Treatment of conditions through modulation of the autonomic nervous system during at least one predetermined menstrual cycle phase

• US 7,899,527 B2
• Filed: 05/13/2004
• Issued: 03/01/2011
• Est. Priority Date: 05/13/2004
• Status: Active Grant

• Current Assignee: Palo Alto Investors
• Original Assignee: Palo Alto Investors
• Inventors: Lee, Patrick Yuarn-Bor, Yun, Anthony Joonkyoo
• Primary Examiner(s): Bunner; Bridget E
• Assistant Examiner(s): BORGEEST, CHRISTINA M
• Application Number:
  US10/846,486
• Publication Number:
  US 20050256028A1
• Time in Patent Office: 2,483 Days
• Field of Search: None
• US Class Current: 607/2
• CPC Class Codes: A61K 31/137 Arylalkylamines, e.g. amphetamine, epinephrine, salbutamol, ephedrine or methadone
• CPC Class Codes: A61K 31/4745 condensed with ring systems having nitrogen as a ring hetero atom, e.g. phenantrolines yohimbine derivatives, vinblastine A61K31/475; ergoline derivatives A61K31/48
• CPC Class Codes: A61K 31/57 substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone
• CPC Class Codes: A61K 38/085 Angiotensins
• CPC Class Codes: A61K 38/095 Oxytocins; Vasopressins; Related peptides
• CPC Class Codes: A61K 38/2221 Relaxins
• CPC Class Codes: A61K 38/26 Glucagons
• CPC Class Codes: A61K 38/4813 Exopeptidases (3.4.11. to 3.4.19)
• CPC Class Codes: A61P 15/00 Drugs for genital or sexual disorders for disorders of sex hormones A61P5/24; Contraceptives
• CPC Class Codes: A61P 15/18 Feminine contraceptives
• CPC Class Codes: A61P 25/00 Drugs for disorders of the nervous system
• CPC Class Codes: A61P 31/04 Antibacterial agents
• CPC Class Codes: A61P 5/24 of the sex hormones
• CPC Class Codes: A61P 9/00 Drugs for disorders of the cardiovascular system

Abstract

Methods are provided for treating a subject for a condition. In accordance with the subject methods, at least a portion of a subject'"'"'s autonomic nervous system is modulated during at least one predetermined phase of the subject'"'"'s menstrual cycle to alter the parasympathetic activity/sympathetic activity ratio in a manner that is effective to treat the subject for the condition. The subject methods find use in the treatment of a variety of different conditions, including various disease conditions, that increase in severity and/or occurrence during one or more phases of the menstrual cycle. Also provided are systems and kits for use in practicing the subject methods.

Claims

1. A method of treating a female subject for a menopausal mood disorder or premenstrual mood disorder, said method comprising:

modulating at least a portion of the autonomic nervous system of said subject during the luteal phase of the subject'"'"'s menstrual cycle to increase the parasympathetic activity/sympathetic activity ratio in a manner effective to treat said subject for said menopausal mood disorder or premenstrual mood disorder, wherein said modulating comprises (a) applying electrical energy during the luteal phase of the subject'"'"'s menstrual cycle to said at least one portion of said autonomic nervous system by transcutaneous electrical nerve stimulation (“

TENS”

) or (b) administering an effective amount of at least one beta blocker to said subject during the luteal phase of the subject'"'"'s menstrual cycle;

so that said subject is treated for said menopausal mood disorder or premenstrual mood disorder, wherein said menopausal mood disorder or premenstrual mood disorder is caused by an abnormal decrease in said parasympathetic activity/sympathetic activity ratio during said luteal phase,

and wherein said method further comprises determining said parasympathetic activity/sympathetic activity ratio at least one time during said luteal phase of said menstrual cycle.

2. The method of claim 1, wherein said method comprises increasing parasympathetic activity.

3. The method of claim 1, wherein said method comprises decreasing sympathetic activity.

4. The method of claim 1, wherein said method comprises increasing parasympathetic activity and decreasing sympathetic activity.

