Neurocognitive function EEG measurement method and system
First Claim
1. The method of measuring changes in a human subject'"'"'s fundamental cognitive brain functions, the changes, for example, being due to disease, injury, remedial treatment, the utilization of medicines and normal variation within and between days and over a period of time, including the steps of:
- (a) presenting an attention-damanding task to the subject, which engages one or more of the subject'"'"'s fundamental cognitive functions, and, simultaneously;
(b) at least once, measuring the subject'"'"'s behavioral responses to the task, and neuroelectric activity at the subject'"'"'s scalp using a set of electroencephalograph (EEG) electrodes and amplifier and analog/digital converters, to provide a set of baseline digital data representing the subject'"'"'s baseline state behavioral responses and neuroelectric activity response to the task;
(c) at least once again, measuring the subject'"'"'s behavioral responses to the task, and neuroelectric activity at the subject'"'"'s scalp using a set of electroencephalograph (EEG) electrodes and amplifier and analog/digital converters, to provide a set of possibly altered state digital data representing the subject'"'"'s possibly altered state behavioral responses and neuroelectric activity in response to the task;
(d) in a computer system, comparing the subject'"'"'s baseline state and possibly altered state digital data using a mathematical function derived from behavioral responses and EEG derived neuroelectric activity responses of a reference group of subjects performing the same task recorded in their baseline and altered state conditions, the comparison using a multivariate statistical method combining measures of task performance with brain function measures in a single comparison, and (e) deriving one or more scores for the subject based on the comparison described in (d) and determining the significance of those scores.
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Abstract
An efficient, objective testing method and system for evaluating changes in mental function is described. The method and system are based on measuring an individual'"'"'s behavioral responses and brain function during a brief cognitive test battery and passive control conditions. The method and system is designed to assess an individual'"'"'s fundamental cognitive functions, and whether those functions have been significantly affected by a variety of factors such as progressive disease processes, medication, stress, fatigue, training, or the passage of time. The method and system can be used to determine whether drugs being evaluated to treat diseases or conditions affecting cognitive brain function have a significant positive effect on delaying or improving the symptoms of such a disease or condition, especially during clinical trials for drug approval and subsequent marketing. The method and system may also be employed as part of the successful diagnosis or ongoing treatment of neurological diseases or conditions that directly or indirectly affect human neurocognitive performance. The method and system may also be used to determine transitory changes in overall cognitive function due to emotional stress or fatigue, and more long lasting changes in overall cognitive function following training and educational programs.
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Citations
27 Claims
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1. The method of measuring changes in a human subject'"'"'s fundamental cognitive brain functions, the changes, for example, being due to disease, injury, remedial treatment, the utilization of medicines and normal variation within and between days and over a period of time, including the steps of:
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(a) presenting an attention-damanding task to the subject, which engages one or more of the subject'"'"'s fundamental cognitive functions, and, simultaneously;
(b) at least once, measuring the subject'"'"'s behavioral responses to the task, and neuroelectric activity at the subject'"'"'s scalp using a set of electroencephalograph (EEG) electrodes and amplifier and analog/digital converters, to provide a set of baseline digital data representing the subject'"'"'s baseline state behavioral responses and neuroelectric activity response to the task;
(c) at least once again, measuring the subject'"'"'s behavioral responses to the task, and neuroelectric activity at the subject'"'"'s scalp using a set of electroencephalograph (EEG) electrodes and amplifier and analog/digital converters, to provide a set of possibly altered state digital data representing the subject'"'"'s possibly altered state behavioral responses and neuroelectric activity in response to the task;
(d) in a computer system, comparing the subject'"'"'s baseline state and possibly altered state digital data using a mathematical function derived from behavioral responses and EEG derived neuroelectric activity responses of a reference group of subjects performing the same task recorded in their baseline and altered state conditions, the comparison using a multivariate statistical method combining measures of task performance with brain function measures in a single comparison, and (e) deriving one or more scores for the subject based on the comparison described in (d) and determining the significance of those scores. - View Dependent Claims (6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27)
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2. The method of measuring changes in a human subject'"'"'s fundamental cognitive brain functions, the changes, for example, being due to disease, injury, remedial treatment, the testing of medicines and normal variation within and between days and over a period of time, including the steps of:
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(a) presenting an attention-demanding task to the subject, which engages the subject'"'"'s fundamental cognitive functions, and, simultaneously;
(b) at least once, measuring the subject'"'"'s behavioral responses to the task, and associated brain function using functional magnetic resonance imaging (fMRI), alone or in combination with EEG, to provide a set of baseline digital data representing the subject'"'"'s behavioral responses and brain activity in response to the task;
(c) at least once again, measuring the subject'"'"'s behavioral responses to the task, and associated brain function using functional magnetic imaging (fMRI), alone or in combination with EEG, to provide a set of possibly altered state digital data representing the subject'"'"'s behavioral responses and brain activity in response to the task;
(d) in a computer system, comparing the subject'"'"'s baseline state and possibly altered state digital data using a mathematical function derived from the behavioral responses and fMRI derived brain activity responses, alone or in combination with EEG derived neuroelectric activity responses, of a reference group of subjects performing the same task recorded in their baseline and altered state conditions, the comparison using a multivariate statistical method to combine the measures of task performance with brain function measures in a single comparison; and
(e) deriving one or more scores for the subject based on the comparison described in (d) and determining the significance of those scores.
