Systems and methods for treating disorders of the central nervous system by modulation of brain networks

• US 7,894,903 B2
• Filed: 03/24/2006
• Issued: 02/22/2011
• Est. Priority Date: 03/24/2005
• Status: Active Grant

• Current Assignee: Michael Sasha John
• Original Assignee: Michael Sasha John
• Inventors: John, Michael Sasha
• Primary Examiner(s): Layno; Carl H
• Assistant Examiner(s): Bays; Pamela M
• Application Number:
  US11/308,440
• Publication Number:
  US 20060217781A1
• Time in Patent Office: 1,796 Days
• Field of Search: 607/2, 607/3, 607/45, 607/62, 607115-117, 607/139, 600/544, 600/545
• 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 1/36017 with leads or electrodes penetrating the skin
• 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: G16H 50/50 for simulation or modelling of medical disorders
• CPC Class Codes: G16Z 99/00 Subject matter not provided for in other main groups of this subclass

Abstract

The present invention involves methods and systems for treatment of brain disorders using neuromodulation that is provided to modulate structures of brain networks. Treatment occurs using electrical, optical, magnetic, and/or chemical stimulation of one or more brain networks associated with a brain disorder. The methods involve using a brain modulation system (BMS) to increase, decrease, or otherwise modulate characteristics of the regions of the network, such as relative levels of electrical activity or neurotransmitter levels. Treatment can be initiated and adjusted based upon evaluation of functional neuroimaging data for the network and brain network modeling. Linking rules may guide in adjusting the treatment protocol used to provide neuromodulation of multiple regions of a brain network. Novel methods are described for addressing issues of compensation, adaptation, and unintentional modulation due to indirect stimulation that can arise due to connectivity between structures within brain networks.

Claims

1. A method of treating at least one symptom of a brain disorder with a neurostimulation device comprising a first stimulator and a second stimulator, the method comprising:

operating the neurostimulation device to provide brain modulation of at least two regions of a brain network according to a treatment protocol;

wherein the modulation includes;

modulating a first brain region of the brain network using said first stimulator according to the treatment protocol configured with a first set of modulation parameters in order to provide treatment of the symptom;

modulating a second region of the brain network using said second stimulator according to the treatment protocol configured with a second set of modulation parameters in order to provide modulation to decrease a side-effect resulting at least in part from modulation in the first region; and

, wherein,

said brain network has least one brain region associated with the symptom for which treatment is sought.

2. The method of claim 1, wherein said treatment protocol uses linking rules for adjusting at least one modulation parameter, wherein the at least one modulation parameter is selected from at least one parameter of:

the first set of modulation parameters of the first stimulator for modulating a first brain region; and

, at least one parameter of the second set of modulation parameters of the second stimulator for modulating a second brain region.

3. The method of claim 2, wherein said linking rules are derived based upon at least one of:

imaging data;

sensed data obtained from at least one implanted sensor;

a behavioral assessment of the patient; and

subject report of the patient; and

a network model.

4. The method of claim 1, wherein brain modulation at least one of the at least two regions of the brain network occurs at least one of:

periodically;

continuously;

in response to a patient request inputted using a patient programmer;

according to a schedule or strategy defined in the treatment protocol; and

in response to the time of day.

5. The method of claim 1, wherein the side effect of modulating the first brain region relates to mood.

6. The method of claim 1, further including sensing data from at least one area of the brain network to obtain sensed data.

7. The method of claim 6, wherein brain modulation of at least one of the at least two regions of the brain network is adjusted as a function of at least one of:

the failure of sensed data to meet a treatment criterion;

the detection of an event within the sensed data;

the detection of a network event within the sensed data, and, a characteristic of a network event.

8. The method of claim 6 in which said treatment protocol is adjusted based upon an evaluation of sensed data, said data comprising at least one of:

the relative electrical activity in two or more regions of a network; and

, the relative chemical levels in two or more regions of a network.

9. The method of claim 8 wherein said chemical levels in the two or more regions may be measured for at least one of:

the same chemical; and

, different chemicals.

