Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B5/00—Measuring for diagnostic purposes; Identification of persons
  • A61B5/103—Detecting, measuring or recording devices for testing the shape, pattern, colour, size or movement of the body or parts thereof, for diagnostic purposes
  • A61B5/11—Measuring movement of the entire body or parts thereof, e.g. head or hand tremor, mobility of a limb
  • A61B5/1124—Determining motor skills
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B5/00—Measuring for diagnostic purposes; Identification of persons
  • A61B5/16—Devices for psychotechnics; Testing reaction times ; Devices for evaluating the psychological state
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B5/00—Measuring for diagnostic purposes; Identification of persons
  • A61B5/40—Detecting, measuring or recording for evaluating the nervous system
  • A61B5/4076—Diagnosing or monitoring particular conditions of the nervous system
  • A61B5/4082—Diagnosing or monitoring movement diseases, e.g. Parkinson, Huntington or Tourette
• • G—PHYSICS
  • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
  • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
  • G16H10/00—ICT specially adapted for the handling or processing of patient-related medical or healthcare data
  • G16H10/20—ICT specially adapted for the handling or processing of patient-related medical or healthcare data for electronic clinical trials or questionnaires
• • G—PHYSICS
  • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
  • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
  • G16H20/00—ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance
  • G16H20/70—ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance relating to mental therapies, e.g. psychological therapy or autogenous training
• • G—PHYSICS
  • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
  • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
  • G16H40/00—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices
  • G16H40/60—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices
  • G16H40/63—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices for local operation
• • G—PHYSICS
  • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
  • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
  • G16H40/00—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices
  • G16H40/60—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices
  • G16H40/67—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices for remote operation
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B5/00—Measuring for diagnostic purposes; Identification of persons
  • A61B5/0002—Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network
  • A61B5/0015—Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network characterised by features of the telemetry system
  • A61B5/0022—Monitoring a patient using a global network, e.g. telephone networks, internet
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B5/00—Measuring for diagnostic purposes; Identification of persons
  • A61B5/72—Signal processing specially adapted for physiological signals or for diagnostic purposes
  • A61B5/7235—Details of waveform analysis
  • A61B5/7264—Classification of physiological signals or data, e.g. using neural networks, statistical classifiers, expert systems or fuzzy systems

Definitions

• the present invention relates in general to the field of assistance devices and methods for persons having fluctuating movement disorder diseases, and in particular to monitoring devices and methods for collecting data associated with fluctuating movement disorder.
• Parkinsonian patients under treatment typically present a short-term fluctuation of disease status.
• "Short-term” is in the present disclosure intended to indicate changes occurring within a couple of hours.
• a patient can experience sub periods of an "off state, where the patient is stiff and slow in his movements and sometimes presents shaking motions.
• the patient may also have sub periods of "normal” state, where the patient responds more or less as a non- parkinsonian person.
• the patient can have sub periods of "dyskinetic” state, where involuntary movements and abnormal softness is experienced. The patient changes between these states depending on e.g. amount and type of medication, physical activity, mental activity and food intake.
• a general object of the medication is typically to give the patients as long "normal” periods as possible, minimizing both “dyskinetic” and “off periods.
• Determining treatment outcome and follow-up of patients is a complicated task. Long-time progression can be tracked in non-fluctuating patients by repeating single measurements or observations, such as indicated e.g. in [3]. However, short-term fluctuations ruin the accuracy of such approaches. In general, single or a few scattered observations will not give full information on what state a patient is normally in, how much the state varies and how much time that is spent in different states. Continuous observations by medical staff require hospitalisation which is expensive and may not be representative to the condition in the home environment.
• a general problem with prior art methods and devices for monitoring of neurological diseases is that they are not particularly well adapted to the particular needs for patients exhibiting short-term fluctuating movement disorder.
• a further problem is that measurements performed by different approaches do not generally correlate.
• follow-up with diary only will be biased by cognitive and emotional conditions, as well as changed expectations and memory problems.