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3. The method of measuring change in a human subject'"'"'s fundamental cognitive brain functions, the changes, for example, being due to disease, injury, remedial treatment, the testing of medicines and normal variation within and between days and over a period of time, including the steps of:
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(a) presenting an attention-demanding task to the subject, which engages the subject'"'"'s fundamental cognitive functions, and, simultaneously;
(b) at least once, measuring the subject'"'"'s behavioral responses to the task, and associated brain function using magnetoencephalograms (MEG), alone or in combination with EEG, to provide a set of baseline digital data representing the subject'"'"'s behavioral responses and brain activity in response to the task;
(c) at least once again, measuring the subject'"'"'s behavioral responses to the task, and associated brain function using magnetoencephalograms (MEG), alone or in combination with EEG, to provide a set of possibly altered state digital data representing the subject'"'"'s behavioral responses and brain activity in response to the task;
(d) in a computer system, comparing the subject'"'"'s baseline state and possibly altered state digital data to derive an overall score using a mathematical function derived from the behavioral responses and MEG derived brain activity responses, alone or in combination with EEG derived neuroelectric activity responses, of a reference group of subjects performing the same task recorded in their baseline and altered state conditions, the comparison using the multivariate statistical method to combine measures of task performance with the brain function measures in a single comparison; and
(e) deriving one or more scores for the subject based on the comparison described in (d) and determining the significance of those scores.
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4. The method of measuring changes in a human subject'"'"'s fundamental cognitive brain functions, the changes, for example, being due to disease, injury, remedial treatment, the testing of medicines and normal variation within and between days and over a period of time, including the steps of:
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(a) presenting an attention-demanding task to the subject, which engages the subject'"'"'s fundamental cognitive functions, and, simultaneously;
(b) at least once, measuring the subject'"'"'s behavioral responses to the task, and neuroelectric activity at the subject'"'"'s scalp using a set of electroencephalograph (EEG) electrodes and amplifier and analog/digital converters, to provide a set of baseline digital data representing the subject'"'"'s behavioral responses and neuroelectric activity in response to the task;
(c) at least once again, measuring the subject'"'"'s behavioral responses to the task, and neuroelectric activity at the subject'"'"'s scalp using a set of electroencephalograph (EEG) electrodes and amplifier and analog/digital converters, to provide a set of possibly altered state digital data representing the subject'"'"'s behavioral responses and neuroelectric activity in response to the task;
(d) in a computer system, comparing the subject'"'"'s baseline state and possibly altered state digital data to behavioral responses and EEG derived neuroelectric activity responses of a reference group of subjects performing the same task recorded in their baseline and altered states, the comparison using a multivariate statistical method combining measures of task performance with brain function measures in a single comparison, and (e) deriving a score for the subject based on the comparison of (d) and determining the significance of the score.
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5. The method of measuring changes in a human subject'"'"'s fundamental cognitive brain functions, the changes, for example, being due to disease, injury, remedial treatment, the testing of medicines and normal variation within and between days and over a period of time, including the steps of:
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(a) presenting an attention-demanding task to the subject, which engages one or more of the subject'"'"'s fundamental cognitive functions, and, simultaneously;
(b) at least once, measuring the subject'"'"'s behavioral responses to the task, and neuroelectric activity at the subject'"'"'s scalp using a set of electroencephalograph (EEG) electrodes and amplifier and analog/digital converters, to provide a set of baseline digital data representing the subject'"'"'s baseline state behavioral responses and neuroelectric activity in response to the task;
(c) at least once again, measuring the subject'"'"'s behavioral responses to the task, and neuroelectric activity at the subject'"'"'s scalp using a set of electroencephalograph (EEG) electrodes and amplifier and analog/digital converters, to provide a set of possibly altered state digital data representing the subject'"'"'s possibly altered state behavioral responses and neuroelectric activity in response to the task;
(d) computing measures from the baseline and possibly altered state sets of digital data and grouping the measures into one or more classes, called for example, Behavioral Performance, Neurophysiological Cognitive and Neurophysiological Alertness; and
applying rules, based on expert neuropsychological and neurophysiological knowledge, to each of the measures within each of the classes to determine if the measures differ in an expected manner between each subject'"'"'s baseline and subsequent, possibly altered, states;
(e) in a computer system, comparing the subject'"'"'s data analyzed as in (d) to identically analyzed data of a reference group of subjects performing the same task recorded in their baseline and altered state conditions, the comparison using a multivariate statistical method combining measures of task performance with brain function measures in a single comparison; and
(f) deriving a score for the subject based on the comparison of (e) and determining the significance of the score.
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Specification