AU2006252068A1 - Method and device for detecting neurological and psycho-physiological states - Google Patents

Description

P001 Section 29 Regulation 3.2(2)

AUSTRALIA

Patents Act 1990 COMPLETE SPECIFICATION STANDARD PATENT Application Number: Lodged: Invention Title: Method and device for detecting neurological and psycho-physiological states The following statement is a full description of this invention, including the best method of performing it known to us: METHOD AND DEVICE FOR DETECTING NEUROLOGICAL AND PSYCHO- SPHYSIOLOGICAL STATES FIELD OF THE INVENTION The invention is directed to a biofeedback method for the detection and self-regulation of neurophysiological and psychophysiological states in which a user's biosignals are determined and evaluated and to a device for carrying out 00 11the method.

N BACKGROUND OF THE INVENTION c In the field of biofeedback, and particularly of EEG biofeedback or neurofeedback, there exist different systems, devices and processes for use in Sclinical practice as described, in the patents cited in the following.

US 5,740,812 concerns a method and apparatus for EEG biofeedback while carrying out defined tasks, working at the computer, playing a game, etc.

The associated apparatus comprises headphones to which EEG sensors are attached. The detected EEG signals are then evaluated by means of a computer and the concentration and alertness of the human subject are indicated by means of audio feedback and visual feedback.

US 5,465,729 and US 5,343,871 describe devices for audio feedback and video feedback in which audio-visual sequences simulate real scenes, so that desired psychic states can be induced. Activation of the desired physiological parameters is rewarded. In so doing, control over these parameters is made possible by remembering the shown sequences.

US 5,406,957 discloses a biofeedback device for the feedback of frequency bands determined by EFT. The feedback is presented in the form of acoustic signals or spoken words.

US 5,036,858 shows a device for audio feedback and visual feedback in which the calculated EEG frequency and the difference with respect to the desired frequency are presented simultaneously.

US 5,024,235 discloses a device for audio feedback and video feedback in which the amplitude of an EEG frequency band is determined and is displayed in comparison to a threshold.

0 US 3,890,957 describes a device for audio feedback in which a DC signal Sis generated corresponding to the zero crossings determined in the detected 0 signal and this DC signal is used for modulating an audio output.

In the apparatus for biofeedback known from US 3,821,949, determined signal frequencies are determined in several channels simultaneously and corresponding acoustic signals are generated as output after reaching a 00 0 reference value.

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N The commonest solutions with respect to technical equipment offer the Spossibility of feeding back a plurality of physiological signals such as EMG, temperature, breathing, skin conductivity and EEG. In the field of feedback of Shuman brain activity, there are devices which achieve the feedback of different EEG components such as theta rhythms, alpha rhythms and beta rhythms, SMR rhythm or ratios of these brain activities. The existing devices offer the trainer the limited selection of determined neurofeedback protocols, wherein prescribed electrode positions are used. A biofeedback method that is used very often for a wide variety of different neuronal diseases is based, for example, on the SMR rhythm. However, this is usually carried out in a highly nonspecific manner because the existing technology does not offer enough flexibility or room for individualized treatment.

Problems with the requirements for a successful biofeedback strategy grow out of the limitations of commercially available EEG technology: the measurement hardware usually does not allow reliable detection of specific signal components, the software supplied is usually oriented to routine EEG examinations and implements only conventional evaluating processes. A continuous online-capable monitoring of the changes in frequency and amplitude of fundamental rhythms is necessary for control of the feedback in EEG learning processes. Known EEG feedback controls are based on evaluations within longer time windows or signal segments. Therefore, acknowledgments of successful rhythm control are possible only in intervals of several seconds. In particular, there is a lack of high-resolution methods with respect to time and frequency and topographic methods by which the dynamics of brain processes can be explored online while taking into account the stochastic EEG character.

Accordingly, the preconditions for understanding the delicate temporal O microstructure of physiological and pathological brain events are nonexistent.

i Methods for detecting the specificity of neurofeedback therapy are also lacking abecause the various influencing factors and the features suitable for validation can not be adequately extracted and controlled.

Further, practice has shown, for example, in the training of epileptic users based on slow potentials, that the biofeedback sessions should be conducted at 00 I least 2 to 3 times per week over a period of several months. This is difficult to i achieve in the case of working or out-of-town users and this type of treatment is i often discarded for this reason. Difficulties also arise in a follow-up phase in

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10 which the user has no possibility of monitoring the correctness of the exercises i due to the lack of apparatus.

