Modulation of the Activity in the Cerebellum With Transcranial Direct Current Stimulation in Autistic Participants
Phase: NA
Conditions: Autism Spectrum Disorder
Sponsor: Beatriz Catoira

Information letter and informed consent for participants of
fMRI + tDCS experiments
1
Title of the study:
Modulation of the cerebellar activity with tDCS in autism spectrum disorder
patients.
2
Goal of the study:
You have been asked to participate in a study. Before you decide to participate, it is
important that you understand why the study is being conducted and what the study
entails. So please take the time to read the following information thoroughly and
discuss it with others if you wish. We are available to answer your questions or if you
require additional information.
With this study we want to delve deeper into the underlying brain mechanisms that
underlie understanding social events, as well as the influence of a brain stimulation
method on these brain mechanisms and social understanding. In addition, we will
measure brain activity over two visits via a MRI while you are performing a computer
task. During the measurements, after the brain stimulation, you will see different
cartoons describing different situations on the computer screen. You will have to put
the pictures in the right order. Afterwards in the next task, a face will be presented
and
you will have to judge which emotion was depicted. You will receive
questionnaires on those days.
Each visit will take approximately 2 hours. You will receive a compensation of 80
euros for this, at the end of the last visit. The examination takes place in a
department of the University Hospital Brussels.
3
Description of the study:
MRI scan
A brain scan or Magnetic resonance imaging (MRI) is a physical (magnetic)
technique that makes it possible to visualize brain areas. On the one hand one can
study the anatomy (shape) of the brain by means of MRI, on the other hand one can
also study important aspects of the functioning of the brain, such as brain blood flow,
oxygen and energy consumption.
Brain stimulation with tDCS
Brain stimulation is a technique that makes it possible to temporarily influence activity
in areas of the brain in living and conscious people. Using this, one can study
important aspects of the functioning of the stimulated brain parts.
Brain stimulation via transcranial direct current stimulation (tDCS) is a form of brain
stimulation that is widely researched. tDCS uses a weak current that is passed to the

brain through two electrodes (anode and cathode) placed on the scalp. The electric
current is "direct", so the current flows from the anode to the cathode, creating static
electric field. The direct current changes the excitability of the neurons. This can
continue for up to an hour after the end of the stimulation. In addition to the location
of the electrons, the choice of where to place the anode and cathode also plays a
role. At the neuronal level, we see that anodal stimulation causes a depolarization
that leads to an increase in excitability, while cathodal stimulation causes a
hyperpolarization that leads to a decrease in excitability of the neuron.
New to this research is that we want to investigate whether the way in which people
with an autism spectrum disorder process and understand social events can be
influenced by means of tDCS.
The expected total duration of the study is approximately 4 hours (two times 2
hours), of which 2 hours (twice 1 hour) in the scanner.
100 people will participate in this study (40 people with autism spectrum disorder
and 60 neurotypical (healthy) individuals).
4 What is expected of the participant?
For the success of the study, it is extremely important that you cooperate fully with
the investigator and that you follow his/her instructions carefully.
Since alcohol and caffeine affect brain activity, we ask you to stop drinking alcohol
after 6 pm the evening before both visits and to stop drinking/eating caffeinated
goods (coffee, tea, energy drinks, chocolate) 2 hours before the start of each visit.
For this reason, you should also sleep no less than usual the night before each visit,
do not engage in unusual vigorous physical activity the day before and the same day
of each visit, and do not smoke 2 hours before the start of each visit.
In addition, we ask you to respect the items listed below in the procedure (6) and
risks (7) below.
5 Participation and termination:
Participation in this study is voluntary.
You can refuse to participate in the study, and you can withdraw from the study at any
time without giving any reason and without affecting your further relationship and/or
treatment with the investigator or the treating physician.
Your participation in this study will be terminated if the investigator believes this is in
your best interest. You may also be prematurely withdrawn from the study if you do
not properly follow the procedures described in this information letter or if you do not
respect the described items.
When you participate, you will be asked to sign the consent form.

6 Procedures:
6.1
Procedures:
First of all, a screening will take place to check whether you meet the conditions for
participation in the study. This screening consists of online questionnaires of
approximately 30 minutes, covering general as well as personal information about
your health and state of mind.
If you are eligible for the study, you will be asked to come to the MRI unit at the
University Hospital Brussels twice, each visit will take approximately 2 hours. It is
important that there are at least 1week between the visits. You will receive anodal or
sham tDCS per visit. The order of type of tDCS (anodal first and then sham
stimulation, or vice versa) is random and will not be announced until the end of both
visits.
During both studies you will be clearly explained in advance what the experimental
course entails and about the MRI recordings and brain stimulation (briefing). Some
examples are also given until you feel comfortable. A standard questionnaire will be
administered to rule out potential risks from scanning and stimulation.
Then, the researcher will measure your head, to determine where the electrodes of
the tDCS device are placed. Then two electrodes of approximately 2.5 x 2.5cm with
gel are applied to the skull and attached with a rubber band. You will then be placed
in a lying position (supine) in the tube of the scanner. You do not have to undress, but
all metal or magnetic objects (watches, jewelry, bank cards, etc.) must be discarded.
The tube is fairly narrow, but you can see out through a mirror. The device also
makes a lot of noise during the recordings so that you wear protective earplugs. If
you feel unwell, you can let us know by simply pressing a button. The experiment is
then immediately stopped.
In the MRI scanner, you will first be asked to look at a fixation cross for not more than
10 minutes at rest. After that, you will see a video at rest while tDCS is applied for 20
minutes. Then you will see a fixation cross for not more than 10 minutes at rest
again. After this, you will perform a task in which a sequence of cartoons are
presented that together represent a certain action. The cartoons are in the wrong
order and it is up to you to put them in the correct order as soon as possible. This
task takes 15 minutes. Afterwards you will have a second task about emotion
recognition. You will be presented small clips of video depicting an emotion and you
will have to identify which emotion you have seen via a press button. The facial
expressions can be identified as positive, neutral or negative. This task takes 5
minutes. The fixation cross, video and task are all presented on the screen, which
can be seen with the help of a special video glasses mirror. Afterwards you will come
out of the scanner, and we will discuss your impressions of the study together and
give you more information about it (debriefing). You will be asked to complete a
questionnaire after each visit.
The MRI technique does not require injections or medication and is completely
harmless. The examination technique does require that you keep your head perfectly