• follow-up with motor tests only will be biased by motivation, learning effects and a large variation of test scores between individuals in the normal population, unrelated to disease state
• An object of the present invention is to provide devices and methods for improving monitoring of fluctuating movement disorders.
• a further object of the present invention is to provide devices and methods enabling monitoring of short term fluctuations.
• Another further object of the present invention is to provide devices and methods giving a more general description of a patient having fluctuating movement disorder.
• a yet further object is to provide an improved evaluation approach for spiral tests. It is also a further object of the present invention to provide for evaluation of effects of events such as medicine doses, food intake, exercise etc. It is also yet a further object of the present invention to provide for possibilities of individual calibration of test results.
• a test battery comprises both a motor test section and a p atient diary collection s ection.
• the motor test section is arranged for supporting motor tests and for collecting data representing results of the motor tests.
• the patient diary collection section is arranged for collecting data representing patient subjective experiences.
• the test battery further comprises a scheduler, which is arranged to restrict operation of the motor test section and the patient diary collection section to a multitude of predetermined limited time intervals. This restriction in time provides an association in time between the two types of tests, as well as a possibility for timing the test intervals dependent on e.g. the medication schedule or the daily activity schedule.
• the limited time intervals are preferably shorter than or equal to one hour, and preferably there is at least one limited time interval each 24 hours. For parkinsonian patients, at least four limited time interval each 24 hours are to prefer.
• the predetermined limited time intervals can preferably be event driven, i.e.
• the intervals can be pre-defined relative to a certain event, such as e.g. medicine or food intake, physical exercise etc.
• the test battery also comprises cognitive test means and/or psychometric measurement means.
• the test battery is preferably implemented as a portable device, enabling monitoring under home environment conditions.
• the test battery comprises test evaluation means arranged to evaluate the results of the motor tests. Over each test period, a summary of how much time that has been spent in different states and how the states varied is presented.
• the test battery may also comprise data processing means arranged to classify a momentary state of a patient performing the motor tests and providing the patient subjective experiences, preferably implemented as a fuzzy rule-based expert system, e.g. a Sugeno- style fuz2y inference system [H].
• the data processing means may also comprise means for calibrating the classification for each patient individually, by utilising calibration sessions, where test results can be correlated with a gold standard classification of motor state, e.g. using adaptive neuro-fuzzy technology [12].
• Spiral test evaluation is preferably performed utilising entropy values of drawing velocities.
• Multi-Scale Entropy analysis (MSE) with a Sample Entropy (SampEn) measure is one preferred evaluation [8], [9].
• One advantage with the present invention is that the combination of patient diary and motor tests and possibly also cognitive tests and/ or psychometric measurements gives new possibilities for interpreting evolution of data, which cannot be provided by each test separately.
• the time synchronization of the test ensures that the same state of disease is monitored.
• Other advantages with the present invention is that the scheduling of preferably several pre-planned test occasions daily gives a reliable tool to follow even short-term fluctuations, thereby evaluating e.g. different treatments.
• FIG. IA & B are block schemes of data processing and communication systems in which devices according to the present invention advantageously can be used;
• FIG. 2 is a block scheme of main parts of an embodiment of a device according to the present invention.
• FIG. 3A & B are flow diagrams of main steps of embodiments of methods according to the present invention.
• the present invention as claimed does not concern any diagnosing method.
• the patients that are subjects for the present invention are already- diagnosed having a fluctuating movement disorder, and typically receive medication therefore.
• the presence of such a disorder is instead a prerequisite of the need of the present invention.
• the present invention as claimed does neither comprise any method of treatment, since there is in the present claim no subject matter connected to any definite decisions about treatment.
• the main part of the present invention instead concerns the procedure of obtaining different measures possible to be associated with patient states, i.e. a pure data collection procedure ensuring the quality of the measurements 1 .
• a subsequent primary evaluation gives data that indeed may be used for differing purposes.
• One possible use is pure monitoring of a patient progression, a "surveillance".
• This surveillance may comprise provision of processed data supporting evaluation of different treatments and doses in a certain patient.
• Another possible use can be collection of statistics for scientific purposes, whereby the collected data is not used at all in connection with the targeted patient in any respect.
