1、IEEE Recommended Practice for Neurofeedback SystemsSponsored by the Standards Committee IEEE 3 Park Avenue New York, NY 10016-5997 USA 29 June 2012 IEEE Engineering in Medicine and Biology SocietyIEEE Std 2010-2012IEEE Std 2010-2012 IEEE Recommended Practice for Neurofeedback Systems Sponsor Standar
2、ds Committee of the IEEE Engineering in Medicine and Biology Society Approved 14 May 2012 IEEE-SA Standards Board Abstract: A detailed set of documentation requirements is proposed. The detailed requirements for the documentation of neurofeedback instruments and software to provide quality and avail
3、ability of information to users are specified. Keywords: biofeedback, biofeedback assessment, biofeedback equipment, biofeedback instrumentation, biofeedback software, biofeedback training ,(neurofeedback, neurofeedback assessment, neurofeedback equipment, neurofeedback instrumentation, neurofeedbac
4、k software, neurofeedback training xThe Institute of Electrical and Electronics Engineers, Inc. 3 Park Avenue, New York, NY 10016-5997, USA Copyright 2012 by The Institute of Electrical and Electronics Engineers, Inc. All rights reserved. Published 29 June 2012. Printed in the United States of Ameri
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18、ined from the IEEE Standards Association. Copyright 2012 IEEE. All rights reserved. viParticipants At the time this recommended practice was completed, the Neurofeedback (EEG Biofeedback) Systems Working Group had the following membership: Thomas Collura, Chair Howard Lightstone, Vice Chair Sara Agu
19、el Michael Hoffman Cynthia Kerson Alan Pope Marc Saab Klaus Schellhorn Nancy Wigton The following members of the entity balloting committee voted on this recommended practice. Balloters may have voted for approval, disapproval, or abstention. Association for Applied Psychophysiology and Biofeedback
20、(AAPB) BrainMaster Technologies, Inc. EEG Education referring to operant conditioning process. amplifier: A device that draws power from a source other than the input signal and produces as an output an enlarged reproduction of the essential features of its input (Graf B5). analog to digital convert
21、er (A/D): A device that changes an analog signal to a digital signal of corresponding magnitude through discretization (Laplante B11). artifact: Any distortion of the electroencephalography signal from any physiologic source other than the brain or any non-physiologic source that may interfere with
22、the interpretation of the signal. average value (P-P): The “average value” traditionally used in neurofeedback is actually the “equivalent peak-to-peak” voltage value assuming that the signal being measured is a sine wave. The normal method of calculation is to sum the absolute voltage values of eac
23、h signal sample, divide by the number of samples, and 2 2 to get the peak-to-peak equivalent. baseline: Status of brain activity when not engaged in a feedback/operant conditioning process. characterization: The extraction of significant features from the EEG waveforms. client: Person who is receivi
24、ng neurofeedback (i.e., is connected to a neurofeedback system); person from whom electroencephalography signal is being acquired. clinician: Person responsible for ordering (prescribing) as well as interpreting and making clinical decisions about neurofeedback; oversees the neurofeedback session. T
25、his person is also responsible for the technician. coherence: Measure of phase relation of two processes at a specific frequency band (ACNS B1). Copyright 2012 IEEE. All rights reserved. 3IEEE Std 2010-2012 IEEE Recommended Practice for Neurofeedback Systems common mode rejection ratio (CMRR): A mea
26、sure of amplifier quality with differential inputs, defined as the ratio between the common-mode gain and the differential gain (Laplante B11). component: A major element of a neurofeedback system (acquisition, software, etc.). corner frequency: Frequency designating the meeting between the transiti
27、on band and passband; frequency at which gain crosses 3dB (typically) (Graf B5). digital filter: A linear computation or algorithm performed on a selected series in the form of an input signal that produces a new series as output (Graf B5). EEG activity/frequency bands (alpha, theta, delta, sensorim
28、otor rhythm, beta, gamma, etc.): There are many definitions for naming electroencephalography data bands. Typical names/ranges (from Fisch B4) are: DC-EEG: 13 to 30 Hz SMR (sensorimotor rhythm): rhythm seen in signals over the sensorimotor cortex; usually considered in the range 12 to 15 Hz gamma: 3
29、0 Hz (particularly 36 to 44 Hz) electroencephalograph (EEG): Instrument for recording the electrical potentials produced by the brain by the use of electrodes. event related potential (ERP): Evoked activity of the brain related to a sensory stimulus; derived by averaging electroencephalographic acti
30、vity with respect to stimulus onset. fast Fourier transform (FFT): Computational technique that reduces the number of mathematical operations in the evaluation of the discrete Fourier transform (DFT) to N log2N (Laplante B11); where DFT is a transform for Fourier analysis of finite-domain discrete-t
31、ime function; used to convert the input signal from time domain to frequency domain. finite impulse response (FIR) filter: A FIR filter is a non-recursive method for extracting frequency information from a time-sampled input. FIR filters typically have good phase accuracy but poor amplitude fidelity
