Selective neurostimulation for treating mood disorders

• US 20070027500A1
• Filed: 07/29/2005
• Published: 02/01/2007
• Est. Priority Date: 07/29/2005
• Status: Active Grant

• Current Assignee: LivaNova USA, Inc. (LivaNova Plc)
• Original Assignee: Cyberonics, Inc
• Inventors: Brannan, Stephen, Buras, William, Maschino, Steven
• Granted Patent: US 7,532,935 B2
• Time in Patent Office: Days
• US Class Current: 607/45
• CPC Class Codes: A61N 1/0529 Electrodes for brain stimulation
• CPC Class Codes: A61N 1/0531 Brain cortex electrodes
• CPC Class Codes: A61N 1/0534 Electrodes for deep brain stimulation
• CPC Class Codes: A61N 1/36082 Cognitive or psychiatric applications, e.g. dementia or Alzheimer's disease

Abstract

A method and device for treating a mood and/or anxiety disorder are disclosed which comprise electrical, chemical or magnetic stimulation of certain areas of the brain to modulate neuronal activity of areas associated with symptoms of mood disorders. In certain embodiments, deep brain stimulation is combined with cranial nerve stimulation to enhance symptomatic relief of the disorder. Certain embodiments also employ a sensing capability to optimize the therapeutic treatment regimen.

Claims

1. A method of treating an individual suffering from a mood disorder, the method comprising:

coupling a first stimulator to a stimulation site comprising a volume of neural tissue in an area of the individual'"'"'s brain selected from the group consisting of insula, subcallosal area, cingulate, thalamus, prefrontal cerebral cortex, brain stem, cerebellum, and white matter tracts leading to or from an aforementioned area;

coupling a second stimulator to a cranial nerve of the individual;

applying a first stimulation signal to said first stimulator such that said first stimulation signal causes modulation of the neuronal activity of neural tissue in said selected area of the brain;

applying a second stimulation signal to said second stimulator such that said second stimulation signal causes modulation of the neuronal activity in said cranial nerve, wherein said modulations cause amelioration of the mood disorder.

2. The method of claim 1 wherein said second stimulation signal causes selective parasympathetic afferents of the cranial nerves to be stimulated, whereby at least one cranial nerve pathway is affected causing a responsive effect on neural activity in at least one area of the brain to enhance amelioration of the mood disorder.

3. The method of claim 2 wherein said cranial nerve pathway is chosen from the group consisting of gustatory pathways, olfactory, pro-inflammatory or anti-inflammatory pathways, respiratory pathways, cardiac pathways, baroreceptor pathways, the somatosensory pathways, satiety pathways, and noradrenergic, serotoninergic, dopaminergic and cholinergic neurotransmitter pathways.

4. The method of claim 3 wherein said responsive effect on said area of the brain is excitatory or inhibitory and potentiates acute and/or long-term changes in neuronal activity of said area of the brain.

5. The method of claim 1 wherein said first and/or second stimulation signal causes modulation of neuronal activity in a neural tissue of said individual other than said area coupled to said first stimulator.

6. The method of claim 1 wherein said first stimulation signal comprises a first acute stimulation component and a first chronic stimulation component and/or said second stimulation signal comprises a second acute stimulation component and a second chronic stimulation component.

7. The method of claim 6 wherein said first acute stimulation component comprises a higher intensity level of stimulation and shorter duration than said first chronic stimulation component and/or said second acute stimulation component comprises a higher intensity level of stimulation and shorter duration than said second chronic stimulation component.

8. The method of claim 6 wherein said first and/or second acute stimulation component comprises a duration of one to six months.

9. The method of claim 1 wherein said cranial nerve is selected from the group consisting of vagus, trigeminal, hypoglossal and accessory nerves.

10. The method of claim 1 wherein said first stimulator is a first electrode and said second stimulator is a second electrode, and said method further comprises:

providing at least one programmable electrical signal generator coupled to said first and second electrodes;

programming said at least one electrical signal generator to define each of said first and second stimulation signals by a plurality of electrical parameters comprising a current magnitude, a pulse frequency, and a pulse width, wherein said parameters are selected to alleviate a symptom of said mood disorder.

11. The method of claim 1 wherein said first and/or second stimulator comprises at least one chemical dispensing assembly comprising a chemical-filled reservoir and a catheter in communication with a pump, said catheter comprising a dispensing end located on or near said nerve or brain area, and said first and/or second stimulation signal each comprises a therapeutic pumping signal, said method comprising:

operating at least one said pump such that said chemical contacts said cranial nerve and/or said brain area, whereby the neuronal activity of the contacted nerve and/or brain area is modified, and such modification of neuronal activity causes alleviation of a symptom of the mood disorder.

12. The method of claim 11 wherein said chemical agent is selected from the group consisting of inhibitory neurotransmitter agonists, excitatory neurotransmitter antagonists, agents that increase the level of an inhibitory neurotransmitter, agents that decrease the level of an excitatory neurotransmitter, and local anesthetic agents.

13. The method of claim 1 wherein said area comprises the insula or a white matter tract leading to a portion of the insula.

14. The method of claim 13 wherein said area comprises the left anterior insula, the left posterior insula, the right anterior insula, the left posterior insula, the claustrum, or a white matter tract leading to an aforementioned area.

15. The method of claim 1 wherein said area comprises at least a portion of the cingulate or a white matter tract leading to a portion of the cingulate.

16. The method of claim 1 wherein said area comprises at least a portion of a subcallosal area or a white matter tract leading to a portion of a subcallosal area.

17. The method of claim 1 wherein said area comprises at least a portion of a Brodmann area chosen from the group consisting of Brodmann area 24, Brodmann area 25 and Brodmann area 32.