• a third use could be as a decision support for selecting suitable candidates for certain treatments, which are to be further investigated and evaluated.
• the methods and devices of the present invention can also be used to provide feed-back information to the patient, e.g. as an objective indication of the actual result of a single medication dose.
• a combination of diary questions and motor tests will therefore not only provide more data to analyse, but will also, as a synergetic effect, give inputs for a cross evaluation.
• a high score at a motor test when at the same time having a low own state assessment, may be evaluated in a different manner compared to the same score made when the own assessment was high.
• completely different analyses may be performed compared to performing the two test types just side by side, more or less independently from each other. The combination of the test methods thus provides a synergetic effect compared with a pure addition of the individual benefits.
• both motor tests and diary questioning are advantageous to perform, substantially at the same time, or at least during the same disease state.
• the time dimension is also of crucial importance, since long-term trends in the relations between motor test results and diary question answers may reveal systematic errors as well as completely new information.
• a problem when predicting outcome for treatments using statistical methods based on baseline levels is the regression to the mean [10]. To avoid this, repeated baseline measurements are required and this can be accomplished with the test battery of the present invention.
• the fluctuations of the state of movement disorder of e.g. Parkinson's disease may depend on many things.
• the type and timing of medication will of course influence the patient state considerably, as well as the method for distributing the medicament.
• a patient will be "off before the medication occasion, while the highest probability of a "dyskinesia” state, will be at a certain time after the medication took place.
• the results of tests will therefore be highly dependent on the actual occasion when it was performed.
• the patient state may also be strongly affected by mental and/or physical activity or simply by the daily routines, e.g. food intake. It is therefore of crucial importance that the test occasions are appropriately selected. Events can be documented in the test battery and trigger a test sequence.
• test occasion may be connected to a certain time of the day. For instance, tests may be performed between 08:00-09:00, 12:00-13:00; 16:00- 17:00 and 20:00-21:00, respectively, every day.
• Another possibility would be to perform the tests event-triggered, i.e. at times which are pre-determined relative to some other event.
• One example would be to perform the tests one hour after each medication occasion. In this case, the invention could be used to assess the impact of each event.
• the schedule of testing may be planned depending on the purpose of the investigation. If a mean response or a long-time stability to a certain medication is to be investigated, a few tests every day during one or a couple of weeks may be appropriate. However, if the short-term (within-day) fluctuations are to be investigated, frequent measures have to be performed. A possible schedule could e.g. be once every 15 minutes during the first two hours after each medication occasion.
• Fig. IA illustrates an embodiment of a data handling system 1 in which a device according to the present invention can be used.
• a central data server 2 is connected to a number of terminals 3.
• the central data server 2 may be implemented as one device or may be implemented in a distributed manner.
• the terminals 3 are available for physicians, researchers or other persons involved in taking care of the patients having fluctuating movement disorders.
• the terminals 3 can be used to access software 5 for evaluation of tests and a central database 6 of the central data server 2.
• the information concerning test programs, such as instructions about time schedules can be provided to the central data server 2, and data associated with results of patient tests can be retrieved from the central database 6.
• the central data server 2 is connected to a communication system 4, capable of transmitting data to and from a number of terminals 10'.
• the communication system 4 comprises an Internet network 30, to which a number of patient servers 31 are connected.
• the terminals 10 communicate with the patient servers 31, e.g. via wireless communication 32 such as IR communication or Bluetooth.
• the communication between the terminal 10 and the patient server 31 may also be provided by cables 33.
• the terminals 10 are able to communicate with the central data server 2.
• the terminals 10 receive instructions about test scheduling, which is discussed more in detail below.
• the terminals 10 typically report test results, e.g. periodically to the central data server 2.
• the results may be intermediately stored at the patient server 31, and at least parts of evaluation procedures on the test results may be performed at the terminal 10 itself or at the patient server 31.
• the central data server may in other embodiments be the sole responsible for data evaluation and processing.
• Fig. IB illustrates an alternative embodiment of a data handling system 1 in which a device 10 according to the present invention can be used.
