Abstract:
A computerized system designed as a professional tool to administer psychological and neuropsychological tests to human subjects using multimedia technology to present and collect audiovisual and graphomotor response data, and continuously accumulate normative and clinical data in a centralized database that is remotely accessible via the internet. A set of integrated hardware and software components utilize the internet for data transfer and access. Local testing modules administer tests to subjects with minimal examiner involvement, use audiovisual test presentation, and collect response data that includes audiovisual, graphic and touch responses. The local testing modules are remotely connected to a centralized data bank that stores and accumulates subject data, and can be remotely accessible for clinical comparison of individual subjects for diagnostic purposes, or for group analyses for research purposes. Test administration and database software are a part of the system. The system is expandable to incorporate additional local test software. Available technology is integrated to improve the testing methodology, data collection, assessment throughput, normative data availability, normative and clinical database expandability, and potential for diverse and creative data analysis.

Description:
[0001]     This application claims priority from U.S. provisional application Ser. No. 60/729,564 filed on Oct. 24, 2005, which is incorporated herein by reference, in its entirety. 
     
    
     BACKGROUND OF THE INVENTION  
       [0002]     1. Field of the Invention  
         [0003]     This invention relates to the field of Clinical Neuropsychology and Neuropsychological Assessment. Clinical Neuropsychology is an applied science concerned with the behavioral expression of brain function and dysfunction (Lezak, 1995). Neuropsychological assessment involves administration of standardized tests of various cognitive functions and emotional status to help elucidate and quantify behavioral changes that may have resulted from central nervous system disease. The present invention relates to apparatus, methods, etc. in which a computerized system administers psychological and neuropsychological tests to human subjects in a highly standardized, yet intuitive manner, requires minimal examiner involvement, accumulates data from multiple testing locations, and permits remote access to the data for clinical and research purposes.  
         [0004]     2. Background Art  
         [0005]     There are multiple neuropsychological assessment tools, including the prevalent traditional paper and pencil tests (Lezak, 1995; Spreen and Strauss, 1998), as well as computerized and internet-based tests (Butcher, Perry, and Hahn, 2004; Anger, 2003; Letz, 2003; Kane and Kay, 1992). Despite the breadth in variety of the developed testing tools significant limitations in testing efficiency, throughout, and data collection restrain scientific advancement.  
         [0000]     Limitations of Traditional Instruments Prevalent in Neuropsychological Assessment  
         [0006]     The most commonly used procedures currently implemented in neuropsychological assessment are paper and pencil tests. These share four basic limitations which significantly restrict the throughput of neuropsychological assessment procedures, including: 1) individual test administration; 2) inefficient data collection and sharing; 3) narrow amount of information obtained from test administration, and 4) variability in the way the tests are administered.  
         [0007]     1) Low throughput due to individual test administration. Most of the currently used neuropsychological tests are designed for individual administration, making the testing procedures inefficient and time consuming. According to Sweet, Peck, Abramowitz, and Etzweiler (2002) test administration takes on the average 4.92 hours (SD=2.24) with an additional 1.2 hours needed for scoring (SD=0.78). In fact, test administration is the component of neuropsychological assessment requiring the largest amount of time. Those tests that do not require individual administration still require time for scoring. Quite a number of neuropsychologists, working in various settings use testing assistants to improve their throughput. Abovementioned authors found that among their sample of 1,352 respondents 51.2% indicated that they use testing assistants when conducting neuropsychological evaluations. Interestingly, use of testing assistants was associated with a greater number of testing hours. While use of testing assistants permits a single professional to evaluate more people, throughput is still quite limited by individual test administration.  
         [0008]     2) Inefficient data collection, sharing, and integration. Normative and clinical data are crucial as they provide the basis of comparison for test results. The normative and clinical data available with the majority of neuropsychological instruments is limited due to inefficiencies and expense of data collection sharing, and integration.  
