Selective nerve stimulation for the treatment of eating disorders

• US 20070027498A1
• 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: Maschino, Steven E., Brannan, Stephen, Buras, William
• Granted Patent: US 7,499,752 B2
• Time in Patent Office: Days
• US Class Current: 607/45
• CPC Class Codes: A61M 2205/3523 using telemetric means
• CPC Class Codes: A61M 2205/3561 local, e.g. within room or hospital
• CPC Class Codes: A61M 5/14276 specially adapted for implantation
• CPC Class Codes: A61N 1/00 Electrotherapy; Circuits therefor A61N2/00 takes precedence; irradiation apparatus A61N5/00
• 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 1/36007 of urogenital or gastrointestinal organs, e.g. for incontinence control
• CPC Class Codes: A61N 1/36082 Cognitive or psychiatric applications, e.g. dementia or Alzheimer's disease

Abstract

A method and apparatus for treating persons suffering from an eating disorder includes direct or indirect stimulation of selected areas of the brain associated with a symptom of the eating disorder. The stimulation regimen is programmable to enable physician optimization of stimulation signal parameters to ameliorate at least one symptom of bulimia or another eating disorder. Certain embodiments employ deep brain stimulation and/or sensing together with cranial nerve stimulation and/or sensing.

Claims

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

applying a first therapeutic stimulation signal to a first stimulator that is coupled to a predetermined stimulation site comprising a volume of neural tissue in an area of the individual'"'"'s brain chosen from the group consisting of insula, subcallosal area, cingulate, thalamus, prefrontal cerebral cortex, 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 eating disorder.

2. The method of claim 1 wherein said first stimulator comprises an electrode and said first therapeutic stimulation signal comprises a first predetermined electrical signal, said method comprising:

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

applying said first predetermined 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 eating disorder.

3. The method of claim 1 wherein said first therapeutic stimulation signal comprises an acute stimulation component and a chronic stimulation component.

4. The method of claim 3 wherein said acute stimulation component comprises a higher intensity level of stimulation and shorter duration than said chronic stimulation component.

5. The method of claim 3 wherein said acute stimulation component comprises a duration of one to six months.

6. The method of claim 1 wherein first stimulation signal causes modulation of neuronal activity in a neural tissue of said individual other than said predetermined stimulation site.

7. The method of claim 1 comprising:

coupling said first stimulator to 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 an aforementioned area;

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

applying said first predetermined stimulatory signal to said first stimulator; and

applying a second predetermined stimulatory signal to said second stimulator, wherein said application of said first and second signals causes modulation of neuronal activity of said neural tissue to ameliorate the eating disorder.

8. The method of claim 7 wherein said second stimulatory signal comprises an acute stimulation component and a chronic stimulation component.

9. The method of claim 8 wherein said acute stimulation component comprises a higher intensity level of stimulation and shorter duration than said chronic stimulation component.

10. The method of claim 1 wherein said eating disorder is bulimia and said application of said first therapeutic stimulation signal alleviates binge eating and/or purging behavior in said individual.

11. The method of claim 1 wherein said application of said first therapeutic stimulation signal induces a feeling of satiety in said individual.

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

13. The method of claim 12 wherein said area comprises a portion of the insula chosen from the group consisting of the left and right anterior and posterior insula, and the claustrum, or a white matter tract leading to a portion of the insula.

14. 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.

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 15 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.

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

18. The method of claim 17 wherein said area comprises at least a portion of a Brodmann area chosen from the group consisting of Brodmann area 8, Brodmann area 9, Brodmann area 10 and Brodmann area 11.

19. The method of claim 1 wherein said area comprises at least one nucleus in the thalamus or a white matter tract leading to a nucleus in the thalamus.

20. A method of treating an individual suffering from an eating 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 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 area of the brain by said second electrode;

comparing the sensed electrical activity to a predetermined electrical state of said selected area, to provide comparison results; and

determining from said comparison results 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 an eating disorder.

21. The method of claim 20 wherein said first electrical signal comprises adjustable electrical parameters, and said method further comprises adjusting at least one parameter of said first electrical signal based on said comparison results.

22. The method of claim 20 wherein said step of sensing electrical activity in said selected area of the brain by said second electrode comprises subdural sensing.

23. The method of claim 20 wherein said cranial nerve is selected from the group consisting of vagus, hypoglossal, trigeminal and accessory nerves.

24. A method of treating an individual suffering from an eating 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 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 an aforementioned area;

applying a predetermined electrical signal to said second electrode to modulate neuronal activity of said selected area of the brain;

sensing electrical activity in said cranial nerve by said first electrode;

comparing the sensed electrical activity to a predetermined electrical state of said nerve, to yield comparison results;

determining from said comparison results whether said application of said predetermined electrical signal to said second electrode causes a modulation of electrical activity of said cranial nerve.

25. The method of claim 24 wherein said second electrical signal comprises adjustable electrical parameters, and said method further comprises adjusting at least one parameter of said second electrical signal based on said comparison results.

26. An adaptive brain stimulation process for treating a patient suffering from an eating 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), wherein no change is necessary when stimulation according to a changed set of stimulation parameters ameliorates a symptom of said eating disorder.

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.