System and methods of deep brain stimulation for post-operation patients

• US 20070185544A1
• Filed: 01/16/2007
• Published: 08/09/2007
• Est. Priority Date: 01/13/2006
• Status: Active Grant

• Current Assignee: Vanderbilt University
• Original Assignee: Vanderbilt University
• Inventors: Konrad, Peter, D'Haese, Pierre-Francois, Dawant, Benoit
• Granted Patent: US 7,957,808 B2
• Time in Patent Office: Days
• US Class Current: 607/45
• 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 for programming a deep brain stimulator implanted in a target region of a brain of a living subject for optimal stimulation, wherein the deep brain stimulator comprises at least one electrode having a plurality of electrode contacts spaced apart from each other, and any portion of the brain of the living subject is identifiable by a set of corresponding spatial coordinates. In one embodiment, the method comprises the steps of creating an efficacy atlas in which any spatial coordinates for a position in a target region of the brain of the living subject are related to a position with corresponding atlas coordinates in the efficacy atlas, and each position in the atlas coordinates of the efficacy atlas is associated with an efficacy of stimulation at a corresponding position in the spatial coordinates of the brain of the living subject; acquiring a position of each electrode contact of the at least one electrode in the spatial coordinates of the brain of the living subject; mapping the acquired position of each electrode contact of the at least one electrode in the spatial coordinates of the brain of the living subject onto a corresponding position in the efficacy atlas so as to determine the efficacy of stimulation at the acquired position in the spatial coordinates of the brain of the living subject; and selecting one or more electrode contacts having the highest efficacy for stimulation.

Claims

1. A method for programming a deep brain stimulator implanted in a target region of a brain of a living subject for optimal stimulation, wherein the deep brain stimulator comprises at least one electrode having a plurality of electrode contacts spaced apart from each other, and wherein any portion of the brain of the living subject is identifiable by a set of corresponding spatial coordinates, comprising the steps of:

a. creating an efficacy atlas in which any spatial coordinates for a position in a target region of the brain of the living subject are related to a position with corresponding atlas coordinates in the efficacy atlas, and each position in the atlas coordinates of the efficacy atlas is associated with an efficacy of stimulation at a corresponding position in the spatial coordinates of the brain of the living subject;

b. acquiring a position of each electrode contact of the at least one electrode in the spatial coordinates of the brain of the living subject;

c. mapping the acquired position of each electrode contact of the at least one electrode in the spatial coordinates of the brain of the living subject onto a corresponding position in the efficacy atlas so as to determine the efficacy of stimulation at the acquired position in the spatial coordinates of the brain of the living subject; and

d. selecting one or more electrode contacts having the highest efficacy for stimulation.

2. The method of claim 1, wherein the efficacy of stimulation at a position in the spatial coordinates of the brain of the living subject is

a. proportional to a percent of loss of rigidity, L^R;

b. proportional to a therapeutic window that equals to the difference between a voltage, V, applied to the position for achieving the loss of rigidity and a voltage, V^SE, applied to the position for which side effects occur; and

c. inversely proportional to the voltage V.

3. The method of claim 2, wherein the efficacy of stimulation at a position is corresponding to the probability of the stimulation to be clinically effective at the position.

4. The method of claim 1, wherein the creating step comprises the steps of:

a. obtaining stimulation data corresponding to a target region in which a deep brain stimulator is implanted from a database, wherein the stimulation data comprise M×

N sets of intra-operatively acquired stimulation signals, {V_ij, L_ij^R, V_ij^SE}, and their corresponding stimulation positions, {x_j, y_j, z_j}, wherein i=1, 2, . . . , M, M being a positive integer and the number of a population of living subjects from which the stimulation signals are acquired and stored in the database, and j=1, 2, . . . , N, N being a positive integer and the number of positions at which the stimulation takes place for each of the population of living subjects, and wherein V_ij, L_ij^R, V_ij^SE are a stimulation voltage, a percent of loss of rigidity caused by the stimulation voltage, and a voltage for which side effects occur, respectively, at the j-th stimulation position of the i-th living subject;

b. choosing a local efficacy of stimulation, E_ij, at the j-th stimulation position (x_j, y_j, z_j) for the i-th living subject with a Gaussian curve, F_ij, in the form of;

