Systems and methods for electrical stimulation-related patient population volume analysis and use

• US 10,265,528 B2
• Filed: 07/30/2015
• Issued: 04/23/2019
• Est. Priority Date: 07/30/2014
• Status: Active Grant

• Current Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Inventors: Carcieri, Stephen, Steinke, G. Karl, Yoo, Peter J., Mustakos, Richard, Bokil, Hemant
• Primary Examiner(s): Vanni, G Steven
• Application Number:
  US14/813,734
• Publication Number:
  US 20160030749A1
• Time in Patent Office: 1,363 Days
• Field of Search: None
• CPC Class Codes: A61N 1/0534 Electrodes for deep brain stimulation
• CPC Class Codes: A61N 1/0551 Spinal or peripheral nerve electrodes
• CPC Class Codes: A61N 1/36128 Control systems
• CPC Class Codes: A61N 1/36185 Selection of the electrode configuration
• CPC Class Codes: A61N 1/37247 User interfaces, e.g. input or presentation means
• CPC Class Codes: G16H 30/40 for processing medical images, e.g. editing
• CPC Class Codes: G16H 50/20 for computer-aided diagnosis, e.g. based on medical expert systems
• CPC Class Codes: G16H 50/50 for simulation or modelling of medical disorders

Abstract

A computer implemented system and method facilitates a cycle of generation, sharing, and refinement of volumes related to stimulation of anatomical tissue, such as brain or spinal cord stimulation. Such volumes can include target stimulation volumes, side effect volumes, and volumes of estimated activation. A computer system and method also facilitates analysis of groups of volumes, including analysis of differences and/or commonalities between different groups of volumes.

Claims

1. A computer-implemented method, comprising:

obtaining user input of a clinical effect, wherein the clinical effect is either a therapeutic effect or a side effect;

obtaining a plurality of estimated volumes of activation (VOA) associated with electrical stimulations of a patient population, wherein a first group of the VOAs is associated with the clinical effect and a second group of the VOAs is not associated with the clinical effect;

based on the VOAs, determining a target stimulation region when the clinical effect is the therapeutic effect or determining a side effect region when the clinical effect is the side effect, wherein either determining comprises determining, on a voxel-by-voxel basis, that a voxel is in the target stimulation region or side effect region when the voxel is included in statistically significantly more of the VOAs of the first group of VOAs than in the VOAs of the second group of VOAs; and

outputting the determined target stimulation region or side effect region.

2. The computer-implemented method of claim 1, further comprising transforming all of the VOAs into a common spatial reference space.

3. The computer-implemented method of claim 2, wherein the common spatial reference space is generated from a group of patients with one or more specified characteristics in common with a current patient.

4. The computer-implemented method of claim 2, wherein the common spatial reference space is generated from a group of patients associated with similar VOAs that produced the clinical effect.

5. The computer-implemented method of claim 1, further comprising obtaining a rating for each of the VOAs with respect to the clinical effect, wherein determining a target stimulation region or a side effect region comprises selecting points for the target stimulation region or side effect region, wherein each of the points has a score equal to or higher than a threshold score, wherein the score is based on the VOAs containing the respective point weighted by the rating of the VOAs containing that respective point.

6. The computer implemented method of claim 5, wherein outputting the determined target stimulation region or side effect region comprises outputting the determined target stimulation region or side effect region indicating a probability, based on the scores for points within the determined target stimulation region or side effect region, that stimulation of the target stimulation region or side effect region will contribute to the clinical effect.

7. The computer-implemented method of claim 1, further comprising filtering the VOAs by a time of day when electrical stimulation of each VOA was performed.

8. The computer-implemented method of claim 1, further comprising filtering the VOAs by a medication used by a patient associated with each VOA.

9. The computer-implemented method of claim 1, wherein the clinical effect is the therapeutic effect.

10. The computer-implemented method of claim 1, further comprising generating a probability voxel map that maps a probability that electrical stimulation of each respective voxel of the probability voxel map will contribute to the clinical effect.

11. The computer-implemented method of claim 1, further comprising, for the first group of the VOAs, determining an overlap of a significant number of the VOAs with a shared component of a biological circuit element.

12. The computer-implemented method of claim 11, further comprising, based on a degree of the overlap, outputting an indication of the biological circuit element as associate with the clinical effect.

13. The computer-implemented method of claim 11, further comprising generating a new target stimulation region, when the clinical effect is therapeutic effect, or new side effect region, when the clinical effect is a side effect, based on the VOAs which overlap the biological circuit element.

14. The computer-implemented method of claim 11, further comprising displaying a biological circuit that includes the biological circuit element.

15. The computer-implemented method of claim 1, further comprising filtering the VOAs to include only VOAs in the first and second groups that correspond to patients having a same medication.

16. The computer-implemented method of claim 1, further comprising filtering the VOAs to include only VOAs in the first and second groups that correspond to patients having a same medication and dosage.

17. The computer-implemented method of claim 1, further comprising filtering the VOAs to include only VOAs in the first and second groups that correspond to electrical stimulations performed at a same period in the day.

18. The computer implemented method of claim 17, further comprising analyzing the VOAs of the first group based on a time of day that electrical stimulation occurred to determine a target stimulation time.

19. The computer implemented method of claim 18, further comprising creating a histogram of electrical stimulations associated with the VOAs of the first group by time of day.

20. The computer implemented method of claim 1, wherein the steps are performed separately for both a therapeutic effect and a side effect to determine a target stimulation region and a side effect region, respectively.