# US 9,039,631 B2 · Quantitative, non-invasive, clinical diagnosis of traumatic brain injury using VOG device for neurologic testing

> Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt

- Number: US 9,039,631 B2
- Document ID: US9039631B2
- Status: Granted
- Kind: B2
- Application number: 14/083,145
- Filed: 2013-11-18
- Published: 2014-07-10
- Granted: 2015-05-26
- Earliest claimed: 2008-10-09
- Assignees: Neuro Kinetics, Inc.
- Applicants: Neuro Kinetics, Inc.
- Inventors: Alexander D Kiderman; Howison Schroeder; Thomas Joos; Greg Frank; Daniel Sweeney; Thomas Vernon Baker
- Web page: https://patentgrep.com/patent/US9039631B2

## CPC

- A61B 3/113: for determining or recording eye movement
- A61B 3/0041: {characterised by display arrangements}
- A61B 3/02: Subjective types, i.e. testing apparatus requiring the active assistance of the patient
- A61B 5/16: Devices for psychotechnics (using teaching or educational appliances G09B1/00 - G09B7/00); Testing reaction times {; Devices for evaluating the psychological state}
- A61B 5/163: {by tracking eye movement, gaze, or pupil change}
- A61B 5/4064: {Evaluating the brain (for intracranial pressure A61B5/031; for cerebral blood gases A61B5/14553; using EEG A61B5/369)}
- A61B 5/6803: {Head-worn items, e.g. helmets, masks, headphones or goggles}
- G02B 27/017: {Head mounted}
- G02C 5/001: {specially adapted for particular purposes, not otherwise provided for or not fully classifiable according to technical characteristics, e.g. therapeutic glasses}
- A61B 3/032: Devices for presenting test symbols or characters, e.g. test chart projectors (A61B3/036 takes precedence)
- A61B 5/4863: {Measuring or inducing nystagmus}
- G02B 27/0093: {with means for monitoring data relating to the user, e.g. head-tracking, eye-tracking}
- G02B 2027/0138: {comprising image capture systems, e.g. camera}
- G02B 2027/014: {comprising information/image processing systems}
- G02B 2027/0187: {slaved to motion of at least a part of the body of the user, e.g. head, eye}
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- G02B: OPTICAL ELEMENTS, SYSTEMS OR APPARATUS
- G02C: SPECTACLES; SUNGLASSES OR GOGGLES INSOFAR AS THEY HAVE THE SAME FEATURES AS SPECTACLES; CONTACT LENSES (trial frames for testing the eyes A61B3/04; goggles or eyeshields not having the same features as spectacles A61F9/00)

## Abstract

A portable VOG device is disclosed that will facilitate the effective and efficient screening for TBI in military personnel in forward deployed military settings or remote locations using minimally trained staff. This includes the establishment of a protocol that will provide cost effective pre-screening of military personnel prior to deployment to establish a baseline of brain function prior to possible future injury. The efficiency of the device will promote subsequent follow-up screening to assess the effectiveness of prescribed TBI treatment. Further protocols for diagnosis and rehabilitation applications using the same virtual reality portable device will allow more advanced usage for clinicians providing ongoing evaluation and treatment.

## Claims

### Claim 1

A method of diagnosis of mild traumatic brain injury or concussion in a subject comprising the steps of:
A) providing a system including a stimulus generating portion and an eye tracking portion;
B) presenting visual stimulus to the subject via the stimulus generating portion, wherein the visual stimulus presented to the subject via the stimulus generating portion forms the optical target stimulus for at least two distinct categories of tests including at least two from the following categories of tests i) nystagmus tests, ii) smooth pursuit tests, and iii) optokinetic tests;
C) obtaining objective physiologic response of the subject in the form of reflexive responses and/or voluntary ocular-motor responses of the subject's eyes from the eye tracking portion based upon each of the visual stimulus presented to the subject in each test; and
D) using the objective physiologic responses including the reflexive responses and/or voluntary ocular-motor responses of the subject's eyes to the optical target stimulus for at least two distinct categories of tests identified in step B) to diagnose the presence of mild traumatic brain injury or concussion.

### Claim 2 (depends on 1)

The method of diagnosis of mild traumatic brain injury or concussion according to claim 1, further including the step of obtaining pre-trauma objective physiologic responses of the subject based upon each of the visual stimulus presented to the subject, wherein the pre-trauma objective physiologic responses form a baseline for the subject.

### Claim 3 (depends on 2)

The method of diagnosis of mild traumatic brain injury or concussion according to claim 2, wherein the step of using the objective physiologic responses to diagnose the presence of mild traumatic brain injury or concussion includes a determining whether at least two post-trauma objective physiologic responses of the subject from at least two distinct categories of tests identified in step B) differs from the associated pre-trauma objective physiologic response by greater than a preset threshold for that response.

### Claim 4 (depends on 3)

The method of diagnosis of mild traumatic brain injury or concussion according to claim 3, wherein the visual stimulus presented to the subject includes at least one nystagmus test, at least one smooth pursuit test, and at least one optokinetic test; and wherein the step of using the objective physiologic responses of step D) includes using the reflexive responses and/or voluntary ocular-motor responses of the subject's eyes to the optical target stimulus for at least three distinct categories of tests identified in step B) to diagnose the presence of mild traumatic brain injury or concussion.

### Claim 5 (depends on 2)

The method of diagnosis of mild traumatic brain injury or concussion according to claim 2, wherein the visual stimulus presented to the subject includes at least one nystagmus test, at least one smooth pursuit test, and at least one optokinetic test; and wherein the step of using the objective physiologic responses of step D) includes using the reflexive responses and/or voluntary ocular-motor responses of the subject's eyes to the optical target stimulus for at least three distinct categories of tests identified in step B) to diagnose the presence of mild traumatic brain injury or concussion.