$F_{\mathrm{ij}}=E_{\mathrm{ij}}*\exp <br><br>\left[-\left(\frac{x_j^2+y_j^2+z_j^2}{2<br><br>\text{\hspace{1em}<br><br>}<br><br>V_{\mathrm{ij}}^2}\right)\right],$

wherein the local efficacy of stimulation

$E_{\mathrm{ij}}=L_{\mathrm{ij}}^R*\left(V_{\mathrm{ij}}^{\mathrm{SE}}-V_{\mathrm{ij}}\right)*\frac{1}{V_{\mathrm{ij}}};<br><br>$

and

wherein the height of the Gaussian curve F_ij is a function of the local efficacy of stimulation E_ij, and the radius of the Gaussian curve F_ij is a function of the stimulation voltage V_ij;

c. repeating step (b) for each of the population of living subjects, i=1, 2, . . . , M, so as to obtain M sets of Gaussian curves {F_ij} for the j-th stimulation position (x_j, y_j, z_j);

d. averaging the M sets of Gaussian curves {F_ij} to obtain an efficacy of stimulation at the j-th stimulation position (x_j, y_j, z_j), which is equal to the mean value of the M sets of Gaussian curves {F_ij}; and

e. repeating steps (b)-(d) for each of the stimulation positions, j=1, 2, . . . , N, to obtain N efficacies of stimulation respectively for the N stimulation positions, thereby creating the efficacy atlas.

5. The method of claim 4, wherein the efficacy atlas comprises at least one stimulation map having at least one stimulation region corresponding to the target region of the brain of the living subject for optimal stimulation.

6. The method of claim 4, wherein the database comprises an electrophysiological atlas containing electrophysiological information acquired from each of the population of living subjects and related to atlas coordinates of the electrophysiological atlas.

7. The method of claim 6, wherein the atlas coordinates of the efficacy atlas is substantially coincident with the atlas coordinates of the electrophysiological atlas.

8. The method of claim 6, wherein the electrophysiological information comprises at least intra-operative information for each of the population of living subjects.

9. The method of claim 8, wherein the intra-operative information comprises at least specific information associated with at least one stimulation electrode, wherein the specific information includes voltages applied to the at least one stimulation electrode, a response of a living subject undergoing treatment to the stimulation, differences in voltage between disappearance of symptoms and appearance of side effects, and a position of the at least one stimulation electrode.

10. The method of claim 9, wherein the response of the living subject undergoing treatment to the stimulation includes loss of rigidity, location where the loss of rigidity is observed, appearance of side effects, and/or location affected by these side effects.

11. The method of claim 8, wherein the intra-operative information comprises at least specific information associated with a deep brain stimulator having at least one electrode, wherein the specific information includes a position of each electrode contact of the at least one electrode, and a voltage, frequency and pulse width of stimulation at the position.

12. The method of claim 11, wherein the acquiring step comprises the step of obtaining the position of each electrode contact of the at least one electrode from the database.

13. The method of claim 1, wherein the acquiring step comprises the step of acquiring the position of each electrode contact of the at least one electrode post-operatively from the target region of the brain of the living subject in which the deep brain stimulator is implanted.

14. The method of claim 1, wherein the mapping step is performed with a non-rigid registration algorithm.

15. A system for programming a deep brain stimulator implanted in a target region of a brain of a living subject for optimal stimulation, wherein the deep brain stimulator comprises at least one electrode having a plurality of electrode contacts spaced apart from each other, and wherein any portion of the brain of the living subject is identifiable by a set of corresponding spatial coordinates, comprising:

a. an efficacy atlas in which each position in the atlas coordinates of the efficacy atlas is associated with an efficacy of stimulation at a corresponding position in the spatial coordinates of the brain of the living subject;

b. means for acquiring a position of each electrode contact of the at least one electrode in the spatial coordinates of the brain of the living subject; and

c. a controller at least communicable with the efficacy atlas and adapted for mapping the acquired position of each electrode contact of the at least one electrode in the spatial coordinates of the brain of the living subject onto a corresponding position in the atlas coordinates of the efficacy atlas so as to determine the efficacy of stimulation at the acquired position in the spatial coordinates of the brain of the living subject, and selecting one or more electrode contacts having the highest efficacy for stimulation.