• the communication system 4 comprises a cellular communication system 40, in which base stations 41 are in radio contact 42 with the terminals 10.
• base stations 41 are in radio contact 42 with the terminals 10.
• Fig. 2 illustrates an embodiment of a device for monitoring of fluctuating movement disorder according to the present invention.
• the device 10 consists in the present embodiment of a palmtop computer which presents a patient interface 11.
• the patient interface 11 comprises in this embodiment a touch screen 12 and a stylus 13.
• the palmtop computer typically further comprises a processor 14 having software code implementing test functionality.
• the processor 14 is arranged for interacting with the central data server 2 or the patient server 31 , if any, to load test configuration data into the palmtop via computer communication arrangements, discussed in more detail further below.
• the test configuration data may comprise a configuration file or a data base table that is used to determine which test that is going to be performed. Texts of questions and answer alternatives as well as degree of difficulty in motor tests, cognitive tests etc can be provided. Also, as further described below, scheduling of the test can also be provided this way.
• a motor test portion 15 of the processor 14 provides test configurations to the patient via the touch screen 12.
• the patient responds to the test configurations by touching the touch screen 12 in certain positions with the stylus 13.
• the position of the contact is interpreted as a test result by the motor test portion 15.
• the test results are stored in a local storage 16, waiting for further transmission to a central data base, c.f. Fig. 1.
• a motor test section 17 of the device 10 of the present embodiment comprises thereby the motor test portion 15 of the processor 14, the touch screen 12 and the pointer rod 13.
• the motor test section 16 is thereby arranged for supporting motor tests and for collecting data representing results of the motor tests.
• a diary question section 18 of the processor 14 provides diary questions to the patient via the touch screen 12.
• a patient diary collection section 19 of the device 10 of the present embodiment comprises thereby the diary question section 18 of the processor 14, the touch screen 12 and the stylus 13.
• the patient diary collection section 19 is thereby arranged for collecting data representing patient subjective experiences.
• the patient diary collection section 19 and the motor test section 17 comprise a patient interface 11.
• both sections 17, 19 utilise the same patient interface 11.
• the motor test section 17 may utilise one patient interface and the patient diary collection section 19 another.
• the patient interface 11 comprises in the present embodiment a touch screen 12 and a stylus 13.
• a screen showing the questions could be combined with physical button, used for inputting the patient answers.
• the questions could even be provided to the patient in an audio manner, e.g. by retrieving a voice question through the loudspeakers.
• the patient interface for the motor tests can also be implemented differently and any prior-art approaches, such as using physical buttons to press or using a joy stick may be utilised also together with the present invention.
• instructions may be given by a voice via the loudspeaker.
• the device 10 further comprises, according to the present invention, a scheduler 20.
• the scheduler 20 is implemented in the processor 14.
• the scheduler 20 controls the time intervals, during which the motor test section 17 and the patient diary collection section 19 can be accessed.
• the scheduler 20 is thereby arranged to restrict operation of the motor test section and the patient diary collection section to a multitude of predetermined limited time intervals.
• These predetermined limited time intervals can be event driven, i.e. determined relative a certain event, such as a time of medication, food intake, exercise etc. Such event driven time intervals will also be discussed further below.
• the device 10 comprises also communication arrangements, in the present embodiment in the form of a transmitter 21 and an antenna 22 as well as a data communication interface 23. These communication arrangements are used for transmitting the collected data to a database server (c.f. Fig. 1) e.g. via a mobile communication network and/ or via data communication cables.
• the transmitter 21 is thereby arranged to allow for transfer of data, e.g. data temporarily stored in the storage 16, over e.g. a radio communication system. Such a system could e.g. be based on a mobile telephony standard or on Bluetooth technology.
• the data communication interface 23 is arranged for allowing the collected data to be transferred by cable, e.g. using standard USB technology.
• the communication arrangements can also be utilised for providing the device 10 with input data.
• the data communication interface 23 can for instance be used e.g. as a staff interface to assign patients and possibly for period identification, i.e. setting the scheduler 20 to provide an appropriate set of predetermined limited time intervals. A trained physician or nurse may thereby remotely specify at what occasions the tests are going to be performed. Also test definitions and question texts can be provided this way.