         [0009]     Mitrushina, Boone and D&#39;Elia in their Handbook of Normative Data for Neuropsychological Assessment (1999) state, “. . . although neuropsychological assessment procedures are widely available, there is a relative scarcity of normative data for most tests.” (p. 6). This scarcity relates to the expense and labor intensity of data collection which in turn relates to the low throughput of current data collection techniques. Typically, the normative data are collected prior to test publication and are supplied with the printed test manual. Additional research on the test is reported in professional publications. There is no readily available method for augmenting the original norms with the new research data.  
         [0010]     For a number of neuropsychological tests normative data are available from different sources and populations. It falls upon a clinician to select the most appropriate normative group from the available sources, none of which may be ideal. According to Mitrushina et al. (1999), “A frequent difficulty one encounters is that use of one set of norms may suggest that the patient is performing in the impaired range while use of another normative sample may suggest that performance is within normal limits.” (p.6). Meta-analysis technique has been used to integrate information from various studies. However, such research is limited by a small number of commonly reported variables, as well as by the amount of effort involved in finding and organizing such information. There is no currently available method that allows sharing of data between studies in order to select a particular demographic or clinical group for clinical comparison.  
         [0011]     Test performance in a population can change over time. Uttl and Van Alstine (2003) found that Vocabulary subtest scores of the Wechsler Adult Intelligence Scale (Wechsler, 1955; Wechsler, 1981; Wechsler, 1997a) have been rising over the past decades. At this time, a normal older adult (˜65 years old) with average intelligence is expected to receive a score equivalent to 124 IQ points (Superior range) on the WAIS Vocabulary test (normed between 1953 and 1954), and 112 IQ points (High Average range) on the WAIS-R (Wechsler, 1981) Vocabulary test (normed between 1976 and 1980). These findings suggest that systematic norm updates are necessary for accurate assessment of levels of functioning. However, current tools make these updates very laborious, expensive, and limited in scope.  
         [0012]     Tests with the best normative samples provide data for over a thousand individuals with demographic characteristics comparable to that described in the recent US Census. Subdividing or stratifying the sample according to demographic characteristics such as age and education is desirable as it allows comparison of a subject&#39;s performance to that of his or her peers. Therefore, any score deviation is more likely to be due to some sort of abnormality rather than to testing/sampling artifact. While the total sample size may be impressive, stratification for even one or two demographic variables results in small representations within the individual cells. The Wechsler Memory Scale-Third Edition (WMS-III; 1997b) was co-developed with the WAIS-III, and was standardized on a sample of 1,250 adults divided into 13 age groups. The standardization sample is representative of the US in regard to gender, ethnicity, educational level, and geographic region. However, for individual normative comparison only age stratification is available. With age stratification the numbers of individuals in each of the age groups is between 75 and 100.  
         [0013]     Clinical group comparison can help with diagnostic attribution of abnormal findings. The WAIS-III, WMS-III Technical Manual provides information on several clinical groups including Alzheimer&#39;s, Huntington&#39;s, Parkinson&#39;s Diseases, Traumatic Brain Injury, etc. However, the sample sizes for each of the disorders are small: 35, 15, 10, and 22 cases, respectively. No age stratification is provided for the clinical samples.  
         [0014]     In order to stratify data along several parameters and have representative numbers of observations in each of the cells large numbers of individuals need to be tested. Performance of various clinical groups with different types of pathology is important to have for clinical comparison and differential diagnosis. Demographic stratification of clinical data is important for the same reasons as normative data. Systematic normative and clinical data updates are important to keep up with changes in test performance in the population. The efficiency, sharing, and integration limitations in the current testing methods do not permit such data collection.  
         [0015]     3) Narrow amount of information obtained from test administration. The amount of information collected during test administration is rather narrow. Potentially useful information is irretrievably lost with current testing methods. Test data obtained from the traditional paper and pencil tests consists of the examiner&#39;s written record of the subject&#39;s responses, the time it took the subject to complete a particular task, the writing or drawing that the subject produced, and some behavioral observations (in the form of written notes or examiner&#39;s memory of what the subject did).  
         [0016]     For example, the test protocol for the Rey-Osterrieth Complex Figure Test (Rey, 1941; Osterrieth, 1944) consists of the drawings made by the subject and the time it took to complete the task. Depending on the mode of administration, the drawing may be completed with different color pencils with a record of color sequence, to aid in assessment of the constructional strategy. Alternately, there may be an accompanying drawing completed by the examiner containing the sequence of the subject&#39;s construction. There may be notes on the subject&#39;s behavior during test administration.  
