Methods and kits for assessing central nervous system integrity
Inventors
Samadani, Uzma • Offen, Shani • Carrasco-Queijeiro, Marisa • Heeger, David
Assignees
New York University NYU • US Department of Veterans Affairs
Publication Number
US-10219694-B2
Publication Date
2019-03-05
Expiration Date
2033-03-25
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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 or associated cranial nucleus or supranuclear input, useful for detecting, diagnosing or screening for increased intracranial pressure, or useful for detecting, diagnosing, monitoring progression of or screening for a disease or condition featuring increased intracranial pressure by tracking eye movement of the subject. The methods may be performed by a) analyzing eye movement of the subject; b) comparing eye movement of the subject to eye movement of a control or the subject's own baseline eye movement; and c) identifying the subject as having eye movement significantly different from the control or the subject's own baseline eye movement.
Core Innovation
The invention provides novel methods and kits for detecting, screening, quantifying, or localizing reduced or impaired cranial nerve function or conduction, and associated cranial nucleus or supranuclear input. These methods are useful for detecting, diagnosing, or screening for increased intracranial pressure (ICP) and for monitoring diseases or conditions featuring elevated ICP by tracking eye movement of the subject. The approach involves analyzing eye movement, comparing it to control or baseline eye movement, and identifying significant differences indicating abnormality.
The invention addresses the problem that current methods for assessing elevated intracranial pressure rely on history, physical exam, radiographic imaging, and invasive direct pressure measurements, which can be unpleasant, insensitive, or risky. Papilledema, a conventional marker for elevated ICP, is often insensitive and subjective. Automated eye tracking has been limited by the need for calibration requiring intact ocular motility and cooperation, which is challenging in neurologically impaired patients. The present invention circumvents these limitations by providing uncalibrated eye movement tracking methods that can detect subclinical ocular motility dysfunction related to cranial nerve impairment and elevated ICP.
By tracking eye movements in response to a moving visual stimulus, the invention generates high-resolution data assessing ocular motility reflective of cranial nerve function (II, III, IV, VI) and supranuclear control. The invention enables quantitative evaluation of eye movement trajectories, represented as normalized scatterplots resembling box figures corresponding to stimulus motion. Variations or distortions in these trajectories correlate with specific cranial nerve dysfunction or mass effect from intracranial lesions. Statistical comparisons to control distributions or the subject's own baseline permit sensitive detection of neurological impairment, including subtle or subclinical cranial nerve palsies and elevated intracranial pressure.
Claims Coverage
The claims include two independent claim groups focused on methods for assessing central nervous system integrity and for detecting or monitoring diseases featuring increased intracranial pressure.
Uncalibrated eye movement tracking for assessing central nervous system integrity
A method comprising tracking eye movement of a subject without prior spatial calibration, analyzing eye movement data, comparing it to a control or subject's baseline, and identifying significant differences by generating and plotting pairs of (x,y) values representing horizontal and vertical instantaneous pupil reflection angles over time.
Detection and monitoring of diseases featuring increased intracranial pressure by eye movement analysis
A method comprising tracking eye movement of a subject, analyzing and comparing it to control or baseline eye movement, and identifying significant differences indicative of disease or conditions featuring increased intracranial pressure such as trauma, cerebrovascular accident, aneurysm, vascular lesion, tumor, infectious or inflammatory processes, disruption of venous drainage, pseudotumor, hydrocephalus, or idiopathic causes.
The inventive features focus on non-spatially calibrated eye movement tracking and analysis using pupil reflection angles to detect cranial nerve function abnormalities and diagnose or monitor intracranial pressure-related diseases by comparing subject eye movements to controls or baselines.
Stated Advantages
High sensitivity in detecting subclinical ocular motility dysfunction related to elevated intracranial pressure and cranial nerve impairment.
Noninvasive and rapid assessment without the need for spatial calibration or complex patient cooperation.
Reduction in the need for invasive pressure monitoring and radiographic imaging, potentially minimizing radiation exposure and sedation risks.
Capability to localize intracranial lesions and monitor progression or recovery over time quantitatively.
Applicability to varied patient populations including those with impaired consciousness or neurological deficits who cannot perform traditional eye-tracking calibration.
Documented Applications
Detecting, diagnosing, monitoring progression, and screening for increased intracranial pressure from various causes including trauma, stroke, aneurysm, tumor, infectious and inflammatory diseases, and hydrocephalus.
Assessing cranial nerve function impairment specifically for cranial nerves II, III, IV, and VI and associated nuclei.
Quantifying severity of normal pressure hydrocephalus, detecting shunt malfunction, and optimizing valve pressure in treatment.
Detecting transtentorial herniation as manifested by cranial nerve III palsy.
Detecting or evaluating posterior fossa mass effect manifested by cranial nerve VI palsy.
Detecting, screening for, or diagnosing disorders impeding conductance through the optic disc or optic nerve.
Using a computer system and kits incorporating eye tracking devices and software algorithms for data analysis and clinical interpretation.
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