• the communication arrangements are also suitable for providing feed-back information to the patient.
• Patients are typically very curios about their state and may be very eager to know e.g. what the last test period results were.
• the main evaluation is performed at the central data server, it is useful to provide some feed-back data to the patient, for knowing e.g. if the last medicine dose had the intended effect.
• such medication equipment may communicate data concerning medication times and amounts of medication to the device 10, using the communication arrangements or any separate external interface 27. This can e.g. serve as input data for setting event driven predetermined limited time intervals. Such relative test periods can be utilised when evaluating the medication effects on individual medication events.
• a first screen in the test display of the touch screen is presented.
• This appearance of the first screen may also be provided automatically at the start of a predetermined limited time interval, preferably connected with e.g. some sound signal to catch the attention of the patient.
• the screen presents a button icon with the text "start diary” appears. This button is only active during the multitude of predetermined limited time intervals, as controlled by the scheduler 20.
• the "start diary” button is pressed, a number of diary questions are presented, on which the patient is supposed to answer.
• One example of a typical question that has been used in [7] is "Have you had difficulty walking about 100 meters during the last four hours?".
• a number of answering alternatives are presented, such as “not able at all”, “difficult”, “with efforts”, “pretty well”, “without problems”.
• the patient touches the touch screen, preferably by the stylus 11 at the appropriate choice.
• a new question is then shown, e.g. "Have you been "off (stiffness/ slowness/ shakings) during the last four hours?".
• Answering alternatives could then be "all the time”, “most of the time”, “half of the time”, “a smaller part of the time” and “not at all”.
• the patient could be given a graphical representation of the four hours and be asked to divide the representation into three parts, representing the amount of "off time, "dyskinetic” time and "normal” time.
• a number of such questions typically seven selected questions and one or two questions on mental mood are presented to the patient. Typically, 5 alternatives are given for the answers or the patient could himself make an indication on a scale.
• the questions appearing in the diary part of the tests are only possible to be answered once in each time interval. So, when all questions have been answered, it is no longer possible to activate any "start diary button” again until next time interval.
• a first example of a motor test can be a standard tapping test.
• the screen presents two coloured squares and the patient is instructed to tap on the squares in an alternating manner as fast as possible during e.g. 60 seconds.
• the areas corresponding to the squares are then active for registering taps during 60 seconds from the first tap. Absence of audio or visual triggers assures that pure motor function is measured. Estimates of speed (number of taps/min), rhythmicity (standard deviation of tap times) and spatial accuracy (number or missed or double clicked squares) are calculated and stored.
• a second example is tapping with increasing speed.
• two squares are presented at the screen, one red and one grey.
• the colour switches according to a predetermined schedule having an increasing speed.
• the patient is instructed to tap the squares alternately when the red colouring shifts.
• this test is performed e.g. during 60 seconds. There will possibly be a sound connected to movement of the red colouring, e.g. by means of a loudspeaker 25.
• the patient should try to tap all red squares. Number of correct and incorrect taps are calculated and stored. Possibly, a break-point in the relation speed vs. proportion of incorrect taps could be recorded.
• Another alternative is to record an n:th failure time, i.e. the time to the n:th incorrect tap.
• a third example is a random chase test.
• a screen with four squares is presented. One of the squares is red and the colouring shifts in a random manner between the squares. The patient is instructed to tap all red squares as fast as possible. The test starts when the first red button is tapped and continues for e.g. 60 seconds. When a red button is tapped, another button (randomly selected) will turn red. The same data as in the standard tapping test is calculated and stored, preferably together with an identification of the square that was tapped. This is a semi-cognitive test which will assess the function between eye and hand.
• a fourth example is a spiral test, which is found to be a test type giving much useful information.
• a spiral is presented on the screen.
• the spiral is preferably an Archimedes spiral following the definition of:
• the constant a defines the spiral and is adjusted such that the spiral fits into the screen on three rounds about the origin.
• the patient is instructed to follow the pre-drawn spiral from the centre outwards with the stylus as accurate and fast as possible.