         [0017]     Much of the potentially useful information such as the latency of the response, direction of gaze, style of pencil grip, time spent examining the stimulus, facial expression during task performance, representation of the actual motor activity, verbalizations, etc. are lost. No matter how conscientious the examiner, how good are his or her memory capacities and how careful he or she is at taking written notes, some of the information will be omitted. Having a more complete record of the subject&#39;s behavior during testing, especially if collected in an objective and standardized fashion will greatly enhance the clinical and research utility of psychological and neuropsychological testing. The importance of such information is uncertain. However, the irretrievable loss of this information prohibits future systematic examination of variables that may be of interest.  
         [0018]     4) Variability in test administration. Despite efforts to standardize test administration current methods allow substantial variability in these procedures that is a potential source of error. Reliability and stability coefficients of our commonly used measures, while decent, are far from ideal even for well-standardized tests. It is considered desirable for reliability coefficients to be at 0.80 or above. The WAIS-III/WMS-III Technical manual (Wechsler, 1997c) provides tables of reliability coefficients for these tests. For WAIS-III all IQ and Index score reliabilities are 0.86 or above. However, for the subtests (14 separate tasks comprising the WAIS-III), 50 of the 182 (or 27%) of the reliability coefficients fall below 0.80 (range of low coefficients being 0.50 to 0.79). For the WMS-III the proportion of correlation coefficients below 0.80 is even higher: 18 of 104 (or 17%) Index scores, and 70 out of 143 (or 49%) subtest scores (range 0.64 to 0.79). Test-retest stability for the WAIS-III was described in the Technical Manual as “adequate” (p.57). The same descriptor is not provided for the WMS-III stabilities. For the WAIS-III subtests, 29 of 56 (or 52%) reported uncorrected stability coefficients are below 0.80, and 10 out of 56 (or 18%) are below 0.70. For the WMS-III subtests, 21 out of 22 (or 95%) of the uncorrected stability coefficients fall below 0.80, and 10 of the 22 (or 45%) fall below 0.70.  
         [0019]     Test manuals usually focus attention on the importance of following the testing procedures with minimal deviations. Some test batteries, like the Halstead-Reitan Neuropsychological Test Battery (Reitan and Wolfson, 1985), even ask that the examiner learn the test instructions verbatim. However, there are invariable differences in which test procedures are administered. These differences may be very subtle, relating to the speed of presentation of instructions, breaks in phrasing, voice quality, or voice intonation and modulation, direction of the examiner&#39;s gaze at the materials, frequency and appropriateness of eye contact, etc. Other factors may include subtle changes in verbal instructions, familiarity and facility in the manipulation of test materials. This is aside from the procedures to “test limits” by allowing additional time for task completion or providing cues. Variation on the procedures may or may not be specifically addressed in the test administration instructions, but data are not typically provided as to the effects of such altered test administration.  
         [0020]     Additional differences during test administration include examiner&#39;s appearance, gender, and ethno-cultural background. Even factors such as height, hair color, and attire introduce additional variation. There may be the divergent influence of interpersonal factors relating to the quality of rapport between the examiner and the subject. It is not entirely clear how these factors influence test performance individually or in combination. Information regarding the amount of error present in measurements is described in studies such as those summarized above for the WAIS-III and WMS-III. Relatively little is known about the sources of error for the majority of tests. However, it is quite possible and even likely that in assessment of subtle psychological phenomena, variations in test administration can introduce noise artifacts that may obscure or even overwhelm the phenomenon of interest. Eliminating such sources of error is likely to enhance the utility of neuropsychological procedures.  
