Methods and kits for assessing neurological and ophthalmic function and localizing neurological lesions
Inventors
Assignees
New York University NYU • US Department of Veterans Affairs
Publication Number
US-10610165-B2
Publication Date
2020-04-07
Expiration Date
2034-06-17
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Abstract
The invention provides methods and kits for detecting, screening, quantifying or localizing the etiology for reduced or impaired cranial nerve function or conduction; localizing a central nervous system lesion; detecting, diagnosing or screening for increased intracranial pressure, pressure or disruption of central nervous system physiology as seen with concussion; or detecting, diagnosing, monitoring progression of or screening for a disease or condition featuring increased intracranial pressure or concussion by tracking eye movement of the subject.
Core Innovation
The invention provides methods and kits for detecting, screening, quantifying or localizing the etiology for reduced or impaired cranial nerve function or conduction; localizing a central nervous system lesion; detecting, diagnosing or screening for increased intracranial pressure, pressure or disruption of central nervous system physiology as seen with concussion; or detecting, diagnosing, monitoring progression of or screening for a disease or condition featuring increased intracranial pressure or concussion by tracking eye movement of the subject.
The methods involve tracking eye movement of both eyes of the subject, analyzing eye movement data, comparing eye movement of a first eye to that of a second eye, and identifying significant differences to localize, diagnose, assess, or quantitate neurological or ophthalmic deficits.
The problem being solved is the difficulty in assessing neurological function and localizing lesions in conditions featuring elevated intracranial pressure, concussion, or cranial nerve dysfunction. Existing methods rely on subjective physical exams, invasive procedures, or imaging that may not detect subtle or functional deficits. Existing eye tracking requires spatial calibration, which presumes intact ocular motility and cooperation, masking certain deficits and limiting utility in neurologically impaired populations. The invention addresses these limitations by providing uncalibrated, quantitative, objective methods and kits for eye movement tracking to detect and assess neurological impairments swiftly and accurately.
Claims Coverage
The claims contain two independent claims focusing on methods for assessing or diagnosing structural and non-structural traumatic brain injury in a subject based on eye movement tracking and analysis.
Method for assessing or quantitating structural and non-structural traumatic brain injury
A method comprising: tracking eye movement of at least one eye of the subject using a suitable device; analyzing the eye movement via a computer connected to the device; comparing movement of a first eye to a second eye of the subject; and calculating a standard deviation or p value comparing the eye movement to a normal or mean eye movement, thus enabling assessment or quantitation of traumatic brain injury.
Method for diagnosing a disease characterized by structural and non-structural traumatic brain injury
A method comprising: tracking eye movement of at least one eye of the subject using a suitable device; analyzing the eye movement data via a computer; comparing eye movement between the first and second eyes; and calculating a standard deviation or p value against a normal or mean eye movement to diagnostically identify traumatic brain injury conditions.
Method for assessing, quantitating, or diagnosing traumatic brain injury using raw pupil position data
A method comprising: tracking eye movement of at least one eye of the subject; collecting raw x and y cartesian coordinates of pupil position; normalizing those coordinates; and calculating individual metrics including variance, skew, box height, width, area, aspect ratio, and conjugacy metrics as defined in formulae in the claims to assess neurological impairment.
The independent claims focus on methods for eye movement tracking and analysis using uncalibrated raw pupil position data, statistical comparisons, and calculation of specific metrics to assess, quantitate, or diagnose structural and non-structural traumatic brain injury, including concussion and subconcussion.
Stated Advantages
High sensitivity in detecting subclinical ocular motility dysfunction associated with elevated intracranial pressure or concussion.
Noninvasive and rapid assessment method suitable for patients unable to perform spatial calibration or follow commands.
Capability to localize brain lesions by comparing asymmetries in eye movements between eyes.
Usefulness for monitoring progression of neurological diseases or traumatic brain injury over time.
Applicability to diverse patient populations including children, aphasics, minimally conscious individuals, and non-cooperative subjects.
Potential to reduce reliance on invasive intracranial pressure monitoring or frequent CT imaging.
High test-retest reliability across different equipment setups and patient conditions.
Documented Applications
Detecting, screening, diagnosing, quantitating, or localizing reduced or impaired cranial nerve function or conduction (cranial nerves II, III, IV, VI).
Localizing central nervous system lesions featuring increased intracranial pressure from trauma, cerebrovascular accident, aneurysm, tumors, infectious or inflammatory diseases, hydrocephalus, pseudotumor, neurodegenerative diseases, or idiopathic causes.
Detecting, diagnosing, monitoring progression of, or screening for increased intracranial pressure in various conditions.
Detecting, diagnosing, or screening for concussion and subconcussion brain injuries including blast injury.
Detecting or diagnosing transtentorial herniation and normal pressure hydrocephalus, including shunt malfunction and valve pressure optimization.
Assessing or quantitating conjugacy or disconjugacy of eye movement (strabismus), including diseases characterized by disconjugate gaze from neurological or ophthalmologic causes.
Monitoring progression of neurological diseases affecting ocular motility or cranial nerve function.
Quantitatively assessing cognitive integrity and overall central nervous system functional integrity.
Use in portable or stationary eye movement tracking kits with computer programs for data analysis.
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