18. The method of claim 1 wherein said area comprises at least a portion of the prefrontal cortex or a white matter tract leading to a portion of the prefrontal cortex.

19. The method of claim 18 wherein said area comprises the orbitofrontal cortex or a Brodmann area chosen from the group consisting of Brodmann area 8, Brodmann area 9, Brodmann area 10 and Brodmann area 11, or a white matter tract leading to the orbitofrontal cortex or an aforementioned Brodmann area.

20. The method of claim 1 wherein said area comprises at least a portion of the thalamus or a white matter tract leading to a portion of the thalamus.

21. The method of claim 1 wherein said area comprises a parafascicular nucleus or a white matter tract leading to a parafascicular nucleus.

22. The method of claim 1 wherein said area comprises at least a portion of the cerebellum, midbrain, or brainstem, or a white matter tract leading to a nucleus therein.

23. A method of treating an individual suffering from a mood disorder, the method comprising:

providing a controller comprising a signal generator and processor in communication with a first electrode and a second electrode;

coupling said first electrode to a cranial nerve of the individual;

coupling said second electrode to a volume of neural tissue in an area of the individual'"'"'s brain selected from the group consisting of insula, subcallosal area, cingulate, thalamus, hypothalamus, prefrontal cerebral cortex, brain stem, cerebellum, and white matter tracts leading from an aforementioned area;

applying a predetermined electrical signal to said first electrode; and

sensing electrical activity in said selected volume of brain tissue by said second electrode;

comparing the resulting sensed electrical activity to a predetermined electrical state of said selected area; and

determining from said comparison whether said application of said predetermined electrical signal to said first electrode causes a modulation of electrical activity of said brain area, wherein said modulation of electrical activity corresponds to alleviation of a symptom of a mood disorder.

24. The method of claim 23 wherein said cranial nerve is selected from the group consisting of vagus, trigeminal, hypoglossal and accessory nerves.

25. The method of claim 23 further comprising adjusting said predetermined signal according to said comparison results, to alter said modulation of neuronal activity in said selected brain area to enhance alleviation of a symptom of said mood disorder.

26. An adaptive brain stimulation process for treating a patient suffering from a mood disorder, the process comprising:

(a) providing a system comprising at least one sensor for coupling with a status indicator site on the patient to sense a present state of at least a first brain region or set of brain regions;

a first stimulating circuit for coupling at least said first brain region or set of brain regions by at least one stimulation electrode, to carry out stimulation according to a first set of stimulation parameters;

a comparator adapted for coupling with said at least one sensor, said comparator adapted for receiving data related to the present state and comparing said present state data with reference state data, such that said comparing results in a positive outcome or a negative outcome; and

at least one control circuit coupled with at least said first stimulating circuit and adapted for being adjusted according to the outcome of said comparing of said present and reference states, to control said stimulation parameters;

(b) coupling said at least one sensor with said a status indicator site on the patient;

(c) stimulating at least a first brain region or a first set of brain regions of the patient according to a first set of stimulation parameters;

(d) sensing a present state of said patient to provide sensed data;

(e) comparing said sensed data with reference state data to derive comparison results;

(f) determining from said comparison results whether a change in the stimulation parameters is necessary;

(g) if said change is necessary, determining what changes are to be made in said stimulation parameters;

(h) changing said first set of stimulation parameters as determined in step (f); and

(i) repeating steps (c)-(h) with the resulting changed stimulation parameters, until no further change is determined to be necessary in step (g).

27. The process of claim 26 further comprising stimulating a second brain region or a second set of brain regions of the patient if the comparison results indicate that a response signal causes a therapeutic benefit.

28. The process of claim 27 wherein said step of stimulating a second brain region or a second set of brain regions causes a beneficial therapeutic effect.

29. The a process of claim 26 wherein step (d) comprises sensing neuronal activity of a peripheral cranial nerve.

30. The process of claim 26 wherein, in step (g), changing said stimulation parameters comprises providing a stimulation signal that stimulates selective parasympathetic afferents of the cranial nerves to activate at least one cranial nerve pathway chosen from the group consisting of the gustatory pathways, olfactory, pro-inflammatory or anti-inflammatory pathways, respiratory pathways, cardiac pathways, baroreceptor pathways, the somatosensory pathways, satiety pathways, and noradrenergic, serotoninergic, dopaminergic and cholinergic neurotransmitter pathways.

31. A method of treating an individual suffering from a mood disorder, the method comprising:

applying a first therapeutic stimulation signal to a first stimulator that is coupled to a stimulation site comprising a volume of neural tissue in an area of the individual'"'"'s brain chosen from the group consisting of insula, brain stem, cerebellum, and white matter tracts leading to an aforementioned area, wherein said first stimulation signal causes modulation of the neuronal activity of said neural tissue, and said modulation of neuronal activity alleviates a symptom of the mood disorder or deters onset of said symptom.

32. The method of claim 31 wherein said first stimulator comprises an electrode and said first therapeutic stimulation signal comprises a first electrical signal, said method comprising:

coupling said electrode to said area of the individual'"'"'s brain; and

applying said first electrical signal to said electrode such that the neuronal activity of said neural tissue is modified, wherein such modification of neuronal activity alleviates a symptom of the mood disorder or deters onset of said symptom.

33. The method of claim 31 wherein said first therapeutic stimulation signal comprises an acute stimulation component and a chronic stimulation component.

34. The method of claim 33 wherein said acute stimulation component comprises a higher intensity level of stimulation and shorter duration than said chronic stimulation component.

35. The method of claim 33 wherein said acute stimulation component comprises a duration of one to six months.