         [0000]     Limitations of Currently Used Computerized Tests  
         [0021]     Computerized psychological and neuropsychological tests in current use provide partial solutions to the problems discussed above, yet still suffer many of the limitations of the traditional tests. Overall, test administration is more firmly standard, detailed timing parameters are collected, and scoring accuracy is improved. The limitations remain with regard to low throughput due to individual administration, inefficient data collection and sharing, and narrow range of collected data. Tests are developed in a form of software and there is variability in test administration that relates to the specific equipment that is used and the testing environment. Many currently available computer tests have an additional limitation related to the interface between the subject and the computer. The newer test batteries utilize some of the recent technological innovations, but none make wide-ranging use of current technology to integrate multimedia presentation, intuitive interface, collection of comprehensive audio-visual and graphomotor behavioral data, speech and pattern recognition technology, centralized [expandable] data base, and internet data access and sharing.  
         [0022]     A number of the frequently used computerized psychological and neuropsychological tests such as the Conners&#39; CPT-II (Conners and MHS Staff, 2002), and the computer administered Wisconsin Card Sorting Test (WCST: Heaton, Chelune, Talley, Kay, and Curtiss, 1993; Heaton and PAR Staff, 1999) use individual administration, examiner instruction or online written instructions, and keyboard entry of responses. The tests are distributed as software, results are stored on a local PC and are not centrally compiled or shared. Similar limitations are found among the specially developed neuropsychological test batteries such as the ANAM (Kabat, Kane, Jefferson and DiPino, 2001), and COGSCREEN (Kay, 1995). These tests are administered with written online instructions, keyboard or mouse entry of responses and local data storage. The range of recorded responses is limited to the key or mouse entries and timing.  
         [0023]     Internet based tests such as the Concussion Resolution Index (CRI; Erlanger, Feldman, Kutner, Kaushik, Kroger, Festa, Barth, Freeman, and Broshek, 2003) is administered with limited examiner involvement and allows remote access for testing and data analysis. While this type of testing permits centralized data accumulation, the system is limited by the interface with written instructions, keyboard responses, no audiovisual recording or drawing responses.  
         [0024]     Several computer-administered test batteries partially utilize recent technological innovations. The Cambridge Neuropsychological Test Automated Battery (CANTAB; Robins, James, Owen, Sahakian, McInnes, and Rabbitt, 1994; Robins, James, Owen, Sahakian, Lawrence, McInnes, and Rabbitt, 1998) utilizes a touch screen monitor for data acquisition. However, the test is individually administered with instructions provided verbally by an examiner who remains with the subject through the testing session. The amount of behavioral information recorded is narrow and there is no central compilation of the data.  
         [0025]     Three test batteries use recorded voice instruction, minimal examiner involvement, and conditional responsiveness to subject&#39;s keyboard strokes (Aharonson and Korczyn, 2004; BARS; Rohlman, Gimenes, Eckerman, Kang, Farahat, and Anger, 2003; and NES3: Letz, Green, and Woodard, 1996; Letz, GiIorio, Shafer, Yeager, Schomer, and Henry, 2003). None of these batteries collect audiovisual data, use speech recognition technology, or allow central database compilation, provide an expandable database or remote access to the results.  
       SUMMARY OF THE INVENTION  
       [0026]     This invention, the Neuropsychological Assessment Platform (NPAP), is a computerized system designed as a professional tool to administer psychological and neuropsychological tests to human subjects, collect and accumulate data from various locations and to make that data widely available for clinical and research purposes. NPAP contains integrated hardware and software components and utilizes the internet for data transfer and access. The system includes local testing modules that administer tests to subjects with minimal examiner involvement, use audiovisual test presentation, collect response data that includes audiovisual, graphic and touch responses. The local testing modules are remotely connected to a centralized data bank that stores and accumulates subject data, and can be remotely accessible for clinical comparison of individual subjects for diagnostic purposes, or for group analyses for research purposes. The system includes test and database software and is designed to permit addition of new test software and software updates. This computerized testing system integrates the latest currently available technology to improve the testing methodology, data collection, assessment throughput, normative data availability, normative and clinical database expandability, and potential for diverse and creative data analysis.  
         [0027]     The invention is also directed to a method of performing such testing and/or assessment.  
         [0028]     It is an object of the invention to provide a superior tool for efficient and accurate neuropsychological data collection, analysis and distribution by integration of the latest technological advances such as multimedia presentation, touch screen, audiovisual recording and internet connectivity.  
