Application of smooth pursuit cognitive testing paradigms to clinical drug development

• US 9,265,458 B2
• Filed: 12/04/2012
• Issued: 02/23/2016
• Est. Priority Date: 12/04/2012
• Status: Active Grant

• Current Assignee: NeuroSync, Inc.
• Original Assignee: Sync Think, Inc.
• Inventors: Stack, Matthew E.
• Primary Examiner(s): Frisby, Kesha
• Application Number:
  US13/694,461
• Publication Number:
  US 20140154650A1
• Time in Patent Office: 1,176 Days
• Field of Search: 434/236, 434/238
• US Class Current: 1/1
• CPC Class Codes: A61B 3/113 for determining or recording eye movement
• CPC Class Codes: A61B 5/162 Testing reaction times
• CPC Class Codes: A61B 5/163 by tracking eye movement, gaze, or pupil change
• CPC Class Codes: A61B 5/4076 Diagnosing or monitoring particular conditions of the nervous system A61B5/4821, A61B5/4824 take precedence
• CPC Class Codes: A61B 5/4848 Monitoring or testing the effects of treatment, e.g. of medication
• CPC Class Codes: G06F 3/013 Eye tracking input arrangements G06F3/015 takes precedence

Abstract

The invention describes the process of applying smooth pursuit eye movement tests toward the detection of the efficacy and, or, toxicity of neuro-pharmaceutical compounds throughout the clinical drug development process. Several different paradigms in smooth pursuit tracking tests and several analysis methods and metrics may be used. Application of smooth pursuit tracking tests allows for a quantifiable measurement of a subject'"'"'s cognitive behavior and function. This process provides a cost effective and objective test of efficacy of neuro-pharmaceutical drugs and increase the validity of the clinical drug development process.

Claims

1. A method for conducting pharmaceutical drug testing to ascertain the efficacy or toxicity of a candidate target drug comprising the steps of:

administering the target drug to a test subject and,

measuring the reaction of the test subject to the administration of the target drug utilizing smooth pursuit cognitive testing, wherein the smooth pursuit cognitive testing includes;

presenting a smoothly moving object on a screen;

using one or more cameras to detect gaze direction of one or more eyes of the test subject while the test subject visually tracks the smoothly moving object presented on the screen, and

determining cognitive performance of the test subject in accordance with the test subject'"'"'s performance in visually tracking the smoothly moving object presented on the screen.

2. The method of claim 1, and further including utilizing smooth pursuit cognitive testing prior to the introduction of the target drug into the test subject and determining a baseline therefrom.

3. The method of claim 2, wherein the smooth pursuit cognitive testing done after the introduction of the drug is compared to the baseline to determine if the drug has affected cognitive function or behavior.

4. The method of claim 3, wherein if cognitive function or behavior has been affected, clinical trial testing continues and wherein if no cognitive function or behavior affect has been determined, further product development of the drug is discontinued.

5. The method of claim 1, wherein presenting a smoothly moving object on a screen comprises presenting the moving object on a curvilinear path.

6. The method of claim 1, wherein the smooth pursuit cognitive testing includes calibration, target acquisition and a saccading test.

7. The method of claim 1, wherein the smooth pursuit cognitive testing includes a data cleansing step.

8. The method of claim 7, wherein the data cleansing step includes a filtration step that includes noise filtration and eliminates outlying data.

9. The method of claim 1, wherein the smooth pursuit cognitive testing includes cognitive metrics and data analysis that includes one of anticipatory timing, variability, regularity, predictability and peak performance.

10. The method of claim 9, wherein the cognitive metrics include a combination of two or more of anticipatory timing, variability, regularity, predictability and peak performance.

11. The method of claim 1, wherein the drug testing includes testing of a compound.

12. The method of claim 11, wherein the compound includes vitamins and non-drug classified substances.

13. A method of clinical drug testing, comprising the steps of:

providing a portable unit for performing an eye tracking function in which an individual is asked to peer into the unit and to visually track an icon moving on a screen within the unit; and

,

performing a smooth pursuit cognitive testing procedure to determine the affect of any administered target drug on the behavior of a test taking subject, wherein performing the smooth pursuit cognitive testing procedure includes;

presenting the moving icon on the screen within the unit;

using one or more cameras, located within the unit, to detect gaze direction of one or more eyes of the test taking subject while the test taking subject visually tracks the moving icon presented on the screen within the unit, and

determining cognitive performance of the test subject in accordance with the test taking subject'"'"'s performance in visually tracking the moving icon presented on the screen.

14. The method of claim 13, wherein if it is determined that the target drug has no effect on cognitive function or behavior on the test taking subject, then clinical drug testing for the target drug is discontinued.

15. The method of claim 14, wherein if it is determined that the target drug affects cognitive function or behavior of the test taking subject, then the effect in terms of test results is measured against a baseline previously established for the test taking subject.

16. The method of claim 15, and further including the step of correlating the test results with a physiological condition of the test taking subject.

17. The method of claim 16, wherein the correlation is utilized to provide a measure of the efficacy of the target drug.

18. The method of claim 16, wherein the correlation is made to deleterious reactions of the test taking subject to the administration of the target drug corresponding to toxicity.

19. A method for clinical drug testing comprising the steps of:

providing a mobile eye-tracking smooth pursuit cognitive testing unit;

administering a target drug to a test taking subject; and

in conjunction with administering the target drug to the test taking subject, monitoring cognitive function of the test taking subject utilizing the mobile unit, wherein monitoring cognitive function of the testing taking subject includes;

presenting a smoothly moving object on a screen in the mobile unit;

using one or more cameras, in the mobile unit, to detect gaze direction of one or more eyes of the test taking subject while the test taking subject visually tracks the smoothly moving object presented on the screen, and

determining cognitive performance of the test taking subject in accordance with the test taking subject'"'"'s performance in visually tracking the smoothly moving object presented on the screen.

20. The method of claim 19, wherein determining cognitive performance of the test taking subject includes determine one or more cognitive metrics including at least one of anticipatory timing, variability, regularity, predictability and peak performance.

21. The method of claim 20, wherein the unit includes a face mask to which the test taking subject presses his or her face, and wherein the test taking subject maintains positive pressure of his or her face against the face mask during smooth pursuit cognitive testing.