Screening questionnaire

in this lecture we're going to talk
about the screening questionnaire for
non-invasive brain stimulation and such
a questionnaire is necessary to
determine inclusion or exclusion of the
study and it's mostly focused on a
safety screening if this is appropriate
for your
participant now when we're talking about
participant screening for most of our
studies we're looking at healthy
volunteers and we aim for editable risk
that means that if you are focusing on a
patient population the screening
questionnaire will probably be very
different if you are not sure as an
experiment how to respond or what
decision for inclusion exclusion to make
and based on the answers to such a
questionnaire I would always recommend
to consult others for example at dondis
Institute in the Netherlands we would be
ourselves or we would ask the certified
experimentor that's always present there
is an experimental consultant somebody
who trains others for certification and
there's even an Institute consultant at
the very top level with uh expert
knowledge on safety screening and
inclusion but most importantly and this
is the recommendation uh that everybody
should adhere to when in doubt simply
don't proceed people are very
understanding if you explain to them
that based on that risk assessment you
wouldn't continue with the study and if
there are delicate matters or uh there's
a personal or medical
history we would U often explain that
unfortunately we cannot continue with
this study you do not need to go into
the details on why that decision has
been made as long as we maintain aable
risk safety definitely does come
first in today's lecture we be looking
at the screening form for uh that we've
developed for non-invasive brain
stimulation at The donders Institute and
this is a form and here you see the top
of it that we would often administer
after the participant has signed the
informed consent namely we're asking
about quite some private and medical
history so this is often also best done
either individually or in a private
space where you can consult with the
participant one onone please take the
time for this and make sure that people
are completely free in giving their
answers and all your important details
the safety is dependent on participants
being able to answer fully and
honestly we'll be going through all of
these questions from top to bottom and
actually there are more coming after
number eight but the top that you see
here uh if somebody answers yes to them
then there is no other option than to
exclude that participant from the study
do not continue with the participation
and we'll be going through them at the
top and bottom some are very boring so
are you younger than 18 years this is
what we would use for Ultrasonic
stimulation for MRI the threshold might
be at 16 that has to do with both
knowledge and safety and participant uh
Insurance same thing if you're pregnant
or you think that you are uh we would
simply retain anable risk and there
isn't a well enough evidence for the
safety during pregnancy that also holds
for the certified experiments though we
simply say we do not have evidence that
it is risky or unsafe nonetheless we are
simply not continuing because we would
like to maintain inable
risk um the have you ever had a brain
surgery is a no-o because it's much more
difficult to predict on any of the
changes or the skull structures or if
there are still electrode leads in place
but uh if these are your patient
populations your questions of course
will be quite different similarly a
cardiac pacemaker or inter cardiac lines
aren't contraindications for TMS as such
per se if TMS is far enough away from
these devices there is definitely in
editable Risk but in the healthy
population we simply exclude it it's um
a much more straightforward the same for
an implanted neuros stimulator or for
cckar implants in your
ears um when we ask about a medic iCal
infusion device we're for example
thinking about an insulin
pump and that longer list of all these
devices there's no evidence that it is
unsafe but we are better safe than sorry
and for ultrasound specifically the
safety characterization isn't complete
yet ultrasound wasn't considered as a
potential treatment when all of these
medical devices and implantables were
developed we also currently take a
cautionary approach for
epilepsy in some other lectures were
highlighting that there's no known risk
of epilepsy for ultrasounds nonetheless
we're copying this from transum magnetic
stimulation because at this early stage
this foundational stage in the field we
are taking a a cautious approach but we
do expect that this will be changing in
the
future so for all of these questions if
you answer any of them yes we do not
continue with the participation in the
experiment and that's also important to
not simply copy these questions from one
Institute or from one study to the other
because with a different population and
and a different goal intended target you
might actually have a different
exclusion
criteria but we'll now move on to
questions that are more open-ended in
nature we still ask for yes or no but we
often also ask in an interview between
the experimenter and the participant
um about more details to allow us to
make an informed
decision so we already exclude people
with a personal history of epilepsy we
also ask about close relatives a parent
siblings children uh whether they had
epilepsy or maybe convulsions or
seizures we are
excluding uh close relatives with
epilepsy such as your parents or your
siblings but epilepsy is often
misunderstood um or or even misdiagnosed
if you have a single seizure maybe
because you had a high fever when you
were a baby that's not the same thing as
having epilepsy therefore we ask about
this and somebody says oh yeah my
brother has epilepsy and we ask more can
you give us details and they say yeah he
had a seizure when he was uh 4 years old
or two years old uh then then we can