16. The system of claim 15, wherein the efficacy of stimulation at a position in the spatial coordinates of the brain of the living subject is

a. proportional to a percent of loss of rigidity, L^R;

b. proportional to a therapeutic window that equals to the difference between a voltage, V, applied to the position for achieving the loss of rigidity and a voltage, V^SE, applied to the position for which side effects occur; and

c. inversely proportional to the voltage V.

17. The system of claim 16, wherein the efficacy of stimulation at a position is corresponding to the probability of the stimulation to be clinically effective at the position.

18. The system of claim 15, further comprising a data storage device for storing the efficacy atlas, the data storage device configured to be in communication with the controller.

19. The system of claim 18, further comprising a database stored in the data storage device, wherein the database comprises an electrophysiological atlas containing electrophysiological information acquired from a brain of each of a population of living subjects and related to atlas coordinates of the electrophysiological atlas.

20. The system of claim 19, wherein the atlas coordinates of the efficacy atlas is substantially coincident with the atlas coordinates of the electrophysiological atlas.

21. The system of claim 19, wherein the electrophysiological information comprises at least intra-operative information for each of the population of living subjects.

22. The system of claim 21, wherein the intra-operative information comprises at least specific information associated with at least one stimulation electrode, wherein the information includes voltages applied to the at least one stimulation electrode, a response of a living subject undergoing treatment to the stimulation, differences in voltage between disappearance of symptoms and appearance of side effects, and a position of the at least one stimulation electrode.

23. The system of claim 22, wherein the response of the living subject undergoing treatment to the stimulation includes loss of rigidity, location where the loss of rigidity is observed, appearance of side effects, and/or location affected by these side effects.

24. The system of claim 23, wherein the efficacy atlas is created by the steps of:

a. obtaining stimulation data corresponding to a target region in which a deep brain stimulator is implanted from the database, wherein the stimulation data comprise M×

N sets of intra-operatively acquired stimulation signals, {V_ij, L_ij^R, V_ij^SE}, and their corresponding stimulation positions, {x_j, y_j, z_j}, wherein i=1, 2, . . . , M, M being a positive integer and the number of the population of living subjects from which the stimulation signals are acquired and stored in the database, and j=1, 2, . . . , N, N being a positive integer and the number of positions at which the stimulation takes place for each of the population of living subjects, and wherein V_ij, L_ij^R, V_ij^SE are a stimulation voltage, a percent of loss of rigidity caused by the stimulation voltage, and a voltage for which side effects occur, respectively, at the j-th stimulation position of the i-th living subject;

b. choosing a local efficacy of stimulation, E_ij, at the j-th stimulation position (x_j, y_j, z_j) for the i-th living subject with a Gaussian curve, F_ij, in the form of;

$F_{\mathrm{ij}}=E_{\mathrm{ij}}*\exp <br><br>\left[-\left(\frac{x_j^2+y_j^2+z_j^2}{2<br><br>\text{\hspace{1em}<br><br>}<br><br>V_{\mathrm{ij}}^2}\right)\right],$

wherein the local efficacy of stimulation

$E_{\mathrm{ij}}=L_{\mathrm{ij}}^R*\left(V_{\mathrm{ij}}^{\mathrm{SE}}-V_{\mathrm{ij}}\right)*\frac{1}{V_{\mathrm{ij}}};<br><br>$

and wherein the height of the Gaussian curve F_ij is a function of the local efficacy of stimulation E_ij, and the radius of the Gaussian curve F_ij is a function of the stimulation voltage V_ij;

i. repeating step (b) for each of the population of living subjects, i=1, 2, . . . , M, so as to obtain M sets of Gaussian curves {F_ij} for the j-th stimulation position (x_j, y_j, z_j);

ii. averaging the M sets of Gaussian curves {F_ij} to obtain an efficacy of stimulation at the j-th stimulation position (x_j, y_j, z_j), which is equal to the mean value of the M sets of Gaussian curves {F_ij}; and

iii. repeating steps (b)-(d) for each of the stimulation positions, j=1, 2, . . . , N, to obtain N efficacies of stimulation respectively for the N stimulation positions, thereby creating the efficacy atlas.

