Galileo System

Operator Manual

EP_NT
Evoked Potentials for Galileo NT Line

PROGRAM FUNCTIONING
SECTION

B8300031001
Rev. I
(BOOKLET)

0051

EDITION:

September 2011

EBNeuro
-FLORENCE-
ITALY
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INTRODUCTION

THE GALILEO NT LINE ENVIRONMENT

Galileo NT Line provides a structured environment for the management of several

kinds of neurophysiological testing, like electroencephalography and
polysomnography, evoked potentials, electromyography, etc.

The main component of the Galileo NT Line environment –the Database Manager
–is common to all the examination types, while each kind of testing is managed
by a specific application within the Galileo NT Line framework.

This allows achieving an overall optimization, which leads to an unparalleled

flexibility and modularity of all the Galileo NT Line systems.

Evoked Potentials testing is performed through the EP_NT software, which is

automatically invoked from the Database Manager whenever the user chooses to
record or to review an EP trace.

This program allows to set all the acquisition parameters (i.e. sensitivity, filters),
to program the stimulators (audio, pattern reversal, flash, electric, etc.), and to
collect the EP data from the patient. The same program can then review and
analyze the acquired data.

Introduction 1
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CHAPTER 1

QUICK START

1.1 GENERAL
Galileo NT Line is an EBNeuro product prevalently designed to acquire and
process biological signals (and store, display and print them at a later stage).

In particular, the program has been designed to manage encephalic signals.

At a "patient/registered data" management level, the system employs a new and

efficient database, based on SQL Firebird 1.5X. Its points of strength lie in the
solidity offered when accessing/exchanging the data on the network, in its safety
in terms of privacy, in the user-friendliness of its user interface and in the speed
with which queries can be performed within large databases.

The data connected to each patient of the database are generally divided into:

• Traces (or Recordings ) • Patient Reports or Histories

• Sub Recordings • Trace Reports
• Analysis • Comments
• Exams

In terms of Evoked Potentials, the smallest "unit" managed by the Galileo NT

Line database is the "EP Trace" that contains all the EP recordings performed
within a single session. The EP Trace can be divided into a series of "acquisitions"
called Sub Recordings, which individually correspond a specific acquired EP
potential (e.g. former SEP, BAEP, VEP, P300, CNV, etc.). The user can define
the start and the end of a session and continue the acquisitions on the same trace
or create a new EP trace.

An "EP Exam" is instead an aggregation of data connected to the same patient,

which contains both traces and (generally) images (TAC, MR).

The EP_NT traces management software is automatically started when the user
creates a new EP exam ("EP EXAM") or "recalls" an existing one (the EP_NT
software will be loaded also for similar recordings like "ERP EXAM").

The sections below briefly describe the steps that have to be performed to be able
to immediately use the EP_NT software in a correct manner.

Quick Start 1-1

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made available by Galileo NT Line's analysis (this is important in particular in the

ambit of clinical research).

Fourth section : the last option allows to exit from the EP_NT software and return
to the manager of the Galileo NT Line database (Exit).

NOTE

EP traces can also be saved and loaded by right clicking any point of the Traces
area. The pop-up menu that displays contains some of the main commands used to
manage traces.

NOTA

In case of double-side exams, if Save command is executed during only one side
visualization, only this side is saved. If Save command is performed during
Compare modality, both sides are saved as an unique exam.

2.2.2 TRACES MENU

This menu displays all the options that enable to display the traces within the
Traces window. This menu is divided into the "submenus" described here below.

2-4 Screen Organization

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ERP/CNV

The selection of this type of examination will display the “ERP/CNV

stimulation” window. To select the S1 and S2 stimulators (along with the related
parameters), it is sufficient to click buttons “…” in the ERP/CNV stimulation
window. Parameters ITI (Inter-Trial-Interval) e ISI (Inter-Stimulus-Interval) can
be set using the related controls provided.