         [0029]     It is a further object of the invention to provide for administration of a battery of neuropsychological tests covering the important domains including attention, memory, language, visuospatial/constructional, executive, and emotional/personality functions, with tests designed to minimize cultural bias.  
         [0030]     It is another object of the invention to provide administration of tests using a multimedia audiovisual format with minimal examiner involvement.  
         [0031]     It is another object of the invention to provide collection of comprehensive behavioral response data that will include video, audio, drawing, eye gaze, and pointing responses.  
         [0032]     It is another object of the invention to provide an automated reaction to the subject&#39;s responses with instructions and cues.  
         [0033]     It is another object of the invention to permit testing of subjects with no computer experience, typing ability, limited education, and cognitive difficulties.  
         [0034]     It is another object of the invention to permit testing of several individuals simultaneously.  
         [0035]     It is another object of the invention to provide an avenue for addition of new tests, test updates, and updates of data analysis software.  
         [0036]     It is another object of the invention to provide for accumulation of data in a centralized location that will be remotely accessible via the internet.  
         [0037]     It is another object of the invention to provide a system comprising the locally connected subject&#39;s station and the examiner&#39;s station, as well as the remotely accessible central data bank.  
         [0038]     These objects and others are achieved in accordance with the invention by integrating the available electronic and data transmission components with original software into a versatile and expandable system that functions as a professional tool. 
     
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       [0039]     The foregoing aspects and other features of the present invention are explained in the following description, taken in connection with the accompanying drawings, wherein:  
         [0040]      FIG. 1  is a block diagram of the NPAP apparatus components and connectivity.  
         [0041]      FIG. 2  is a diagram of the components of the Subject&#39;s Station of  FIG. 1  from the Subject&#39;s perspective.  
         [0042]      FIG. 3  is a plan view diagram of the components of the Subject&#39;s Station depicted in  FIG. 1  and  FIG. 2 . if viewed from above.  
         [0043]      FIG. 3A  is a side view of portions of the arrangement of  FIG. 3 .  
         [0044]      FIG. 4  is a diagram of the components of the Examiner&#39;s Station depicted in  FIG. 1  from the examiner&#39;s view. 
     
    
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT  
       [0045]     It should be understood that the foregoing description is only illustrative of the invention. Various alternatives and modifications can be devised by those skilled in the art without departing from the invention. Accordingly, the present invention is intended to embrace all such alternatives, modifications and variances which fall within the scope of the appended claims.  
         [0046]     Referring to  FIG. 1 ,  FIG. 2 ,  FIG. 3 , and  FIG. 4  there is shown a diagrammatic view of the NPAP apparatus incorporating features of the present invention. Although the present invention will be described with reference to the single embodiment shown in the drawings, it should be understood that the present invention can be embodied in many alternate forms of embodiments. In addition, any suitable size, shape or type of elements or materials could be used.  
         [0047]      FIG. 1  is a block diagram of the apparatus components and connectivity. The Local Testing Module  10  represents the portion of the computerized apparatus that is located at a testing facility where subjects are physically present and examined. The Local Testing Module consists of one or more Subject&#39;s Stations  12  connected by a local network to an Examiner&#39;s Station  14 . The Subject&#39;s Station  12  is equipped to present the tests and to record data. The Examiner&#39;s Station  14  controls one or more Subject&#39;s Stations  12  and is equipped to start, stop, and monitor testing. Once testing is completed the data from the Local Testing Module  10  is forwarded to a Central Data Bank  16  via a remote secure internet connection  18 . The Central Data Bank  16  can receive input from multiple Local Testing Modules  10 . The Central Data Bank  16  performs two principal activities. First, it accumulates and permanently stores test data. Second, it provides an interface to perform queries on the stored data. The Central Data Bank  16  is accessible by multiple Remote Access Stations  20  via secure remote internet connections  22  for examination and analysis of the stored data.  