25. The system of claim 24, wherein the efficacy atlas comprises at least one stimulation map having at least one stimulation region related to the target region of the brain of the living subject for optimal stimulation.

26. The system of claim 21, wherein the intra-operative information comprises at least specific information associated with a deep brain stimulator implanted in a target region of a brain of a living subject, wherein the specific information includes a position of each electrode contact of the deep brain stimulator, and a voltage, frequency and pulse width of stimulation at the position.

27. The system of claim 26, wherein the acquiring means comprises a device for obtaining the position of each electrode contact of the at least one electrode from the database.

28. The system of claim 15, wherein the acquiring means comprises a device for acquiring the position of each electrode contact of the at least one electrode post-operatively from the target region of the brain of the living subject in which the deep brain stimulator is implanted.

29. The system of claim 15, further comprising a non-rigid registration algorithm stored in a memory that is in communication with the controller.

30. A method for programming a deep brain stimulator implanted in a target region of a brain of a living subject for optimal stimulation, wherein the deep brain stimulator comprises at least one electrode having a plurality of electrode contacts, comprising the step of:

a. creating an efficacy atlas in which a position in atlas coordinates of the efficacy atlas is related to a corresponding position in spatial coordinates of the brain of the living subject, and each position in atlas coordinates of the efficacy atlas is associated with an efficacy of stimulation at a corresponding position in spatial coordinates of the brain of the living subject.

31. The method of claim 30, wherein the creating step comprises the steps of:

a. obtaining stimulation data corresponding to a target region in which a deep brain stimulator is implanted from a database, wherein the stimulation data comprise M×

N sets of intra-operatively acquired stimulation signals, {V_ij, L_ij^R, V_ij^SE)}, and their corresponding stimulation positions, {x_j, y_j, z_j}, wherein i=1, 2, . . . , M, M being a positive integer and the number of a population of living subjects from which the stimulation signals are acquired and stored in the database, and j=1, 2, . . . , N, N being a positive integer and the number of positions at which the stimulation takes place for each of the population of living subjects, and wherein V_ij, L_ij^R, V_ij^SE are a stimulation voltage, a percent of loss of rigidity caused by the stimulation voltage, and a voltage for which side effects occur, respectively, at the j-th stimulation position of the i-th living subject;

b. choosing a local efficacy of stimulation, E_ij, at the j-th stimulation position (x_j, y_j, z_j) for the i-th living subject with a Gaussian curve, F_ij, in the form of;

$F_{\mathrm{ij}}=E_{\mathrm{ij}}*\exp <br><br>\left[-\left(\frac{x_j^2+y_j^2+z_j^2}{2<br><br>\text{\hspace{1em}<br><br>}<br><br>V_{\mathrm{ij}}^2}\right)\right],$

wherein the local efficacy of stimulation

$E_{\mathrm{ij}}=L_{\mathrm{ij}}^R*\left(V_{\mathrm{ij}}^{\mathrm{SE}}-V_{\mathrm{ij}}\right)*\frac{1}{V_{\mathrm{ij}}};<br><br>$

and

wherein the height of the Gaussian curve F_ij is a function of the local efficacy of stimulation E_ij and the radius of the Gaussian curve F_ij is a function of the stimulation voltage V_ij;

c. repeating step (b) for each of the population of living subjects, i=1, 2, . . . , M, so as to obtain M sets of Gaussian curves {F_ij} for the j-th stimulation position (x_j, y_j, z_j);

d. averaging the M sets of Gaussian curves {F_ij} to obtain an efficacy of stimulation at the j-th stimulation position (x_j, y_j, z_j), which is equal to the mean value of the M sets of Gaussian curves {F_ij}; and

e. repeating steps (b)-(d) for each of the stimulation positions, j=1, 2, . . . , N, to obtain N efficacies of stimulation respectively for the N stimulation positions, thereby creating an efficacy atlas.

32. The method of claim 31, wherein the efficacy atlas comprises at least one stimulation map having at least one stimulation region related to the target region of the brain of the living subject for optimal stimulation.

33. The method of claim 31, wherein the database comprises an electrophysiological atlas containing electrophysiological information acquired from each of the population of living subjects and related to atlas coordinates of the electrophysiological atlas.