EP Trending

The selection of this type of examination displays the “EP Trending stimulation”
window. The use of a neurophysiological monitoring (for example during surgery)
enables to accurately detect the temporal trend of some characteristic parameters
that the surgeon requires to diagnose potential cerebral disturbances. The
monitoring of the potential evoked signals usually takes into account the variation,
in terms of latency and amplitude, of the first two components found on the trace
(that are taken as reference model or template, for example N20-P25) and
compared it with the "base" evaluation attained at the beginning of the monitoring.
It is possible to monitor up to a maximum of 4 channels and set an alternate
stimulation in order to allow the operator to decide which channels have to be
assigned to one stimulus or to both.

3-8 Managing Preset

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3.2.9 EEG/EP

The control allows to manage the alternate EEG/EP monitoring. You can establish
how often it switches from one type to another exam.

3-10 Managing Preset

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3.5.1 ELECTRIC STIMULATOR (SOMATOSENSORY)

It is possible to manage in the same time two stimulators, if the installed hardware
allows it. In this case, on the left, there will be the buttons to choose the stimulator
which is being configured. It is possible to set, for each of these, the duration of
the impulse (expressed in μs, in an overall range of [5,1000] with steps of 5 μs)
and the stimulation frequency ( Rate in ms, in an overall range of [100,10000],
with steps of 1 ms).

The level of intensity of stimulation ranges from 0.0 to 100 mA. For electric
stimulation, it is also possible to control directly the stimulation (see Lower
TOOLBARS in the previous chapter).

In order to create dedicated presets both for upper and lower side stimulation
(which have different sensitivity), a configurable "current safe" limitation is
available in this tab: Minimum and Maximum intensity stimulations and step
variation are configurable.

Managing Preset 3-19

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3.5.2 ACOUSTIC STIMULATOR

In the left side of the window, the user can select the mode for acoustic
stimulation: Click and Tone.

The selection of these options allows to enable respectively the "Click" and
"Tone" sections.

3.5.2.1 Tone

The waveform that contains the tone (or tone envelope) can either be Linear or
Sinusoidal. The user must also configure the following parameters:

Frequency [Hz]

[250, 500, 750, 1K, 2K, 3K, 4K, 6K, 8K]

Plateau [ms]

it corresponds to the duration of the stimulus and is within the [0, 200]ms range,
with 1 ms steps.

Rise Fall [ms]

It corresponds to the envelope (linear or sinusoidal) of the tone signal, that is to

the rise and fall time of the tone. It can be value within the range of [0,100] ms,
with 1 ms steps.

3-20 Managing Preset

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The figure below show a tone with sinusoidal envelop by way of example.

3.5.2.2 Click

The parameters that need to be set in Click mode are the Duration of the impulse
(in a range of [50,1000] μs, with 10 μs steps) and the polarity (Compressed,
Rarefied or Alternate).

3.5.2.3 General

Section General on the right side enables to set the stimulation rate (Rate, in a
[10,1000]ms range, with 1 ms steps) and the Level of the stimulus (in a [0,132]dB
SPL range with 1 dB steps).

For acoustic stimulation, it is also possible to control the stimulation level directly
(see Lower TOOLBARS in the previous chapter).

Managing Preset 3-21

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3.5.2.4 EARPHONE

Section Earphone determines the mode by which the stimulus is presented to the
headphone, with or without masking noise. This section offers also the possibility
of setting all the possible combinations for Noise and Signal for each acoustic
channel. If the masking noise is used, there will be also another section in which
the user can select the intensity in dB SPL ([-40,+10]dB range with dB steps) of
the masking noise compared to the stimulus.

Another facility is to allows also pneumatic earphones: in this particular case the
delay due to the propagation of the sound in the air is calculated by the insertion of
the aero-tube length, by the dedicated control. The applied used formula is the
following: the rate propagation of the sound in the air is equal to 340
meter/second. With this new value ( which is the real transmission delay) we are
able to synchronize as well the trigger of the signal in order to obtain standard
evoked acoustic potentials.