It would be desirable to provide a method and a device of the type mentioned at the outset, by way of which specific indications for a userpersonalized multi-parameter profile can be detected, and which profile can be used for a monitored initial training and which can also be used outside of the training session.

SUMMARY OF THE INVENTION In a first aspect of the present invention, there is provided a biofeedback method for detecting and influencing neurological and neuropsychological states in which a user's biosignals, particularly spontaneous and evoked brain activity and interactions between the latter and other physiological systems, are determined and evaluated, characterized in that a user specific profile for the choice of an individual training protocol is compiled at and stored in a central unit with a profiler decision support system, in that software components associated with the training protocol are configured at the central unit and transferred to a modular portable unit which is outfitted with means for communicating with the central unit, in that the central unit and the portable unit are arranged for delivery of training of activities to the user, and in that subsequently to an initial training, an objective validation of a biofeedback strategy is carried out at the central unit by means of signal-analytic methods and statistical comparisons with an initially determined neurological and neuropsychological state and/or a standard collective.

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O In a second aspect of the present invention, there is provided a device for Scarrying out the method according to one of claims I to 11, characterized in that a the device contains a central system and a portable system, wherein the central system contains a flexible, multichannel system, and a profiler decision reinforcement device is integrated in the centralsystem, and the portable system contains a modular, individually adjustable mobile device.

00o IDIn yet a further aspect of the invention there is provided a biofeedback c method for detecting and influencing of neurological and neuropsychological C states of a user, including the steps of: 0 10 a) determining and storing data representative of initial neurologic and Sneuropsychologic states of a user and interaction thereof with other physiological systems of a person, based on an evaluation of electroencephalograms, event related Potentials and/or other polygraph-detectable signals such as in vertical electrooculograms, horizontal electrooculograms, electrocardiograms, said determination being carried out using a central unit having associated hardware and software configured for neurological and physiological signal recordal and processing, and data evaluation and storage required to effect said determination; b) based on data obtained in step creating a user-specific profile and deriving therefrom, using the central unit, a user-specific training protocol having initial set-up parameters and target parameters; c) configuring portable units with the user-specific training protocol, the portable unit being arranged for neurological and neuropsychological interaction with the user; d) conducting a user-training session at the central unit and/or the portable units, during which the user carries out activities that influence one or more neurological or neuropsychological states; e) recording of neurological and neuropsychological responses during the user-training session and evaluating data associated with said responses at the portable unit; f) adaptively changing, as required, the initial set-up parameters of the user-specific training protocol as a function of the evaluation step and the target parameters of the user-specific training protocol; O g) storing of data recorded during the user-training session at the N central unit; and h) validating, at the central unit, of the user specific profile using signal-analytic methods and statistical comparisons with the initially recorded neurological and neuropsychological states of the user and/or a standard collective.

00 IIn particular, with the present invention, one can provide a user-specific 0 cI biofeedback system for spontaneous and evoked brain activity and the c-i influencing thereof in interactions with a physiological systems of the user, the 0 10 system being advantageously embodied in a central unit and a separate, portable CI unit.

The invention makes it possible to realize a flexible, integrated multichannel system comprising components for specifically indicating a multiple, personalized profile and for a monitored initial training. Based on the protocol which is adapted to this central system, transfer to a modular, individually adjustable mobile device for home use or for use outside the trainer's practice can be carried out, for example, for use during a follow-up phase. Accordingly, monitoring, control and evaluation of the plurality of sessions taking place simultaneously, but not necessarily at the same location, and readjustment of the biofeedback protocols via Internet or communications protocols can also be realized.