### Claim 6 (depends on 1)

The method of diagnosis of mild traumatic brain injury or concussion according to claim 1, wherein the visual stimulus presented to the subject includes at least one smooth pursuit test, at least one nystagmus test, and at least one optokinetic test; and wherein the step of using the objective physiologic responses of step D) includes using the reflexive responses and/or voluntary ocular-motor responses of the subject's eyes to the optical target stimulus for at least three distinct categories of tests identified in step B) to diagnose the presence of mild traumatic brain injury or concussion.

### Claim 7 (depends on 6)

The method of diagnosis of mild traumatic brain injury or concussion according to claim 6, wherein the visual stimulus presented to the subject further includes at least one saccades test; and wherein the step of using the objective physiologic responses of step D) includes using the reflexive responses and/or voluntary ocular-motor responses of the subject's eyes to the optical target stimulus for at least four distinct categories of tests.

### Claim 8 (depends on 1)

The method of diagnosis of mild traumatic brain injury or concussion according to claim 1, wherein the step of using the objective physiologic responses to diagnose the presence of traumatic brain injury includes a determining whether at least three post-trauma objective physiologic responses of the subject differs from an associated objective physiologic response of a normative database of similar subjects by greater than a preset threshold for that response.

### Claim 9

A method of diagnosis of traumatic brain injury comprising the steps of:
A) providing an eye tracking unit coupled to the subject having digital cameras directed to the subjects eyes and providing a visual stimulus generating unit configured to generate a series of visual stimulus for the subject;
B) presenting a plurality of visual stimulus to the subject on the visual stimulus generating unit wherein each visual stimulus provides a target stimulus for a distinct visual based neurologic test, wherein the subject is subjected to a battery of tests including at least three of the following tests i) nystagmus tests, ii) smooth pursuit tests, iii) saccades tests, and iv) optokinetic tests;
C) obtaining objective physiologic response of the subject in the form of reflexive responses and/or voluntary ocular-motor responses of the subject's eyes from the eye tracking unit based upon each of neurologic test associated with each visual stimulus presented to the subject; and
D) using the objective physiologic responses to the neurologic tests including the reflexive responses and/or voluntary ocular-motor responses of the subject's eyes to the optical target stimulus for at least three distinct categories of tests identified in step B) to diagnose the presence of traumatic brain injury.

### Claim 10 (depends on 9)

The method of diagnosis of traumatic brain injury according to claim 9, wherein the visual stimulus presented to the subject includes at least one nystagmus test.

### Claim 11 (depends on 10)

The method of diagnosis of traumatic brain injury according to claim 10, wherein the visual stimulus presented to the subject includes at least one optokinetic test.

### Claim 12 (depends on 11)

The method of diagnosis of traumatic brain injury according to claim 11, wherein the visual stimulus presented to the subject includes at least one smooth pursuit test.

### Claim 13 (depends on 12)

The method of diagnosis of traumatic brain injury according to claim 12, wherein the visual stimulus presented to the subject includes at least one saccades test, and wherein the using the objective physiologic responses to the neurologic tests of step D) includes the reflexive responses and/or voluntary ocular-motor responses of the subject's eyes to the optical target stimulus for at least four distinct categories of tests.

### Claim 14 (depends on 9)

The method of diagnosis of traumatic brain injury according to claim 9, wherein the step of using the objective physiologic responses to diagnose the presence of traumatic brain injury includes a determining whether at least three post-trauma objective physiologic responses of the subject differs from an associated objective physiologic response of a normative database of similar subjects by greater than a preset threshold for that response.

### Claim 15 (depends on 9)

The method of diagnosis of traumatic brain injury according to claim 9, further including the step of obtaining pre-trauma objective physiologic responses of the subject from the head mounted goggle unit based upon each of the visual stimulus presented to the subject, wherein the pre-trauma objective physiologic responses form a baseline for the subject.

### Claim 16 (depends on 15)

The method of diagnosis of traumatic brain injury according to claim 15, wherein the step of using the objective physiologic responses to diagnose the presence of traumatic brain injury includes a determining whether at least three post-trauma objective physiologic responses of the subject differs from the associated pre-trauma objective physiologic response by greater than a preset threshold for that response.

### Claim 17 (depends on 16)

The method of diagnosis of traumatic brain injury according to claim 16, wherein the visual stimulus presented to the subject includes at least one nystagmus test.

### Claim 18 (depends on 17)

The method of diagnosis of traumatic brain injury according to claim 17, wherein the visual stimulus presented to the subject includes at least one optokinetic test.

### Claim 19 (depends on 18)

The method of diagnosis of traumatic brain injury according to claim 18, wherein the visual stimulus presented to the subject includes at least one smooth pursuit test.

### Claim 20

A method of screening for mild traumatic brain injury or concussion comprising the steps of:
providing a visual stimulus generating unit configured to generate a series of visual stimulus for the subject and providing an eye tracking unit to the subject;
Performing a battery of tests on the subject through the head mounted goggle based stimulus generating eye tracking unit, the testing battery including at least one predictive saccade test;
at least one anti-saccade test;
and at least one reaction time test;
Obtaining objective physiologic response of the subject in the form of reflexive responses and/or voluntary ocular-motor responses of the subject's eyes from the eye tracking unit based upon each of the visual stimulus presented to the subject in each test; and
Indicating an increased likelihood of mild traumatic brain injury or concussion based upon abnormal results of the reflexive responses and/or voluntary ocular-motor responses of the subject's eyes in this battery of tests.