3.5.2.5 BAEP

Section BAEP is used for "BAEP Waterfall" EP examinations (see sections

above). It enables to determine the number of decreasing steps that need to be
acquired (from a minimum of 2 to a maximum of 9). It's also possible to set the
step dimension of waterfall (in dB SPL) within this set: [5, 10, 15, 20] dB.

3.5.2.6 Test

Button Test enables to active stimulation example every time the settings are
changed.

3-22 Managing Preset

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3.5.3 FLASH STIMULATOR

The user can set the stimulation Rate (in a [20,1000] ms range with 1 ms steps)
and the Pulse Width (in a [1,20]ms range with 1 ms steps).

Managing Preset 3-23

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3.5.4 PATTERN STIMULATOR

This tab allows to set and change the parameters related to the Pattern stimulation.

There are two independent Frames for the stimulation, which can be selected by
means of the related check box.

The window is mainly divided into two parts: the left part refers to the pattern
stimulation mode, while the right one displays the tools that can be used to create
and display a preview of the pattern stimulation frames.

A pattern stimulation is generally a stimulus whose average luminance remains

unaltered in time.

Luminance can be briefly be regarded as the component of the video composite

signal that contains information on the black and white signal of the TV screen.
Average luminance influences the form of the response evoked by the potential
and more specifically the amplitude, producing significant differences on the
latencies of the response peaks. The first increases while the second decreases as
the average luminance increases. For this reason, it is very important to make sure
that the average luminance is calibrated accurately. The electronic controls on the
monitor are usually non linear while the contrast introduces variations in terms of
luminance.

Parameter Contrast is a control that is displayed on the left side of the window
and is defined by the following formula:

Lmax − Lmin
Contrast =
Lmax + Lmin

3-24 Managing Preset

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Where Contrast is the contrast and Lmax and Lmin the maximum and minimum
luminance. For the control, it is also possible to set a percentage contrast as
compared to the defined contrast, with a variation ranging from 10% to 100% and
variation steps of 10% (respective range [1,10], with 1). Another important
parameter is the Distance of the visual stimulator of the patient, which is
expressed in cm and has a range that can be set between 70 and 170 cm. To obtain
a correct stimulation angle (and the related spatial frequency) it is also necessary
to set the Screen size for the screen used in the pattern stimulation.

Monitor Dimension [inches "] Distance [cm]

13 94,59
14 101,87
A

15 109,14
17 123,70
19 138,25
21 152,80
Squares
Visual Angle [']
H V
15 64 48
B

30 32 24
60 16 12
90 10,66 8

Note Pattern Monitor Resolution has been fixed as 640x480

Table above describe as well standard Visual angles (B) which are use in clinical
visual stimulation protocols. For each visual angle the table will shows one
possible configuration by taking into account all elements of the equation (A)
(e.g.: pattern monitor dimension, patient distance, etc.).

In order to give an additional quick help, four main standard visual angles are
available ( after the selection of the relation monitor dimension) on the dedicated
"predefined angle" section.

Parameter Angle varies according to the distance and the size of the screen.

Managing Preset 3-25

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Spatial frequency is also a parameter that depends on other parameters (Distance,

Screen Size, Angle). It is expressed in cycles per space unit, where the space unit
is represented by a view angle.

Parameter Rate corresponds to the stimulation frequency. It indicates the

frequency with which the stimulation frame changes. It can be set within a range
of [100,10000) ms with steps of 1 ms.

Select check box Mask: to apply to the frame to display a circular mask so that
the fixation area of the pattern stimulation can be reduced.

Select Fixation point: to decide whether to display or hide the fixation point. This
point can be resized and positioned in any point of the screen.

The other sections on the left of tab Pattern of stimulators are related to the
Trigger and Stimulation.

3.5.4.1 Trigger

Select parameter T to generate a trigger every time the same frame (for example
for alternate stimulation with two independent frames) is displayed. In this case
the trigger is generated for every pattern stimulation period. If T/2 is selected, the
trigger will be generated for each frame change, equivalent to half of the
stimulation period.

