprises ordering the plurality of therapy programs based on the composite metrics.

13. The method of claim 4, further comprising modifying the therapy parameter value based on the characteristic of the washout period.

14. The method of claim 4, wherein determining the patient mood state or the mood state probability comprises determining the mood state or the mood state probability associated with the characteristic in a memory of a device.

15. A method comprising:

delivering therapy to a patient according to a therapy program during a first period;

monitoring a physiological signal of the patient during a second period following the first period;

receiving information indicative of a patient mood state, wherein the patient mood state occurs during the first or second period;

associating the patient mood state with at least one characteristic of the physiological signal during the second period;

detecting a change in the physiological signal from a baseline state of the physiological signal during the second period; and

determining when the physiological signal returns to the baseline state during the second period, wherein the at least one characteristic of the physiological signal comprises a time period for the physiological signal to return to the baseline state during the second period.

16. The method of claim 15, wherein the at least one characteristic of the physiological signal comprises at least one of an amplitude of the physiological signal during the second period, a trend in the physiological signal during the second period, a power level in a frequency band of the physiological signal or a ratio of power levels in two or more frequency bands of the physiological signal during the second period.

17. The method of claim 15, further comprising associating the characteristic of the physiological signal with a mood state probability based on the information indicative of the patient mood state.

18. A system comprising:

a sensor configured to generate a signal as a function of at least one physiological parameter of a patient;

a medical device configured to deliver therapy to a patient according to a therapy program to manage a psychiatric condition during a first period, wherein the therapy program defines a value for at least one therapy parameter; and

a processor configured to monitor the signal during a second period immediately following the first period, automatically determine a characteristic of a washout period based on the signal, and determine a mood state or mood state probability based on the characteristic of the washout period, wherein the washout period occurs during the second period, and wherein at least one carryover effect from the therapy substantially dissipates during the washout period,

wherein the processor is configured to detect a change in the physiological signal from a baseline state of the physiological signal during the second period, and determine when the physiological signal returns to the baseline state during the second period, wherein a time period for the physiological signal to return to the baseline state during the second period defines the washout period.

19. The system of claim 18, wherein the processor is configured to determine a baseline value of the physiological signal prior to delivery of therapy by the medical device to the patient according to the therapy program, wherein the processor is configured to determine when the physiological signal returns to the baseline state during the second period by at least determining when the physiological signal returns to the baseline value or within a predefined percentage of the baseline value.

20. A system comprising:

a sensor configured to generate a signal as a function of at least one physiological parameter of a patient;

a medical device configured to deliver therapy to a patient according to a therapy program to manage a psychiatric condition during a first period, wherein the therapy program defines a value for at least one therapy parameter; and

a processor configured to monitor the signal during a second period immediately following the first period, automatically determine a characteristic of a washout period based on the signal, and determine a mood state or mood state probability based on the characteristic of the washout period, wherein the washout period occurs during the second period, and wherein at least one carryover effect from the therapy substantially dissipates during the washout period

wherein the processor is configured to determine the patient mood state by at least comparing the characteristic to a threshold value or comparing the characteristic to a trend template and determining the patient mood state based on the comparison, wherein the threshold value and trend templates are associated with the patient mood state.

21. The system of claim 20, further comprising a medical device programmer, wherein the programmer comprises the processor.

22. The system of claim 20, wherein the medical device comprises the processor.

23. The system of claim 20, wherein the physiological parameter comprises at least one of brain activity, a heart rate, respiratory rate, electrodermal activity, facial electromyogram or thermal activity of the patient.

24. The system of claim 20, wherein the sensor comprises a portion external to the patient.

25. The system of claim 20, wherein the sensor comprises a portion implanted within the patient.

26. The system of claim 20, wherein the characteristic of the washout period comprises a duration of the washout period, an amplitude of the physiological signal during the washout period, a trend in the physiological signal during the washout period, a power level in a frequency band of the physiological signal during the washout period or a ratio of power levels in two or more frequency bands of the physiological signal during the washout period.

