Method of treating depression, mood disorders and anxiety disorders using neuromodulation

• US 7,346,395 B2
• Filed: 06/18/2004
• Issued: 03/18/2008
• Est. Priority Date: 06/19/2003
• Status: Expired due to Term

• Current Assignee: Advanced Neuromodulation Systems Incorporated (Abbott Laboratories)
• Original Assignee: Advanced Neuromodulation Systems Incorporated (Abbott Laboratories)
• Inventors: Lozano, Andres M., Mayberg, Helen S.
• Primary Examiner(s): MANUEL, GEORGE C
• Application Number:
  US10/872,277
• Publication Number:
  US 20050027284A1
• Time in Patent Office: 1,369 Days
• Field of Search: 607/45, 607/3, 607/72, 604/890, 604/890.1
• US Class Current: 607/45
• CPC Class Codes: A61B 5/4848 Monitoring or testing the effects of treatment, e.g. of medication
• CPC Class Codes: A61M 5/14276 specially adapted for implantation
• CPC Class Codes: A61N 1/0534 Electrodes for deep brain stimulation
• CPC Class Codes: A61N 1/36096 Mood disorders, e.g. depression, anxiety or panic disorder
• CPC Class Codes: A61N 1/36185 Selection of the electrode configuration
• CPC Class Codes: A61P 25/00 Drugs for disorders of the nervous system
• CPC Class Codes: A61P 25/24 Antidepressants

Abstract

The present invention involves a method and a system for using electrical stimulation and/or chemical stimulation to treat depression. More particularly, the method comprises surgically implanting an electrical stimulation lead and/or catheter that is in communication with a predetermined site which is coupled to a signal generator and/or infusion pump that release either an electrical signal and/or a pharmaceutical resulting in stimulation of the predetermined site thereby treating the mood and/or anxiety.

Claims

1. A method of treating a mood and/or anxiety disorder comprising:

surgically implanting an electrical stimulation lead having a proximal end and a stimulation portion, wherein after implantation at least one electrode of the stimulation portion is positioned in or in direct contact with Brodmann area 25;

coupling the proximal end of the lead to a signal generator; and

generating an electrical signal with the signal generator for application to neural tissue of the patient using the at least one electrode wherein said signal electrically stimulates Brodmann area 25 thereby treating the mood and/or anxiety disorder.

2. The method of claim 1, wherein after implantation the at least one electrode is positioned about 0 mm to 10 mm below the intra-commissural line and 2 mm to 14 mm from midline.

3. The method of claim 1, wherein electrical stimulation of Brodmann area 25 results in modulation of neuronal activity in Brodmann area 9.

4. The method of claim 1, wherein electrical stimulation of Brodmann area 25 results in modulation of neuronal activity in Brodmann area 24.

5. The method of claim 1, wherein the mood disorder is selected from the group consisting of major depressive disorder, bipolar disorder, and dysthymic disorder.

6. The method of claim 1, wherein the mood disorder is major depressive disorder.

7. The method of claim 1, wherein the anxiety disorder is selected from the group consisting of panic disorder, posttraumatic stress disorder, obsessive-compulsive disorder and phobic disorder.

8. A method of treating a mood and/or anxiety disorder comprising:

surgically implanting an electrical stimulation lead having a proximal end and a stimulation portion, wherein after implantation at least one electrode of the stimulation portion is positioned in or in direct contact with Brodmann area 25;

surgically implanting a catheter having a proximal end coupled to a pump and a discharge portion for infusing a dosage of a pharmaceutical, wherein after implantation the discharge portion of the catheter is positioned in or in direct contact with Brodmann area 25;

coupling the proximal end of the lead to a signal generator;

generating an electrical signal with the signal generator and applying the electrical signal to electrically stimulate Brodmann area 25 using the at least one electrode; and

operating the pump to discharge the pharmaceutical through the discharge portion of the catheter into Brodmann area 25 thereby treating the mood and/or anxiety disorder.

9. A method of treating depression, mood disorder, and/or anxiety disorder in a patient, comprising:

identifying an approximate location of Brodmann area 25 of the patient utilizing an imaging system;

implanting a stimulation lead within the patient such that at least one electrode of the lead is no greater than approximately 1 cm from the center of Brodmann area 25;

coupling the lead to a pulse generator;

generating electrical pulses using the pulse generator;

conducting the electrical pulses from the pulse generator through the stimulation lead; and

applying the electrical pulses to stimulate neural tissue of Brodmann area 25 of the patient utilizing the at least one electrode of the stimulation lead, wherein the applying the electrical pulses effectively treats the depression, mood disorder, and/or anxiety disorder of the patient.

10. The method of claim 9 wherein the treatment of the depression, mood disorder, and/or anxiety disorder of the patient results in partial or complete remission of the depression, mood disorder, and/or anxiety disorder.

11. The method of claim 9 wherein the generating, conducting, and applying are performed on a chronic basis.

12. The method of claim 9 further comprising:

positioning an infusion port of a lead in direct contact with or directly in Brodmann area 25;

pumping a therapeutic agent through the lead; and

discharging the therapeutic agent from the infusion port to treat the depression, mood disorder, and/or anxiety disorder of the patient.

13. The method of claim 9 wherein the at least one electrode is positioned in direct contact with or directly within the gray matter portion of Brodmann area 25.

14. The method of claim 9, wherein after implantation the at least one electrode is positioned about 0 mm to 10 mm below the intra-commissural line and 2 mm to 14 mm from midline.

15. The method of claim 9, wherein the at least one electrode is positioned in direct contact with or directly within a white matter portion of Brodmann area 25.

16. The method of claim 9, wherein the center of Brodmann area 25 is further defined as having the coordinates of about 6 mm from the midline, about 29 mm anterior to the mid-commissural point, and about 5 mm below the intra-commissural line.

17. A method of treating depression in a patient, comprising:

identifying an approximate location of the subcallosal gyrus area of the patient utilizing an imaging system;

implanting a stimulation lead within the patient such that at least one electrode of the lead is positioned in direct contact with or directly in the subcallosal gyrus area;

generating electrical pulses using an implantable pulse generator (IPG) that is implanted within the patient;

conducting the electrical pulses from the IPG through a stimulation lead; and

applying the electrical pulses to stimulate neural tissue of the subcallosal gyrus area of the patient utilizing the at least one electrode of the stimulation lead, wherein the applying the electrical pulses effectively treats the depression of the patient.

18. The method of claim 17 wherein the treatment of the depression of the patient results in partial or complete remission of the depression.

19. The method of claim 17 wherein the generating, conducting, and applying are performed on a chronic basis.

20. The method of claim 17 further comprising:

positioning an infusion port of a lead in direct contact with or directly in the subcallosal gyrus;

pumping a therapeutic agent through the lead; and

discharging the therapeutic agent from the infusion port to treat the depression disorder of the patient.

21. The method of claim 17, wherein the subcallosal gyrus area comprises Brodmann area 25.

22. The method of claim 21 wherein the at least one electrode is implanted within a white matter tract contiguous with Brodmann area 25.

23. The method of claim 21 wherein the at least one electrode is implanted in direct contact with or directly within a gray matter portion of Brodmann area 25.

24. The method of claim 21, wherein the at least one electrode is implanted in direct contact with or directly within a white matter tract of Brodmann area 25.

25. The method of claim 17, wherein after implantation the at least one electrode of the stimulation portion is positioned about 0 mm to 10 mm below the intra-commissural line and 2 mm to 14 mm from midline.