3-26 Managing Preset

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3.5.4.2 Stimulation

Set mode Reversal to display only the frame A. The stimulation frequency is
related only to the frame that will alternated with its opposite.

Set mode Alternate to perform the stimulation by alternating the two frames A
and B defined by the operator.

In Alternate mode, any eventual change of palette colors into a frame (A or B) will
automatically impose the same palette color in the other one.

The right side of tab Pattern is related, as explained above, to the building of the
frame/s that will be used in the actual stimulation phase.

The larger pane provides a preview of the screen that will be used (as with graphic
editors) to draw the figure with the tools around it.

The screen can be divided in several ways by selecting the drop-down menu in the
upper left of the Preview window. Possible configurations are:

- Full corresponds to the full screen, which means that the screen is not divided
into sections.

- Midfield X and Y respectively indicate the vertical and horizontal partition of

the screen.

- Quadrant offers the operator the opportunity of dividing the screen into four
parts.

At this point, it is possible to change the division into quadrants or half-screens by

press the button with the arrow symbols .

The system displays in the preview one (or two) red bars that delimit the selected
section. The bar can be dragged by pressing the mouse pointer.

If the fixation point is enabled, it is also possible to move the read point with the
mouse to any position on the screen or resize it.

Managing Preset 3-27

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The fixation point can be moved to a specific location on the screen, exactly in the
center of the quadrants or of the screen itself. To do so, it is sufficient to select the
related option in the pop up menu that displays when the right button of the mouse
is clicked on any area of the screen.

A graphic bar, divided into several parts, displays above the Preview window.

The drawing tools is represented by four icons, each representative of a typical

morphology, like full screen, chessboard, horizontal and vertical bars. The full
screen configuration prevents the color inversion from being applied during the
stimulation phase.

If the sinusoidal icon is selected, the variation of the colors in the pattern will have
a sinusoidal shape (only in grayscale, the palette color is disabled in this
situation), passing from the first to the second color instead of being distinctly
separated (this applies only to bars and strips).

The user can also use a palette by selecting the bucket option.

At this point, the system enables the vertical menu bar where it is possible to set
two colors from sixteen available. Checkbox Inv enables to invert the
combination of colors set while checkbox Σ creates a specific color resulting from
the average of the two defined ones.

3-28 Managing Preset

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NOTE

The table below refers to the real matching between timebase and sampling rate.
These parameters are useful only in case of devices which uses raw data modality:
BE and BE Light families. Other old headboxes does not support completely this
table.

Sampling Rate [Hz]

BE/BE LIGHT
128 256 512 1K 2K 4K 8K 16K 32K
1 ▲
2 ▲ ▲
3 ■▲ ▲ ▲
5 ■▲ ■▲ ▲ ▲
7 ■▲ ■▲ ▲ ▲
10 ■▲ ■▲ ■▲ ▲ ▲
20 ■▲ ■▲ ■▲ ■▲ ▲ ▲
Time Base [ms]

30 ■▲ ■▲ ■▲ ■▲ ▲ ▲
50 ■▲ ■▲ ■▲ ■▲ ■▲ ▲ ▲
70 ■▲ ■▲ ■▲ ■▲ ■▲ ▲
100 ■▲ ■▲ ■▲ ■▲ ■▲ ■▲ ▲
200 ■▲ ■▲ ■▲ ■▲ ■▲ ■▲ ■▲
300 ■▲ ■▲ ■▲ ■▲ ■▲ ■▲
500 ■▲ ■▲ ■▲ ■▲ ■▲ ■▲
700 ■▲ ■▲ ■▲ ■▲ ■▲
1000 ■▲ ■▲ ■▲ ■▲ ■▲
2000 ■▲ ■▲ ■▲ ■▲
3000 ■▲ ■▲ ■▲
5000 ■▲ ■▲
■ Available configuration only for BE family devices
Legend

■ Default configuration only for BE family devices

▲ Available configuration only for BE Light family devices
▲ Default configuration only for BE Light family devices

The Delay option enables instead to set a maximum of 5DIV (in partitions of the
time base) in pre and post trigger in the traces window. A vertical bar displays to
indicate the exact time when the trigger event occurs, if this function is enabled.