10. The method of claim 1 wherein said treatment protocol is adjusted based upon a comparison, said comparison being at least one of the following:

a. a comparison of the electrical activity in the first brain region of the brain network to the electrical activity in the second brain region of the brain network;

b. a comparison of the chemical activity in the first brain region of the brain network to the chemical activity in the second brain region of a brain network;

c. a comparison which includes both a and b; and

,

d. a comparison of the electrical activity in the first brain region of the brain network to the chemical activity in the second brain region of the brain network.

11. The method of claim 1, further including sensing data from at least one area of the brain network, and adjusting the treatment protocol, based upon an evaluation of sensed data, said evaluation resulting in one of:

a normal network state; and

, an abnormal network state.

12. The method of claim 1 wherein said treatment protocol is modified with parameter values intended to do at least one of the following:

increase neural activity;

decrease neural activity;

alter firing patterns of neural activity;

promote firing in a burst mode;

promote firing in a non-burst mode;

promote firing at a particular frequency; and

promote activation in response to activity sensed at one or more areas of the brain network, said one or more areas of the brain network being either proximate or distal to the site of stimulation.

13. The method of claim 6 wherein the brain disorder is a mood and/or anxiety disorder and wherein at least one sensed area is a brain area in a network which includes a subcallosal area.

14. The method of claim 1 wherein the brain disorder is a mood and/or anxiety disorder and wherein at least one target area is a brain area in a network which includes a subcallosal area.

15. The method of claim 1 wherein the treatment protocol provides at least one of:

electric, magnetic, chemical, optical or pharmaceutical treatment modulation of brain activity.

16. The method of claim 1, the method further comprising implanting a sensing subsystem configured to provide the neurostimulation device with sensed data.

17. The method of claim 1, wherein the at least one symptom of a brain disorder comprises a symptom that is associated with one of the following:

a major depressive disorder;

bipolar disorder;

dysthymic disorder, anxiety disorder;

panic disorder;

posttraumatic stress disorder;

phobic disorder;

psychiatric disorder psychosis;

schizophrenia; and

obsessive compulsive disorder.

18. The method of claim 1 wherein the brain disorder is an obsessive-compulsive disorder, and wherein the brain network includes the anterior limbs of the internal capsule, and wherein the first brain region of the brain network includes the anterior limbs of the internal capsule and wherein the second brain region of the brain network excludes the anterior limbs of the internal capsule.

19. The method of claim 1 further including operating a patient programmer to modify linking rules of at least of the said stimulation protocols used by said stimulation subsystem.

20. A neurostimulation system for treating at least one symptom of a brain disorder comprising:

a stimulation subsystem configured for providing brain modulation of a brain network using least a first and a second stimulator according to a treatment protocol;

wherein

the treatment protocol comprises;

modulating a first brain region of the brain network using a first set of modulation parameters that determines modulation provided by the first stimulator, said first set of modulation parameters designed to provide treatment of the symptom;

modulating a second region of the brain network using a second set of modulation parameters that determines modulation provided by the second stimulator, said second set of modulation parameters designed to provide stimulation to decrease a side-effect, resulting at least in part from modulation in the first area; and

, wherein,

said brain network has at least one brain region associated with the symptom for which treatment is sought.

21. The system of claim 20 wherein the system is further configured so that a first adjustment in at least one parameter used in the first set of modulation parameters causes a second adjustment in at least one parameter the second set of modulation parameters.

22. The system of claim 20 wherein said system further has a patient programmer which allows modification of linking rules of a stimulation protocol used by said stimulation subsystem to modulate the second region of the brain network.

23. The system of claim 20 wherein said stimulation subsystem is configured to be implantable.

24. The neurostimulation system of claim 20 further including a sensing subsystem configured for obtaining sensed data, and configured for evaluating the sensed data and for making an adjustment to at least one of:

said first set of modulation parameters said second set of modulation parameters;

said treatment protocol, or linking rule parameters used by said treatment protocol, based upon evaluation of said sensed data.

25. The neurostimulation system of claim 24 wherein said adjustment occurs according to a control law.