• the position and times for the stylus are recorded.
• original coordinates are transformed to polar form with the origin placed in the centre of the spiral.
• the drawing velocity in r , ⁇ , x and y directions are obtained by differentiation.
• the drawing velocities in different directions are Fourier transformed and frequency-filtered to detect involuntary movements of different frequencies as described in [13]. This test will thus mainly assess involuntary movements such as high frequency (5-10 Hz) tremor and lower frequency (1-5 Hz) dyskinesias. Standard deviations of frequency filtered drawing velocities could also be of use as well as average of corresponding mean accelerations for each direction.
• Quality validation of drawn spirals is preferably done according to the following rules:
• the number of coordinates must be larger than some threshold value.
• the mean square deviation from the pre-drawn spiral must be smaller than some threshold value.
• Entropy values of drawing velocities are preferably calculated with use of the Multi-Scale Entropy (MSE) method with the sample entropy (SampEn) measure.
• MSE Multi-Scale Entropy
• SampEn sample entropy
• This test can be generalised and added to the present test battery such that the hands of a clock can be moved, by the patient, e.g. by pointing by the stylus on the touch screen presenting a clock, to indicate different times.
• a text or voice asks the patient to set the clock to indicate a certain time. The time to be set is randomly changed each time the test is performed.
• Another widely used cognitive test is pattern matching. This is implemented in the present battery such that the screen shows a selection of different symbols in one or two rows. One of these symbols is shown again in a box below and the patient is asked to tap the matching symbol in a row above. The symbol in the box will be randomly selected each time the test is performed.
• the device registers preferably question identification, time, given answer and correct answer.
• cognitive test results can advantageously be used in an integrated analysis with motor tests and diary questions. Cognitive test results may e.g. also contribute to interpret long-term variations as described more in detail above.
• the motivation of a patient may also influence the test results. Observations concerning mental mood and attitude can thereby give additional information about how to interpret the results of other tests. Questions about mental mood at the time for performing test may e.g. be included in the diary questions, as described further above. However, also other psychometric tests may be useful. A simple arrangement for measuring the skin resistance may for instance give indications of stress levels of the patient.
• the MSE method is also advantageously applied for evaluation of the motor tests as well as of psychometric measurements and diary answers for the whole period.
• test results When the tests and questions are performed, the results have to be compiled and processed. Such tasks can be performed at different stages in the system.
• a first compilation of test results is preferably performed already in the portable palmtop computer. Compilation and evaluation can also be performed at different stages in the communication chain to the central data server, e.g. at a patient server (c.f. Fig. IA) or at the central data server. If compilation and/ or evaluation is performed early in the reporting chain, the amount of data that is necessary to transmit will be decreased. However, it is also possible that the device collecting the data sends all primary data directly to the central data server before any data treatment at all is performed.
• Compilation of test and question data is preferably performed by applying a scaling of measurements of each test parameter.
• the single question answers and test results can then be weighted together, e.g. using a fuzzy logic inference system to a common scale, in the Parkinson case e.g. having the grades [-3, +3], where -3 represents severe off, 0 is normal and +3 is severe dyskinesia.
• the limits for the classification based on e.g. "high”, “low” etc. are to a high degree “fuzzy”. Fuzzy classification of test parameters can be utilised by use of fuzzy logic membership functions. The meaning of "high”, "low” etc. will then be defined e.g.
• Multivariate scaling of test parameters can also be applied, i.e. more than one test result may be utilised when determining the value of a parameter.
• a combination of e.g. answers to diary questions and motor test can easily be performed already in the compilation step. For instance, a "bad" test result may be caused either by an "off condition or a "dyskinetic” condition. If a bad test result, e.g. low tapping speed, occurs when the patient is "dyskinetic", the multivariate parameter could be set to +2, while the -2 is reserved for a low tapping speed test result occurring when the patient is "off according to his own assessment.
• the compilation of individual test results to more global state variables is preferably performed using a fuzzy rule-based expert system, preferably a Sugeno type fuzzy inference system (FIS) [11] using expert rules.