3.2.2 AVERAGE

The Average section allows to set the values of controls like the Preset and the
possible Rejection level related to the amplitude of the acquired signal. In
addition, for standard EP exams (like acoustic, electric, visual exams) there is the
possibility to manage differently the odd traces respect to the event ones. In order

Managing Preset 3-3

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under exam. This function is available when the stimulator is indifferent to the
choice of the side. In other words, during a VEP Flash, the user covers one of two
eyes of the patient, whereas the system will supply always the same stimulus. You
should only recorder, for each trial, the under test side. In the macros in which the
system supplies different stimuli according to the side (for example in BAEP, in
which the earphones stimulate the left or the right side), it is necessary to select
the Double Macro checkbox and to indicate in the drop-down menu of the
compatible macros, the macros for the next side under test.

3.2.7 EXAMINATION

The sub-window Examination allows to select the type of recording for the
evoked potentials that have to been performed.

The system displays a series of standard recordings like Acoustic, Somatosensory,

Visual, BAEP Waterfall and other types of recordings that requires the
configuration of additional parameters in function of the stimulation that needs to
be performed, for example P300, CNV, ERP/CNV and EP Trending.

NOTE

Particular examinations will be described deeply in separated chapters:

• Chapter 6: EP Trending
• Chapter 7: P300, CNV, ERP/CNV

There is also the possibility to manage as well any eventual external stimulator
(use in this case the External examination).

In the latter only a sub-window named Stimul. will be displayed above the
Examination, showing additional controls.

The sections here below provide a brief explanation of the types of examinations
available:

Acoustic/Somatosensory/Visual

These are "standard" examinations. The selection of these options does not
significantly affect the remaining parameters (as the type actually depends on the
stimulator used) but is required and used only for classification purposes (within
the database management).

3-6 Managing Preset

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3.2.8 SPLIT SCREEN

The sub-window Split screen enables the operator to reduce, both in run and
replay mode, part of the Traces window while leaving unaltered the sensitivity on
the remaining part of the screen. This tool is useful for acquired potentials that are
known to have a high amplitude in the first milliseconds from the stimulus, and
for which the response of the following milliseconds, with a lower amplitude, is
far more important. This tool enables to correctly select the sensitivity on the basis
of the desired potential amplitude without the visual disturbance that is typical of
a high initial response.

The figures below show an example (that is purely indicative) of a trace before
and after the enabling of option Split screen.

The Traces window displays a vertical hatched bar to indicate the temporal
separation between the current sensitivity (on the right) and the attenuation (on the
left).

Managing Preset 3-9

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CHAPTER 7
COGNITIVE EVOKED POTENTIALS

7.1 THE P300 PROTOCOL

7.1.1 GENERAL

The P300 (P3, Late Positive Component) response has been associated with a
variety of cognitive activities, including decision making, signal probability,
attention, discrimination, uncertainty resolution, stimulus relevance, and
information delivery. In fact, so many cognitive events have been related to P300
and other late waves. If one were to look for a common factor to which the various
cognitive activities associated with P300 were related, it would be the information
processing (Donchin et al., 1983).

P300 is an electrophysiological response which appears at the end of a complex

cognitive elaboration sequence by the evocation of a stimulation paradigm and the
periodic presentation of the "expected" stimulus signal.

Standard literature use the terms Frequent for the standard stimulus, and the label
Rare for the random expected stimulus, which evoked the P300 potential.

The Latency of this potential is then the evaluation of the time occurred for the
patient in order to finalize the complete detection of the expected stimulus,
whereas the Amplitude depends of a probability of appearing (both objective and
subjective) of the stimulus and also "how many information" does it transmit at
the patient.

NOTE

It’s important to verify that the patient has been understood the task to do (to
ignore the frequent stimuli and to detect the rare stimuli), because the P300
response requires a complete collaboration of the patient.