The invention is characterized in particular by the following advantages: The invention is realized by a central system and portable miniature system that can be coupled to this central system; a profiler which is integrated in the central unit serves as a decision support system for preparing a user-specific profile used as a basis for the choice of activities to be taught and the objective validation of the biofeedback strategy by means of signal-analytic processes and statistical tests compared to an initial state and a standard group; a freely interactive arrangement of biofeedback protocols by the trainer in the form of mathematical functions is possible, e.g., (Aa(Ol)+ Aa(Oz)+ Aa(02))/AO(Oz) O sum of the amplitudes of alpha activity under electrodes 01, Oz, 02 divided c by the amplitude of the theta activity under electrode Oz (P[1 O-12j(Oz))/(P[8-1 SOjOz)) ratio of the instantaneous output (electrode Oz) of the activity in the frequency range 10<=f<=12 Hz compared to activity in the frequency range of 8<=f<10 Hz 00 oo IDF(P3) c instantaneous frequency of activity under electrode P3 ASMR(C3) VSMR amplitude position 03 SCP(Cz) Slow cortical potential under Cz C(C4) local coherence position 04; the configuration of the software for the portable system is realized by joining individual software components when setting the protocol in the central system and transferring from the central system to the portable system; the monitoring, control and evaluation of the sessions and the readjustment of the biofeedback protocols can be carried out through the Internet (for example, through the use of an integrated web chip) or by means of communication protocols; the monitoring and control of a plurality of sessions which take place simultaneously but not necessarily at the same location and which are carried out with the portable system is made possible by means of the central system via a biofeedback monitoring device within therapy offices, hospitals and studios or by means of biofeedback telemonitoring while training, at home; the free choice of feedback channel or cortical localization speech center, music center, etc.) can be carried out with simultaneous monitoring of the real signals and the feedback parameters of all detected channels at the central system; there is the possibility of simultaneous detection of EEG components such as theta rhythms, alpha rhythms and beta rhythms and similar EEG rhythms of slow components (SCP) and other polygraphic signals; the possibility of integrating interactions with other physiological systems whose processes can be trained in a reinforcing manner is likewise realized, and O their influences and the correlative and functional relationships with the primary N feedback process is constantly monitored (example: monitoring and feedback of a the relationship between slow brain potential and breathing); there is the possibility of detecting abnormal brain activity, particularly of epileptic graphic elements and the need for biofeedback training; further, there is the possibility of detection and feedback of evoked 00 I potentials through the use of many visual, acoustic and cognitive stimuli at the c central nervous system, for example, through coupling with a visual or acoustic i perimeter or other visual, acoustic, somatosensory stimulation units; 0 10 it enables variable duration and capability of combining the feedback trials, i interstimulus intervals and pauses at the central system; the choice of different signal processing methods or parameters for the same channel or for different channels and their simultaneous display for optimizing the feedback protocol at the central system; the use of adaptive-recursive estimates as a basis for the continuous online control of the feedback; it contains multimedia feedback modules which can be configured individually by the trainer or also by the user, as the case may be, by selecting or importing music files, film files, images or vibrations; the sensitivity of the feedback can also be set individually; the control of films as feedback, for example, playing the film, is carried out only until the corresponding activity is controlled in the desired direction; otherwise, the playback is stopped; the central system is advisably implemented as a two-monitor system (user monitor and trainer monitor), either as a 2-PC system (communication via RS232 or TCP/1P, for example) or as a I-PC system with the use of internal communications DDE, TCP/IP); it enables compatibility with current polygraphic and EEG systems and accordingly enables realization based on commercially available equipment and does not require any special hardware solution; it is possible to choose between monitor, video panel, video glasses or display worn on the head for feedback;

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O the portable miniature system can be realized on the basis of portable Scomputers, body-worn computers, palmtops or play stations.

O The high degree of functionality and flexibility and the possibilities for individual optimization not only increase the efficiency of neurofeedback training, but new perspectives in treatment are also opened up by the design of new biofeedback protocols. Not least, the portable solution allows the user an o00 N economical alternative that does not depend on appointments and accordingly 0 N permits free planning. Further, by combining a central system with several N portable systems, biofeedback monitoring spaces can be set up for monitoring the user and less personnel is required.

C An embodiment of the invention will be described more fully in the following with reference to the accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS Figure 1 shows the sequence of method steps of the biofeedback method according to one aspect of the present invention; Figure 2 shows the flowchart of a neurofeedback training; Figure 3 shows a schematic view of the neurofeedback system; Figure 4 shows a function chart of the neurofeedback system; and Figure 5 shows a block wiring diagram for a miniaturized portable unit.

DESCRIPTION OF PREFERRED EMBODIMENT As can be seen from Figure 1, the quantification of the EEG (QEEG) derived by long-term monitoring forms the starting point of the method. In this way, characteristic quantities describing the state of the user can be obtained from the EEG that was recorded while resting or, depending upon the application, during different provocation methods. By means of a predefined vector of parameters, a user-specific profile is made. In addition to the quantities occurring through the quantification, user-specific data such as, information about the spontaneous emotional state and the environment, prior history, results oflQ test or psychological tests, are also recorded in this profile. The user-specific profile is then used for determining the strategy in neurotherapy or in biofeedback. During the first biofeedback sessions to be defined as initial, a monitoring of the real signals and feedback parameters is carried out via all detected channels. A choice of different signal processing methods for one channel or different 9 O channels is also possible. After determining the optimal methods for the user C choice of activity, cortical localization, calculation method, triggering of start 0 of feedback, and modalities of the stimulation paradigms in case of evocation a determined quantity of training procedures can be carried out either at the central system or at the home system (after transferring the corresponding modules).