32、. FIR accuracy is a function of the number of samples used. frequency response: (A) The portion of the frequency spectrum that can be sensed by a device within the specified limits of amplitude error (Graf B5). (B) The range of frequencies over which an amplifier responds within the defined limits o
33、f amplification or signal output (Graf B5). (C) Range or band of frequencies to which a unit of electronic equipment will offer essentially the same characteristics (Graf B5). haptic: Of, or pertaining to, a sense of touch; tactile. IIR (infinite impulse response) filter: An IIR filter is a recursiv
34、e method for extracting frequency information from a time-sampled input. IIR filters typical have poor phase accuracy but good amplitude fidelity. Copyright 2012 IEEE. All rights reserved. 4IEEE Std 2010-2012 IEEE Recommended Practice for Neurofeedback Systems joint time frequency analysis (JTFA) fi
35、lter: JTFA filters analyze data in both time and frequency domains simultaneously; this is done by segmentation of the time series into shorter epochs, the determination of the amplitude of the frequency of interest in each epoch, and the analysis of the time course of modulation of the amplitude of
36、 the frequency of interest (ACNS B1). operant conditioning: A form of learning or modifying behavior during which individuals modify their own behavior due to the consequences of that behavior. Neurofeedback uses responses based on electroencephalography data as the stimulus for the desirable reward
37、s (positive consequences). passband: Range of frequencies, or frequency band, for which a filter passes the frequency components of the input signal (Laplante B11). peak-peak voltage: The peak-peak voltage is twice the amplitude of the voltage being sensed/measured. For simple sine waves, the value
38、is easily determined. For complex electroencephalographic waves, an average value is computed and the peak-peak voltage is inferred from that result. phase: Angular relationship between two waveforms. product: The component(s) sold or provided by a manufacturer. quantitative electroencephalography (
39、QEEG): Mathematical analysis of electroencephalograph waveforms used to extract discrete data and output specified parameters. The electroencephalography data can be algorithmically analyzed by the size, frequency, and/or the locality of the electrical activity. These datasets can be reported either
40、 absolutely or relative to some other dataset. The data is typically presented in tabular form or as topographic maps. rolloff: Transition region between passband and stopband; usually reported as a function of logarithmic frequency in decibels per decade or decibels per octave. session: Single admi
41、nistration of neurofeedback to the client by the clinician or by the technician but overseen by the clinician. There may be multiple electrode placements and/or shaping actions within a single session. A neurofeedback regimen may necessitate multiple sessions. shaping: The use of significant feature
42、s of the electroencephalograph (EEG) waveform in the operant conditioning process to alter the EEG waveform. Shaping implies control over which elements of the transformed waveform are used and how they are applied in producing the operant conditioning stimulus. slow cortical potentials (SCP): A fee
43、dback signal generated from lowpass filtering of artifact-corrected electroencephalograph using a sliding averaging window. The frequency range is usually considered 0 to 2 Hz (Hinterberger B6, ACNS B1). stopband: Range of frequencies attenuated by a filter with some specified attenuation. technicia
44、n: Operator of neurofeedback system while the client is connected to a neurofeedback system. threshold: Term used to describe the setting of a point at which a transformed value is acted upon (such as artifact detection). wavelet filters: Wavelet filters use a computation method based on harmonic an
45、alysis rather than the Fourier transforms used by traditional filter methods. Wavelet filters can contain either finite impulse response or infinite impulse response filter banks. Copyright 2012 IEEE. All rights reserved. 5IEEE Std 2010-2012 IEEE Recommended Practice for Neurofeedback Systems 3. Gen
46、eral 3.1 Availability of information The information outlined in this standard shall be made available to the user in the documentation delivered with the product, in the marketing, in the training literature, or upon request. This should include but not be limited to the following: a) Detailed desc
47、riptions of the technology, functionality, and features b) Detailed instructions about installation, configuration, usage, and methodology c) Specifications of each component of the system d) Descriptive diagrams, images, and software screen captures where applicable to complement the instructions e
48、) Description of the hardware and software components as well as the use of the system, as a whole f) Information to aid in the detection of failures and understanding of the consequences of failures or misuse The details of each of the above points are contained within the subsequent sections of th
49、is standard. Guidelines for adequate user documentation are provided in Clause 9. 3.2 Regulatory requirements 3.2.1 Safety The manufacturer shall document the system adherence to the IEC 60601-1 Safety and Essential Performance standard B7.3Certification documentation of adherence to IEC 60601-1 (as recognized by the regulatory body within the country of sale) should be made available on request by the user. 3.2.2 Intended use The intended use of the system should be disclosed and should be consi