         [0048]      FIG. 2  is a diagram of the components of the Subject&#39;s Station  12  of  FIG. 1  from the Subject&#39;s perspective. The Subject&#39;s Station  12  is designed around a custom multimedia computer  24  that is used to administer the tests to the subject. Various components illustrated in  FIG. 2  are connected to computer  24  by wire or wireless links (not shown) in a manner well known in the art. The Subject&#39;s Station  12  contains a high resolution touch screen  26  allowing simple pointing responses without the need for a keyboard. An additional tablet monitor  28 , having a stylus  30  is included to allow drawing or written responses. Responses by touch or stylus will also be archived. Two pan/tilt controllable camera units  32   a  and  32   b  are a part of the station, providing video of the subject, with the capability of tracking certain features on the subject. Additionally, an eye-tracking system  34 , as offered by or similar to the Eyegaze Analysis System, manufactured by LC Technologies, Inc. of Fairfax, Va., U.S.A. is a part of the station to follow gaze response and relate it to the test responses. Microphones  36   a  and  36   b  are used to record verbal responses. A light source  38  provides standard illumination for video recording. An audio system, implemented by using computer  24  and having speakers  40   a  and  40   b , provides high quality auditory stimuli. A Panic Button  42  is included to allow the subject to call the examiner for assistance. All measured inputs are globally timed and synchronized. In this way, an accurate record of the subject&#39;s total response during the test can be archived and the session recreated. All of the responses and sensory input are automatically sent to the Central Data Bank  16  via the examiner&#39;s station  14  to create the global database of test responses.  
         [0049]      FIG. 3  is a diagram of the components of the Subject&#39;s Station depicted in  FIG. 1  and  FIG. 2 , if viewed from above.  
         [0050]     In  FIG. 3A , the touch screen monitor is depicted in a tilted position to enhance touch responses. A subject&#39;s chair  44  indicates the subject&#39;s position relative to the system components.  
         [0051]      FIG. 4  is a diagram of the components of the Examiner&#39;s Station  14  depicted in  FIG. 1  from the examiner&#39;s view. Station  14  is designed around a computer  56 . Various components illustrated in  FIG. 4  are connected to computer  56  by wire or wireless links (not shown) in a manner well known in the art. The components include a conventional keyboard  46  and mouse  48 , a microphone  50  and speakers  52   a  and  52   b . With assistance from observations made on video monitor  54 , station  14  is used to control multiple subject&#39;s stations  12 .  
         [0052]     By using multiplexing, a single examiner can monitor a number of subject consoles. Station  14  has the capability of multiple video and audio feeds from each of the Subject&#39;s stations  12 , allowing the examiner to monitor a subject individually. Examiner&#39;s Station  14  has the capability of remote intervention during the test. Monitor  54  displays the test administration information from each of the locally connected Subject&#39;s Stations  14 .  
         [0053]      FIG. 4  shows the display for five Subject&#39;s Stations  12 . The test administration information includes video input from each of the Subject&#39;s Stations  12 , the test and item of the testing procedure that is being administered, as well as display of controls. The controls allow the examiner to select audio input from one of the Subject&#39;s Stations, turn on the microphone to speak with the subject, and to start or interrupt the testing procedures. All tests are downloaded from the examiner console and the full suite of data provided during the test is sent to it from the Subject&#39;s Station  12 . The Examiner&#39;s Station  14  then sends the relevant data to a server in Central Data Bank  16  for inclusion in the database therein. Software may leverage existing web-based browser technology with the custom designs of the station. Using internet protocols, multiple video and audio feeds can be multiplexed into the Central Data Bank  16  from the testing stations.  
         [0054]     Software is utilized to permit interaction between the system and the subject, as well as to assist in analysis of the test findings. The system provides auditory instructions to the subject and can automatically respond to certain subject&#39;s behaviors. For example, speech recognition software may be used to recognize and digitize simple responses (numerals, letters, [and] limited word vocabulary). The system may also have a provision to flag verbal responses that cannot be recognized for later manual correction. A limited version of automated video segmentation (Liu and Kender, 2003) may be used to allow the video to be compressed temporally into relevant segments associated with responses.  
         [0055]     It should be understood that the foregoing description is only illustrative of the invention. Various alternatives and modifications can be devised by those skilled in the art without departing from the invention. Accordingly, the present invention is intended to embrace all such alternatives, modifications and variances which fall within the scope of the appended claims.  
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