Long-term monitoring can then be carried out followed by quantification. The 00 I profile is continually expanded by the newly obtained parameters. Based on 0 N selected statistical methods and according to predefined criteria, comparisons N can be made between the state vectors. The results are used to assess the success of the applied neurofeedback therapy. The results of the evaluation Nserve for adapting the treatment methods. This would mean that when an activity is not successfully controlled, this control can be replaced in future therapy sessions by the control of another activity or by combining the controlling of different EEG parameters.

Figure 2 shows the sequence of a neurofeedback training.

As can be seen in Figure 3, the central biofeedback system comprises the following components: control of measurements and stimulation, signal detection, signal processing, signal presentation, feedback and stimulation (optional).

The use of multi-channel derivations in neurofeedback investigations is essential for the initial phase. This procedure allows an appreciable improvement in observation of the correlation of functional and morphological findings. It is to be expected that a user-specific and more effective neurofeedback therapy can be designed by taking into account the topographic peculiarities of the pathological EEG signals and by means of efficient online monitoring. Further, other biological signals should be derived simultaneously. In this way, valuable conclusions can be made about time-correlating accompanying phenomena or other physiological or pathological processes and can be taken into account in the biofeedback.

In order to achieve the possibility of complete infoffilation about the physiological processes taking place, polygraphic data containing, the EEG, VEOG, HEOG, EKG and breathing curve can be recorded. Positions of established EEG derivation systems are used for derivation of the EEG. The derivations are carried out referentially against the connected mastoids. Other O montages such as transverse, longitudinal and temporal are possible. The transitional impedances are brought to values of less than 3 kQ. The filter is set Sin the range of 0 70 Hz, where DC (0 Hz) is necessary predominantly with the derivation of slow potentials (SCP). The sampling rate is between 100 and 500 Hz. The derivation of the rest of the signals is carried out in a bipolar manner. The EEG and EOG are carried out using offset- and drift-reducing electrodes. The 00 IND breathing curve is recorded by means of a breathing belt. The biofeedback c training following the initial examination and feedback session is carried out using c a sharply reduced quantity of electrodes which depends on the selection of activity.

C Use of the neurofeedback system should be flexible and in so doing should give the trainer the possibility of experimental examinations. For this reason, the preconditions should be created for monitoring both evoked and spontaneous activities. In the first case, numerous stimulation procedures are required in addition to the provocation methods established in the neurological routine. SI-S2 paradigms, the oddball paradigms, visual stimulation by means of a checkerboard or perimeters are some examples of this.

The- demand for flexibility implies taking into account a greater quantity of spontaneous and evoked brain activity components. Above all, signals are selected whose experimental use in the framework of a neurofeedback procedure was connected with a positive therapeutic effect. Examples of such EEG rhythms are theta rhythm, alpha rhythm, beta rhythm, SMR rhythm or combinations thereof.

The CNV, CPV, P300, YEP et al. belong to the field of ERP. Additional relationships between different cortical localizations such as bilateral asymmetries, bilateral and local coherences are included. The superposition of relevant EEG signals with a plurality of artifacts of biological and nonbiological origin makes efficient pre-processing indispensable. A compromise must be made in the selection of methods and algorithms for purposes of an optimal signal quality.

The signal processing routines form the core of a neurofeedback system.

The results of the evaluation of potentials are used in four different ways: for artifact reduction; O for presentation of results and monitoring by the trainer or medical i technician; a combination of the directly measured and calculated value can be 0 prepared and displayed; for controlling feedback; for subsequent offline evaluation of the neurofeedback session and for statistical comparison with the preceding sessions or with existing averages.

oo00 I In the first three cases, only online-capable methods can be used or 0 i methods in which the evaluations are carried out based on epochs (quasi-online).

N Methods of the following groups are implemented depending on the type of 0 10 calculation: Smethods based on windows, the FFT, baseline calculation, averaging, correlations, VEGG correction, HEOG correction; recursive methods such as adaptive-recursive estimates (ARE).