• FIS Sugeno type fuzzy inference system
• the compiled and evaluated test results are further processed for classifying a momentary state of the patient performing the tests.
• processing is preferably performed utilizing an adaptive neuro-fuzzy inference system (ANFIS) [12]. This requires a calibration period with gold standard classification e.g. on the [-3, +3] scale.
• AFIS adaptive neuro-fuzzy inference system
• OPS Patient State
• MTS Motor Test State
• MMAS Mental Mood & Attitude
• the momentary states are calculated e.g. as:
• MTS FMTS (tap speed; rhythmicity; proportion of correct taps; breakpoint; failure time; MSE values; area; drawing velocities and accelerations)
• MMAS FMMAS (diary question; psychometric measures)
• the various 'functions' FOPS FPS FMTS FCS FMMAS can be expressed by Sugeno type FISs [11] defined in consensus with expert physicians.
• the primary momentary OPS, PS, and MTS state variables can be expressed on the scale [-3, +3] where:
• Antecedents of all these rules will get a truth value between 0 and 1.
• 'And' and 'or' operators can be compiled using 'min' and 'max' membership values, respectively.
• This MTS value is then rounded to nearest integer
• OPS weighted_average (MTS,PS) else flag conflict end if (An alternative is to use a FIS even in this case).
• Y 1 stands for a combination of the m momentary state values, for instance, in the Parkinson case, calculated fraction off- time / good time / dyskinetic time, mean squared deviations, maximum, median and minimum values, frequencies of each state [-3, +3]
• the off- time can e.g. be defined as time spent in -3 and -2 states, the good time as time spent in -1, 0 and +1 states and the dyskinetic time as time spent in +2 and +3 states.
• the data processing preferably comprises functionality for individual calibration.
• the purpose of calibration is to acquire a test result that can be comparable between patients. Since different patients experience symptoms differently, answers on diary questions may differ significantly between patients. Some patients have a high tolerance level and always give answers close to a medium value. Other patients react very much on every tendency of symptoms, and will often indicate extreme answers. Also motor tests are somewhat influenced by individual patient response. Some patients may- cover symptoms in a more efficient manner than other patients. In order to compare results from different patients, some sort of calibration is preferred.
• film sequences may be recorded while the patient performs well defined motor exercises, e.g. walking. These recordings could then be transmitted to a central server and rated by a trained physician or nurse in order to obtain some kind of pragmatic calibration standard. Such rated film recordings performed during an initial period of calibration in direct connection before or after the various tests could then be used to establish a multivariate calibration function, to be used for transformation of the set of motor function test parameters from each test occasion into a provisional gold standard score value, e.g. on the [-3, +3] treatment response scale (TRS) [7].
• TRS treatment response scale
• the calibration function can be established with use of e.g. Adaptive Neuro- Fuzzy Inference Systems (ANFIS), (also known as Adaptive-Network-Based Fuzzy Inference Systems) training of the already defined FISs.
• ANFIS Adaptive Neuro- Fuzzy Inference Systems
• An alternative to video-recording in the home could be to use the test battery at the hospital at the same time as when doing gold standard ratings on the TRS scale. These measures are then used as gold standards for an individual calibration.
• Fig. 3A a flow diagram of main steps of an embodiment of a method for collecting data associated with fluctuating movement disorder according to the present invention is illustrated.
• the procedure starts in step 200.
• step 210 a multitude of predetermined limited time intervals are determined. Answers of diary questions are collected in step 220.
• step 230 motor tests are performed and in step 232, results of the motor tests are collected.
• step 240 cognitive tests are performed and in step 242, results of the cognitive tests are collected.
• psychometric measurements are performed in step 250.
• Fig. 3B a flow diagram of main steps of an embodiment of a method for provision of data supporting evaluation of treatment of fluctuating movement disorders according to the present invention is illustrated.
• the procedure starts in step 300.
• step 310 data are collected according to the procedure illustrated in Fig. 3A.
• step 320 a multitude of momentary states of a patient are classified, based on data representing results of the data collected in step 310.
• step 330 a compilation of the classified results is provided.

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