# US 2014/0154650 A1 · Application of smooth pursuit cognitive testing paradigms to clinical drug development

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- Number: US 2014/0154650 A1
- Document ID: US20140154650A1
- Status: Published application
- Kind: A1
- Application number: 13/694,461
- Filed: 2012-12-04
- Published: 2014-06-05
- Earliest claimed: 2012-12-04
- Assignees: Sync-Think, Inc.
- Applicants: Sync-Think, Inc.
- Inventors: Matthew E. Stack
- Web page: https://patentgrep.com/patent/US20140154650A1

## CPC

- A61B 5/162: {Testing reaction times}
- A61B 5/163: {by tracking eye movement, gaze, or pupil change}
- A61B 5/4076: {Diagnosing or monitoring particular conditions of the nervous system}
- A61B 5/4848: {Monitoring or testing the effects of treatment, e.g. of medication}
- A61B 3/113: for determining or recording eye movement
- G06F 3/013: {Eye tracking input arrangements (G06F3/015 takes precedence)}
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- G06F: ELECTRIC DIGITAL DATA PROCESSING (computer systems based on specific computational models G06N)

## 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

### Claim 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.

### Claim 2 (depends on 1)

The method of claim 1, wherein the smooth pursuit cognitive testing includes eye tracking smooth pursuit cognitive testing.

### Claim 3 (depends on 1)

The method of claim 1, wherein the smooth pursuit cognitive testing includes mechanical smooth pursuit cognitive testing.

### Claim 4 (depends on 1)

The method of claim 1, wherein the smooth pursuit cognitive testing includes both eye tracking smooth pursuit cognitive testing and mechanical smooth pursuit cognitive testing.

### Claim 5 (depends on 1)

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.

### Claim 6 (depends on 5)

The method of claim 5, 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.

### Claim 7 (depends on 6)

The method of claim 6, 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.

### Claim 8 (depends on 1)

The method of claim 1, wherein the smooth pursuit cognitive testing includes providing a moving icon to be tracked by the test subject.

### Claim 9 (depends on 8)

The method of claim 8, wherein the path of the icon is a curvilinear path.

### Claim 10 (depends on 1)

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

### Claim 11 (depends on 1)

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

### Claim 12 (depends on 11)

The method of claim 11, wherein the data cleansing step includes a filtration step that includes noise filtration and eliminates outlying data.

### Claim 13 (depends on 1)

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.

### Claim 14 (depends on 13)

The method of claim 13, wherein the cognitive metrics include a combination of two or more of anticipatory timing, variability, regularity, predictability and peak performance.

### Claim 15 (depends on 1)

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

### Claim 16 (depends on 15)

The method of claim 15, wherein the compound includes vitamins and non-drug classified substances.

### Claim 17

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 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.

### Claim 18 (depends on 17)

The method of claim 17, 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.

### Claim 19 (depends on 18)

The method of claim 18, 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 subject.

### Claim 20 (depends on 19)

The method of claim 19, and further including the step of correlating the test results with a physiological condition of the test taking individual.

### Claim 21 (depends on 20)

The method of claim 20, wherein the correlation is utilized to provide a measure of the efficacy of the target drug.

### Claim 22 (depends on 20)

The method of claim 20, wherein the correlation is made to deleterious reactions of the test taking subject to the administration of the target drug corresponding to toxicity.

### Claim 23

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
monitoring the cognitive function or behavior of the test taking subject to the introduction of the target drug utilizing the mobile unit.

### Claim 24 (depends on 23)

The method of claim 23, wherein the smooth pursuit cognitive testing includes cognitive metrics including at least one of anticipatory timing, variability, regularity, predictability and peak performance.

### Claim 25 (depends on 24)

The method of claim 24, wherein the unit includes a face mask to which the test taking subject presses his or her face, and wherein the individual maintains positive pressure of his or her face against the face mask during smooth pursuit cognitive testing.

### Claim 26

Apparatus for use in clinical drug testing comprising smooth pursuit testing apparatus for testing the reaction of a test taking subject.

### Claim 27 (depends on 26)

The apparatus of claim 26, wherein said smooth pursuit cognitive test apparatus includes a screen with a moving icon thereon.

### Claim 28 (depends on 27)

The apparatus of claim 27, wherein the path of the moving icon is a curvilinear path.

### Claim 29 (depends on 28)

The apparatus of claim 28, wherein said smooth pursuit cognitive test apparatus includes eye tracking.

### Claim 30 (depends on 28)

The apparatus of claim 28, wherein said smooth pursuit cognitive test apparatus includes a mechanical input.

### Claim 31 (depends on 28)

The apparatus of claim 28, wherein said smooth pursuit cognitive test apparatus includes eye tracking and mechanical inputs.

### Claim 32 (depends on 26)

The apparatus of claim 26, wherein the cognitive metric used in said smooth pursuit cognitive test apparatus includes one of anticipatory timing, variability, regularity, predictability and peak performance.

### Claim 33 (depends on 26)

The apparatus of claim 26, wherein said smooth pursuit cognitive test apparatus includes a data cleansing module for cleansing the test results from said smooth pursuit cognitive test apparatus.

### Claim 34 (depends on 33)

The apparatus of claim 33, wherein said data cleansing module includes data filtration to detect noise infiltration and to remove outlying data.