Controlling by means of the control characteristic quantities calculated from the measurement data gives the instantaneous state of feedback for a determined, measured physiological state of the user. The actual feedback consists in that this state is perceptible acoustically, visually or audiovisually) by the user through a multimedia presentation and a change in this state, within the framework of the training procedure, is first detected by means of this presentation and can then be trained. The arrangement of the feedback should be carried out in a simple manner that is not too complex and should be agedependent. In the system shown herein, the feedback is realized in the form of high-quality animation, films, musical pieces or vibrations that can be controlled via RS232, DDE or TCP/IP. Movement-oriented and achievement-oriented types are implemented. It is possible to adapt the triggering of feedback to the possibilities of the user (within the individual parameter range of the signal to be controlled). The data files required for the control mechanism (images, music, films) can be introduced in determined formats as desired by the trainer and possibly by the user.

The basis of the central system is formed by a polygraphic EEG device (DC-AC amplifier). This offers the possibility of flexible design of the measurement arrangements. A possible configuration would be, 28 unipolar channels for EEG and 4 bipolar channels for VEOG, HEOG, EKG and breathing.

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Figure 4 shows the function chart of the neurofeedback system. In order to c produce the required feedback, the data stream must first be transferred from the a amplifier to the measurement computer. Subsequently, a characteristic quantity used for controlling the feedback is calculated from the raw data.

The design of the control of the feedback by the three paths described above (by RS323, DDE or TCP/IP) allows the central system to be realized 00 oo 11through the use of two PCs and two screens or also by means of one PC and one c or two screens. The portable unit is realized based on portable computers, bodyc worn computers, palmtops or play stations. Either current monitors, TFT 0 10 displays, or special LCD glasses with integrated headphones, a personal C LCD monitor or head-mounted display, can be used in the central and portable systems. The above- mentioned possibilities allow an additional miniaturization and mobile use of the portable solution. An arrangement of this kind is shown in the chart in Figure

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O ABBREVIATIONS SQEEG quantified EEG EEG electroencephalogram EKG electrocardiogram BF biofeedback 00 IN NT neurotherapy C- NF neurofeedback CN S1, S2 stimulus 0 10 ISI interstimulus interval CI SCP slow cortical potential DSV digital signal processing VEOG vertical electrooculogram HEOG horizontal electrooculogram DDE dynamic data exchange EMG electromyogram FFT fast Fourier transform VEP visually evoked potential ERP event-related potential CNV contingent negative variation CPV contingent positive variation TCP/IP transmission control protocol over Internet protocol PC personal computer EOG electrooculogram

Claims (26)

1. Biofeedback method for detecting and influencing neurological and neuropsychological states in which a user's biosignals, particularly spontaneous and evoked brain activity and interactions between the latter and other physiological systems, are determined and evaluated, characterized in that a user 0specific profile for the choice of an individual training protocol is compiled at and stored in a central unit with a profiler decision support system, in that software ccomponents associated with the training protocol are configured at the central Sunit and transferred to a modular portable unit which is outfitted with means for N communicating with the central unit, in that the central unit and the portable unit are arranged for delivery of training of activities to the user, and in that subsequently to an initial training, an objective validation of a biofeedback strategy is carried out at the central unit by means of signal-analytic methods and statistical comparisons with an initially determined neurological and neuropsychological state and/or a standard collective.

2. Biofeedback method according to claim 1, characterized in that a multiple, user-personalized neurofeedback profile is determined by a flexible integrated multichannel central system and is taken as a basis for preparing a training protocol.

3. Biofeedback method according to claim 1 or 2, characterized in that a free interactive arrangement of biofeedback protocols is carried out by the trainer by defining mathematical functions.

4. Biofeedback method according to one of claims 1 to 3, characterized in that the feedback channel or cortical localization is selected with simultaneous monitoring of the real signals and feedback parameters of all detected channels. Biofeedback method according to one of claims 1 to 4, characterized in that abnormal brain activities are detected and the user is notified of the need for a biofeedback training.

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6. Biofeedback method according to one of claims 1 to 5, characterized in Sthat individual software components are configured by the choice of protocol and 0 are transferred to the portable system.

7. Biofeedback method according to one of the preceding claims, characterized in that a coupling of the central device and portable device for the 00 0monitoring, control and evaluation of the sessions and for the readjustment of the cbiofeedback protocols is carried out by transmission via the Internet or by means of communication protocols. INO

8. Biofeedback method according to one of the preceding claims, characterized in that EEG components, ERP and/or other polygraphic signals are detected simultaneously.

9. Biofeedback method according to one of the preceding claims, characterized in that interactions with other physiological systems are taken into account and trained in a deliberate reinforcing manner, wherein their influences and the correlative and functional relationships are constantly monitored.