make the informed decision ah okay that
is probably a one of event that isn't an
diagnosed epilepsy and we are not
relying on the Layman reporting of some
naive participants but we're relying on
our expert uh knowledge and that does
require some medical background on these
risks that's also why we say if you're
unsure ask an expert or do not
proceed similarly have you ever ever had
hot trauma uh that was diagnosed as a
concussion or associated with a loss of
consciousness and when because many
people had have had a concussion but
sometimes that's 10 years ago we have at
the Don Institute a threshold we say we
want the concussion to be at least 6
months ago and the participant to be
fully recovered at least 3 months the
effects of a concussion can last a
little bit longer and sometimes you say
yeah I had the concussion a year ago but
they also want to make sure that the
people are fully recovered once they are
starting and effect can be very
longlasting
um we're asking if people are prone to
faint that's not specifically a
contraindication uh but that's also why
we're asking about the circumstances
when that is happening TMS ultrasound T
doesn't lead to fainting directly but if
somebody says yeah I often get anxious
in small rooms uh or when I don't eat or
drink enough uh we are well prepared in
that case and we can even have water
ready or food or we say well maybe this
isn't the best experiment for you to
participate because we cannot make the
lab any
larger we are asking about a diagnosis
of neurological and pyretic disorders
we're asking for a diagnosis rather than
a
self-report but this isn't a heart
exclusion criteria if we say healthy
participants we don't mean anybody
without any diagnosis there are many
healthy participants who do have a
diagnosis for example of ADHD and they
might receive
medication um or they might have been
diagnosed with
depression earlier but it is critical
that we ask for more information here if
you're doing an attention study you
might want to exclude people with a
diagnosis of HD HD but not if you're
doing um um for
example an a resting state study because
you might want to have an normal
distribution of your population and that
means that some people are on different
aspects of that
Spectrum for depression we would often
ask when the last episode is and whether
they are receiving medication and
whether that medication is stable or
whether they're currently undergoing
treatment in plastic changes when
medication isn't stable or they're
currently in an episode or with rapid
changes uh it might not be relevant to
include them as a healthy participant
similarly where the depression can be
severe or um severely de
debilitating you can see that this is a
critical but also a difficult question
many many of our prospective
participants might have an diagnosis ad
ADHD depression anxiety these are very
very common and we don't want to
completely exclude them upfront but we
do want to make an informed decision
about the severity or the current state
of these um um psychiatric
disorders now we ask about Metal in the
brain skull or elsewhere in the body um
rather than having a hard no we would
say if there's metal in the brain and
skull we we wouldn't continue with these
participations but sometimes people have
a Clips vascular Clips or fragments um
from an accident uh if that is close to
where we're intending to stimulate we
probably wouldn't continue but sometimes
it's in their knee and your stimulating
their head and there isn't the problem
at all that's why we ask for the type of
metal and the location uh some people
will be reporting metal in their uh
mouth for example and that's why we ask
if it's metallic or magnetic
even um we're asking about hearing
problems um there is evidence that if
you have ringing in the ear such as
tenius and you receive a loud click as
with TMS or sometimes with ultrasound
the ringing can temporarily get worse or
if you're highly anxious the or tired
the ringing might fluctuate uh it's
important to know this both when you're
doing a hearing experiment and itional
experiment but also for the safety we do
not want to induce ringing in the ears
for a longer term that's why we ask
about this and we can also be well
prepared when we're
starting we're asking about skin
particularly eczema or other skin
energies because this might be a place
where we are intending to couple or
electrodes or or ultrasound
transducer we would avoid that um but
we're only asking about hands or head uh
because this is where we could place the
electrodes for electr myography or the
head where we are
coupling um it's important that we don't
over askk there are many other parts of
the body where you can have a skin
disease or allergy that we do not need
to know about because we're not even
stimulating there and therefore if
you're not intending to place any
electrodes on the hand also don't ask
for it or the other way around
obviously there isn't any evidence that
ultrasound would interact with XMR or
could worsen it uh but there are
suggestions that uh peripheral
stimulation can lead to skin irritations
or redness so better safe than
sorry we ask about uh brain stimulation
experience and here it is critical that
we ask when this has happened if there
were any problems and this is a catchall
question because if there were any
problems it's better that we are
prepared for this we might even say oh
wow you had excessive pain from or
unexpected expressive pain from TS or
ultrasound perhaps we shouldn't do this
again um we're also asking because we do
not want any interactions between
ongoing studies imagine that you have a
plasticity inducing protocol for TMS on
Monday and on Tuesday you come in for an
ultrasound experiment again to induce
plasticity these might compound and
instead we would like to have at least a
weak spacing between them and similarly
we would often ask how many sessions
they've participated in the past month
Jo also make sure that there are not