5. The method of claim 1, wherein said modulating comprises applying electrical energy to said at least one portion of said autonomic nervous system.

6. The method of claim 5, wherein said application of electrical energy comprises electrically increasing activity in at least one portion of the parasympathetic nervous system.

7. The method of claim 5, wherein said application of electrical energy comprises electrically inhibiting activity in at least one portion of the sympathetic nervous system.

8. The method of claim 1, wherein said modulating is accomplished by administering an effective amount of at least one beta-blocker to said subject.

9. The method of claim 8, wherein said method comprises increasing said parasympathetic activity/sympathetic activity ratio.

10. The method of claim 1, further comprising performing said modulation of said at least one portion of the autonomic nervous system based on said determined parasympathetic activity/sympathetic activity ratio.

11. The method of claim 1, wherein said luteal phase is the late luteal phase.

12. The method according to claim 2, wherein said increasing parasympathetic activity comprises increasing activity in at least one parasympathetic nerve fiber.

13. The method according to claim 3, wherein said decreasing sympathetic activity comprises decreasing activity in at least one sympathetic nerve fiber.

14. The method according to claim 4, wherein said increasing parasympathetic activity comprises increasing activity in at least one parasympathetic nerve fiber.

15. The method according to claim 4, wherein said decreasing sympathetic activity comprises decreasing activity in at least one sympathetic nerve fiber.

16. The method according to claim 7, wherein said increasing activity in at least one portion of the parasympathetic nervous system comprises increasing activity in at least one parasympathetic nerve fiber.

17. The method according to claim 7, wherein said inhibiting activity in at least one portion of the sympathetic nervous system comprises inhibiting activity in at least one sympathetic nerve fiber.

18. The method according to claim 1, wherein said determining said parasympathetic activity/sympathetic activity ratio comprises determining heart rate variability (HRV) as an indicator of a parasympathetic/sympathetic activity ratio.

19. The method according to claim 1, wherein said determining said parasympathetic activity/sympathetic activity ratio comprises determining respiratory sinus arrhythmia as an indicator of a parasympathetic/sympathetic activity ratio.

20. The method according to claim 1, wherein said determining said parasympathetic activity/sympathetic activity ratio comprises determining an LF/HF ratio as an indicator of a parasympathetic/sympathetic activity ratio.

21. The method of claim 1, wherein said method further comprises a control feedback loop.

22. The method of claim 21, wherein said control feedback loop is an open-loop control system.

23. The method of claim 21, wherein said control feedback loop is a closed-loop control system.

24. The method of claim 21, wherein said control feedback loop comprises determining heart rate variability (HRV).

25. The method of claim 21, wherein said control feedback loop comprises determining respiratory sinus arrhythmia.

26. The method of claim 21, wherein said control feedback loop comprises determining an LF/HF ratio.

27. The method of claim 1, further comprising determining the occurrence of said luteal phase of said subject'"'"'s menstrual cycle.

28. The method of claim 1, wherein said administering is throughout all of said luteal phase.

29. A method of treating a female subject for a menopausal mood disorder or premenstrual mood disorder, said method consisting of:

modulating at least a portion of the autonomic nervous system of said subject during the luteal phase of the subject'"'"'s menstrual cycle to increase the parasympathetic activity/sympathetic activity ratio in a manner effective to treat said subject for said menopausal mood disorder or premenstrual mood disorder, wherein said modulating comprises (a) applying electrical energy during the luteal phase of the subject'"'"'s menstrual cycle to said at least one portion of said autonomic nervous system by transcutaneous electrical nerve stimulation (“

TENS”

) or (b) administering an effective amount of at least one beta blocker to said subject during the luteal phase of the subject'"'"'s menstrual cycle;

so that said subject is treated for said menopausal mood disorder or premenstrual mood disorder, wherein said menopausal mood disorder or premenstrual mood disorder is caused by an abnormal decrease in said parasympathetic activity/sympathetic activity ratio during said luteal phase,

and wherein said method further comprises determining said parasympathetic activity/sympathetic activity ratio at least one time during said luteal phase of said menstrual cycle.