Biofeedback method according to one of the preceding claims, characterized in that evoked potentials are detected and/or controlled through the use of visual, acoustic and cognitive stimuli.

11. Biofeedback method according to one of the preceding claims, characterized in that different signal processing methods or those with different parameters for the same channel or for different channels are displayed simultaneously.

12. Device for carrying out the method according to one of claims I to 11, characterized in that the device contains a central system and a portable system, wherein the central system contains a flexible, multichannel system, and a profiler decision reinforcement device is integrated in the centralsystem, and the portable system contains a modular, individually adjustable mobile device. NO O

13. Device according to claim 12, characterized in that the central system and c the portable system contain interfaces for the Internet and/or communication U a protocols.

14. Device according to claim 12 or 13, characterized in that the device contains means by which a monitoring and control of a plurality of sessions taking oO 00place simultaneously is realized by the central system in the same location for the C purpose of NF monitoring or at a distant location for the purpose of NF c telemonitoring.

NO Device according to one of claims 12 to 14, characterized in that the central system and the portable system are coupled with devices for visual, acoustic and/or cognitive stimuli.

16. Device according to one of claims 12 to 15, characterized in that the device contains means by which the duration and capability of combining the feedback trials, interstimulus intervals and pauses is selected variably and individually.

17. Device according to one of claims 12 to 16, characterized in that the device contains means by which films and/or musical pieces and/or images and/or vibrations are integrated by the trainer or user.

18. Device according to claim 17, characterized in that the device contains means by which the control of films is integrated as feedback..

19. Device according to one of claims 12 to 18, characterized in that monitor or video panel, television, video glasses or head-worn display is selected for feedback.

Device according to one of claims 12 to 19, characterized in that the central system is constructed as a two-monitor system (user-monitor, trainer- monitor), either as a two-PC system (communications, RS232, TCP/IP) or as a one-PC system with the use of internal connections (DDE, TCP/IP). INO 0

21. Device according to one of claims 12 to 20, characterized in that the C portable system contains portable computers, body-worn computers, palmtops or play stations.

22. Biofeedback method for detecting and influencing of neurological and neuropsychological states of a user, including the steps of: oo a) determining and storing data representative of initial neurologic and Sneuropsychologic states of a user and interaction thereof with other physiological c systems of a person, based on an evaluation of electroencephalograms, event INO related Potentials and/or other polygraph-detectable signals such as in vertical C electrooculograms, horizontal electrooculograms, electrocardiograms, said determination being carried out using a central unit having associated hardware and software configured for neurological and physiological signal recordal and processing, and data evaluation and storage required to effect said determination; b) based on data obtained in step creating a user-specific profile and deriving therefrom, using the central unit, a user-specific training protocol having initial set-up parameters and target parameters; c) configuring portable units with the user-specific training protocol, the portable unit being arranged for neurological and neuropsychological interaction with the user; d) conducting a user-training session at the central unit and/or the portable units, during which the user carries out activities that influence one or more neurological or neuropsychological states; e) recording of neurological and neuropsychological responses during the user-training session and evaluating data associated with said responses at the portable unit; f) adaptively changing, as required, the initial set-up parameters of the user-specific training protocol as a function of the evaluation step and the target parameters of the user-specific training protocol; g) storing of data recorded during the user-training session at the central unit; and h) validating, at the central unit, of the user specific profile using signal-analytic methods and statistical comparisons with the initially recorded neurological and neuropsychological states of the user and/or a standard C collective. U

23. Biofeedback method according to claim 22, wherein the event related Potentials are evoked Potentials that are detected through visual, acoustic and cognitive stimulation, and wherein evoked Potentials are incorporated in the oo 00validation of the user-specific profile. (NO S

24. Device for carrying out the method according to claim 22 or 24, wherein o the central unit and the portable unit are outfitted with a communication system Sarranged to enable data transfer between the units, and wherein the central unit includes a polygraphic device and means by which the duration and capability of combining feedback trials of interstimulus intervals (ISI) and process is selected variably and individually, a profiler decision reinforcement device being integrated in the central unit.

Device according to claim 24, wherein the central unit and the portable unit contain interfaces for internet and/or other telecommunication protocols.

26. Device according to claim 24 or 25, wherein the central unit and the portable units contain devices for visual, acoustic and/or cognitive stimulation of a user. DATED this 14th day of December 2006 ELDITH GMBH WATERMARK PATENT TRADE MARK ATTORNEYS 290 BURWOOD ROAD HAWTHORN VICTORIA 3122 AUSTRALIA P22779AU01 L