27. The system of claim 20, wherein the medical device is configured to deliver therapy to the patient according to a plurality of therapy programs, and for each of the therapy programs, the processor is configured to monitor the physiological parameter of the patient during the second period and automatically determine the characteristic of the washout period, wherein the processor is further configured to order the plurality of therapy programs based on the characteristics of the respective washout periods.

28. The system of claim 27, wherein, for each of the plurality of therapy programs, the characteristic of the washout period comprises a first metric, and the system further comprises a user input mechanism, wherein, for each of the therapy programs, the processor is configured to receive a second metric comprising at least one of an efficacy rating via the user input mechanism, a mood indicator via the user input mechanism, an anxiety indicator via the user input mechanism, a patient energy level via the user input mechanism, a mood improvement rating via the user input mechanism, a side effects rating via the user input mechanism, or a power usage rating and determine a composite metric including the first and second metrics.

29. The system of claim 28, wherein the processor is configured to receive, via the user input mechanism, user input selecting at least one of the first, second or composite metrics, and order the plurality of therapy programs based on selected metric.

30. The system of claim 28, wherein the processor is configured to determine the composite metric by at least assigning weights to the first and second metrics.

31. The system of claim 20, wherein the processor is configured to determine a patient mood state based on the characteristic of the washout period.

32. The system of claim 20, wherein the processor is configured to receive information indicative of a patient mood state and associate the patient mood state with the characteristic of the washout period.

33. The system of claim 20, wherein the medical device is configured to deliver at least one of electrical stimulation or a therapeutic agent to the patient.

34. The system of claim 20, further comprising a memory that associates a plurality of mood state characteristics with respective mood states or mood state probabilities, wherein the processor is configured to determine the patient mood state or the mood state probability by at least determining the mood state or the mood state probability associated with the characteristic in the memory.

35. The system of claim 20, wherein the processor is configured to modify the value of the therapy parameter based on the characteristic of the washout period.

36. The system of claim 20, further comprising a memory, wherein the medical device is configured to deliver therapy to the patient according to a plurality of therapy programs, and for each of the therapy programs, the processor is configured to monitor the physiological parameter of the patient during the second period, automatically determine the characteristic of the washout period, and automatically determine the patient mood state based on the characteristic of the washout period, wherein the processor is further configured to, for each therapy program of the plurality of therapy programs, receive input indicating a second mood state experienced by the patient in response to the delivery of the therapy according to the respective therapy program, generate a consistency determination based on whether the first and second mood states are consistent, and associate the consistency determination with the therapy program in the memory, and wherein the processor is further configured to order the plurality of therapy programs based on the consistency determinations associated with each therapy program.

37. A system comprising:

a sensor configured to generate a signal as a function of at least one physiological parameter of a patient;

a medical device configured to deliver therapy to a patient according to a therapy program to manage a psychiatric condition during a first period, wherein the therapy program defines a value for at least one therapy parameter;

a processor configured to monitor the signal during a second period immediately following the first period, automatically determine a characteristic of a washout period based on the signal, and determine a first mood state based on the characteristic of the washout period, wherein the washout period occurs during the second period, and wherein at least one carryover effect from the therapy substantially dissipates during the washout period; and

a memory, wherein the processor is configured to receive input indicating a second mood state experienced by the patient in response to the delivery of the therapy according to the therapy program, generate a consistency determination based on whether the first and second mood states are consistent, and associate the consistency determination with the therapy program in the memory.

38. The system of claim 37, wherein the consistency determination comprises an indication that the first and second mood states are not consistent.

39. The system of claim 37, wherein the consistency determination comprises an indication that the first and second mood states are consistent.

40. The system of claim 37, wherein the input comprises input from a patient identifying the second mood state.

41. The system of claim 37, wherein the therapy program comprises a first therapy program and the consistency determination comprises a first consistency determination, wherein the medical device is configured to deliver the therapy to the patient according to the therapy program during a third period, determine a third patient mood state based on the physiological parameter, receive input indicating a fourth mood state experienced by the patient in response to the delivery of the therapy according to the therapy program during the third period, generate a second consistency determination based on whether the third and fourth mood states are consistent, and associate the second consistency determination with the therapy program in the memory.

42. The method of claim 41, further comprising determining a match percentage based on the first and second consistency determinations.