7.1.2 STIMULATION

The P300 component is widely independent to the stimulation modality, and it can
be obtained by using acoustic, visual or somatosensorial stimuli inserted in many
different stimulation paradigms.

For a "clinical use", the more simple stimulation paradigm used is the "OddBall"
paradigm, which is generally carry out by bi-aural acoustic stimulation.

Cognitive evoked potentials 7-1

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The standard montage include three electrodes placed on the median line of the
head (Fz, Cz, Pz - using 10-20 system reference position), referred to a bi-
auricular electrodes, with the additional channel which is used for the ocular
rejection (EOG).

Cognitive evoked potentials 7-3

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By subtracting "off-line" the result attained for the Rare stimulus from the one
evoked by the Frequent stimulus, you attain a negative value, the so-called
Mismatch Negativity MMN (typically present for acoustic stimuli).

This value is not affected by the attention performance and can therefore be used
to study the memory and discriminate stimuli. It can be calculated using through
section Tool.

7.2 THE CNV PROTOCOL

7.2.1 GENERAL

Steady Potential Shift (SPS), is the Contingent Negative Variation (CNV), first
described by Water, Cooper, Aldridge, McCallum and Winter (1964). The CNV
may be observed when subjects are told that they must respond to an event some
time after a warning signal is given.

One type of SPS, the CNV, has been found maximal over the central cortex and
less pronounced at frontal and parietal areas (Cohen, 1969). Simson et al. (1977)
confirmed that the later segment of the CNV is localized primarily over the central
cortex. Delineation of CNV generators is very complicated because these slow
negative potentials have contributions from sensory, motor, and association
cortex that vary in relative magnitude according to the nature of the stimuli, the
task, and motor response requirements. Large slow potentials (greater than 10 µV)
have electrical sources mainly in extended cortical regions. Sub cortical neurons
may contribute to activity measured at the scalp, but they account for only a small
part of a response. However, generators that are capable of triggering widespread
Cognitive evoked potentials 7-5
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cortical activity may be located in sub cortical areas (e.g. thalamus or other brain
stem areas).

Typical method for obtaining CNV involves the presentation of a Warning

Stimulus (S1), followed within a fixed time period (Inter Stimulus Interval, I.S.I.)
by a second Conditioning Stimulus (S2) to which the subject responds. The S1
may be a light, S2 may be a tone. The interval between S1-S2 might be 1,5 sec.
The CNV is maximally recorded with a scalp lead at Cz (vertex) with an
appropriate reference site. An important consideration in the measurement of
CNV is the time constant (TC) used. The TC should be long with respect to the
physiological event being recorded.

One suggestion is that the TC should be three time the S1-S2 interval.

The CNV may be obtained by averaging of 6-12 combinations (trials) of S1 and

S2. Electrical potentials produced by eye movements and blinks are possible
sources of contamination on ERPs, especially the CNV. The measurement of these
potentials and exclusion of contaminated trials produces satisfactory results.

NOTE

It’s important to verify that the subject has been understood the task to do,
because the CNV response requires a complete collaboration of the patient.

NOTE

The CNV protocol does not work with MYTO device and NeMus 2 device. The
Pattern stimulator is not available with this type of exam.

7.2.2 STIMULATION

The CNV component is widely independent to the stimulation modality, and it can
be obtained by using normally acoustic and visual stimuli inserted in many
different stimulation paradigms.

For a "clinical use", the more simple stimulation paradigm used is the "standard"
paradigm, which is generally carry out by bi-aural acoustic stimulation and visual
flash stimulation. CNV "standard" paradigm:

I.T.I I.S.I
Stimuli
[ms] [ms]
Stimulation Specification

6500 1500 W Flash 10 ms pulse

Tone 1000 Hz, 100 ms Plateau, 10 ms Rise/Fall, 500
C Acoustic
ms Rate, 65-70 dB HL intensity

7-6 Cognitive evoked potentials