34. The method of claim 31, wherein the atlas coordinates of the efficacy atlas is substantially coincident with the atlas coordinates of the electrophysiological atlas.

35. The method of claim 31, further comprising the steps of:

a. mapping a position of each electrode contact of the at least one electrode in the spatial coordinates of the brain of the living subject onto a corresponding position in the atlas coordinates of the efficacy atlas so as to determine the efficacy of stimulation at the acquired position in the spatial coordinates of the brain of the living subject; and

b. selecting one or more electrode contacts having the highest efficacy for stimulation.

36. The method of claim 35, wherein the mapping step is performed with a non-rigid registration algorithm.

37. A system for programming a deep brain stimulator implanted in a target region of a brain of a living subject for optimal stimulation, wherein the deep brain stimulator comprises at least one electrode having a plurality of electrode contacts spaced apart from each other, and wherein any portion of the brain of the living subject is identifiable by a set of corresponding spatial coordinates, comprising:

a. a data storage device;

b. a database stored in the data storage device, comprising an electrophysiological atlas containing electrophysiological information acquired from each of the population of living subjects and related to atlas coordinates of the electrophysiological atlas; and

c. a controller in communication with the data storage device and adapted for programmably interfacing with the database for creating an efficacy atlas in which a position in atlas coordinates of the efficacy atlas is related to a corresponding position in spatial coordinates of the brain of the living subject, and vice versa, and each position in atlas coordinates of the efficacy atlas is associated with an efficacy of stimulation at a corresponding position in spatial coordinates of the brain of the living subject.

38. The system of claim 37, wherein the efficacy atlas comprises at least one stimulation map having at least one stimulation region related to the target region of the brain of the living subject for optimal stimulation.

39. The system of claim 37, wherein the atlas coordinates of the efficacy atlas is substantially coincident with the atlas coordinates of the electrophysiological atlas.

40. The system of claim 37, wherein the controller is adapted for programmably mapping a position of each electrode contact of the at least one electrode in the spatial coordinates of the brain of the living subject onto a corresponding position in the atlas coordinates of the efficacy atlas so as to determine the efficacy of stimulation at the acquired position in the spatial coordinates of the brain of the living subject, and selecting one or more electrode contacts having the highest efficacy for stimulation.

41. A system for programming a deep brain stimulator implanted in a target region of a brain of a living subject for optimal stimulation, wherein the deep brain stimulator comprises at least one electrode having a plurality of electrode contacts, and wherein any portion of the brain of the living subject is identifiable by a set of corresponding spatial coordinates, comprising:

a. a data storage device; and

b. an efficacy atlas stored in the data storage device, wherein each position in atlas coordinates of the efficacy atlas is associated with an efficacy of stimulation at a corresponding position in spatial coordinates of the brain of the living subject.

42. The system of claim 41, wherein the efficacy atlas comprises at least one stimulation map having at least one stimulation region related to the target region of the brain of the living subject for optimal stimulation.

43. The system of claim 41, further comprising a controller in communication with the data storage device and adapted for programmably mapping a position of each electrode contact of the at least one electrode in the spatial coordinates of the brain of the living subject onto a corresponding position in the atlas coordinates of the efficacy atlas so as to determine the efficacy of stimulation at the acquired position in the spatial coordinates of the brain of the living subject, and selecting one or more electrode contacts having the highest efficacy for stimulation.

44. Software stored on a computer readable medium for causing a computing system to perform functions comprising:

a. creating an efficacy atlas in which a position in atlas coordinates of the efficacy atlas is related to a corresponding position in spatial coordinates of the brain of the living subject, and each position in the atlas coordinates of the efficacy atlas is associated with an efficacy of stimulation at a corresponding position in the spatial coordinates of the brain of the living subject;

b. acquiring a position of each electrode contact of the at least one electrode in the spatial coordinates of the brain of the living subject;

c. mapping the acquired position of each electrode contact of the at least one electrode in the spatial coordinates of the brain of the living subject onto a corresponding position in the atlas coordinates of the efficacy atlas so as to determine the efficacy of stimulation at the acquired position in the spatial coordinates of the brain of the living subject; and

d. selecting one or more electrode contacts having the highest efficacy for stimulation.