being um uh any possibilities of
confounding interacting or uh
accumulative effects of brain
stimulation there's a lot of details
that we need to ask if we have very
recurring
participants and some of the critical
aspects for us are whether the
stimulation is part of a therapeutic
dose but we would never have any
interaction sessions whether there's a
plasticity induction again we wouldn't
stimulate uh in the week after any
plasticity induction even if it's only
very short session or whether these are
single pulses either ultrasound or uh
TMS because then um we only wait
generally a day or
three we ask about MRI if we're making a
scan we it's helpful to know if people
are claustrophobic for example we can
recommend or can be prepared for this
assessment uh and we're asking for
prescribed medication only in the past
two weeks because there can be a very
large Medical um history and whether
they're part in any type of treatment or
or research we do not need to know uh in
generally about
contraceptives um we do ask about the
prescribed medication only overthe
counters are often at inable risk and
some medications are intermediately
prescribed or somebody might report I am
using a Chinese herbal tea and if we do
not know what type of psychoactive
substances are in it
if we do not know we unfortunately
cannot continue but many medications we
are able to look up what they are what
their effect sies if you have an
slightly first generation antidepressent
a tricyclic antidepressant that can lead
to a modulation of brain excitability
and we wouldn't uh use TMs especially
not an a plasticity inducing
protocol but um serotonin reuptake
Inhibitors selective uh serotonin reup
Inhibitors ssris uh their side effects
are much more
contained and they do have a good safety
profile in combination with TMS for
example so we can look up side effects
of medication in WebMD in many other
online databases and experts often have
an a complete list of safety Assessments
in the TMS safety consensus there is an
overview of possible interactions
between medication and stimulation that
is a fantastic uh resource to make an
informed decision
here we're also asking about
psychoactive substances or drugs uh that
are used in the past two days last 48
hours uh we would like to avoid many of
those interactions this is a
particularly helpful one to warn your
prospective participants about uh maybe
um you can warn them that isn't a
fantastic idea to participate in the
study shortly after they went to uh
party or uh had other
expectations it is especially important
that we're considering this for
potential
interactions and because we want to make
sure for your study quality that we have
a stable Baseline uh we don't want um
many subjects who haven't used anything
and some who've used this or used others
because then we're introducing a lot of
variability and there might be an
interaction especially for plasticity
inducing protocols the same holds for
alcohol we're we're asking about units
of alcohol and here um the unit is
internationally defined it's one shot of
liquor or one small beer Please be aware
if you're in the UK a pint already has
two units we're asking about the number
of units in the last 24 hours we don't
want to exceed this three units and that
isn't a lot especially if you're
including the student population so warn
your students ahead of time that this
can be a reason uh why they cannot
participate if they're drinking more
than three beers the LA the night before
they might not even feel uh intoxicated
yet we're not including them in the
study to make sure that we have a
completely stable Baseline for all of
our participants the same you is about
caffeine use in the last 12
hours it's not an exclusion criteria per
se but somebody says oh I usually drink
um 10 cups of coffee
and then that morning they come in
without they might even have withdraw
effects or the other way around if you
have multiple sessions of again for
plasticity inducing protocol you might
have your targeted intervention and a
control session and another control site
you want to make sure that you have this
stable for all of these sessions that's
why we're asking about it the same for
the amount of
sleep we're not asking how many hours
for some people 6 hours is more than
enough for others that's very short that
we asking if there was a normal amount
or maybe they might have been sleep
deprived and as you can see for all of
these questions there isn't only a very
clear yes no right if there's no on all
of them obviously you can participate if
there's a yes on one of them we will
have to ask about the details to make an
informed decision whether to continue or
not it is always the responsibility of
the researcher to do so and you can even
tell your participant if you get an
inkling that they are maybe very nervous
anxious or anything is off even though
they're not reporting it in the paper
you use all your expertise and insight
to make an informed decision do not
strictly adhere oh but they the answered
no if it doesn't feel right for you as
an experimenter something is off or
weird you can simply decide not to
participate that is always much better
than including noisy data points then
actually something going wrong or
somebody doesn't
disclose their condition and it might
have had a safety assessment later
on H it's important that we're aware of
how strictly some participants feel that
they really want to engage in the study
they want to participate they might be
very eager or ashamed if they cannot and
it is totally acceptable if we tell that
oh Unfortunately today the um experiment
cannot continue even because of
technical
failures it please put the safety of
your participant the safety to comfort
and uh their current state as a
priority um and when you're making these
informed decisions and remain aable risk
both for your data quality and for the
safety of everybody involved for now
thank you very much for listening to
this lecture