still for the entire duration of the examination. It will be explained to you which
strategy you should follow in order not to cause unwanted head movement while
swallowing.
6.2
Flowchart:
In summary, the following will happen during the two visits:
At the beginning
▪
Explanation about the MRI recordings
▪
Standard questionnaire administration (excluding risks)
▪
Viewing instructions and examples
Preparation
▪
Remove metal or magnetic objects (watches, jewelry, bank cards
...)
▪
Make head measurements and set up the tDCS device
▪
Place supine in the scanner
▪
Explanation about the emergency button
▪
Explanation of how to avoid head movements
In the scanner
▪
First recording when seeing a fixation cross for a maximum of 10
minutes at rest
▪
Second recording for 20 minute when watching a video at rest
while tDCS is applied
▪
Third recording when seeing a fixation cross for a maximum of 10
minutes at
rest
▪
Fourth recording of 15 minutes when seeing the cartoons
▪
Fifth
recording
of
5
minutes
while
performing
the
emotion
recognition task
▪
Exit the scanner
After scanning
▪
Extra psychological tests (small questionnaire)
▪
At the end of the second visit: we talk about your impressions
and give explanation about the experiment (debriefing).
7 Risks and benefits:
The MRI technique or brain stimulation does not require any injections or medication
and is completely harmless. They are not associated with benefits. No other
technique is able to know so reliable where certain thought processes take place in
the brain. Walking around in the strong magnetic field (3T) of the MRI scanner, some
people experience a feeling of dizziness or see flashes of light. However, with a 3T
device like ours, these complaints are rather exceptional. However, when you

become aware of something, it helps to walk more slowly to make the complaints go
away. Outside the room of the MRI scanner, these complaints should also disappear
by themselves. Due to the rapid switching of magnetic fields and the absorption of RF
radiation (radio waves) during the MRI scan, you may feel slight tingling, small
muscle contractions (chance <20%) or warmth (maximum heating <1 ° C). After the
scan, these complaints should disappear immediately.
The tDCS sessions can in rare cases be accompanied by a few discomforts, the
main ones being mild headache, dizziness and nausea. These complaints are always
responsive to a normal painkiller (eg: paracetamol, aspirin…) and usually disappear
within half an hour. During the start of the tDCS, a mild skin irritation may occur under
the electrodes, but it will disappear fairly quickly. Another point of attention is the
prevention of an epilepsy attack. However, these are very rare when the tDCS
session is performed according to current security guidelines. Also for this reason,
your doctor will ask for a clear history of epilepsy in yourself and in your family. In
very exceptional cases, minor skin burns are found.
Are not allowed to participate (the existence of possible risk factors will be verified
before the study).
●
fMRI scan
If you have one or more of the following contraindications, you may not participate in
this study:
●
Carrier of prostheses and artificial implant
●
Carrier of dental braces or other important dental prostheses
●
If you are claustrophobic,
●
If you are (think you are) pregnant, breast-feeding or cannot guarantee
adequate contraceptive measures for the duration of the study. Are you sure
you are not pregnant? If there is any doubt, it is better not to participate in the
study.
●
Brain stimulation with tDCS
If you have one or more of the following contraindications, you may not participate in
this study:
●
Recent neurosurgical procedures
●
Pacemaker or other electronic implants
●
Inner ear prosthesis
●
Metallic objects or magnetic objects in the brain
●
Heart, respiratory, or neurological problems / conditions
●
Pregnancy
●
Unstable medical condition
●
A current or past psychiatric disorder (for healthy participants)
●
The use of psychotropic drugs (for healthy participants)
●
Skin disorders of the head
●
Skin disorders of the head
●
Because highly changing visual information is displayed, there is a very small
risk of triggering an epileptic seizure during the visual stimulation. This risk is
increased if you or a family member has epilepsy, if you are taking medication
that increases the risk of epilepsy (such as some antidepressants, high doses
of neuroleptics, cocaine and stimulants, if you are sleep deprived in the 24

hours before the test, or during excessively use or withdrawal of alcohol).
Persons belonging to one of these groups are not allowed to participate in this
study.
There is no known permanent risk associated with this study. All tests that are
administered are completely painless and harmless. No injections or oral medications
are given. The only drawback of this research is the additional burden it may cause
you. This is fundamental scientific research and so there is no direct additional
benefit.
fMRI scan:
An anatomical scan of your brain will also be taken as part of this examination. These
scans will be screened by a neuroradiologist. If an unexpected brain disorder
manifests itself on this scan that requires medical attention, the researchers are
obliged to let you know this. If you do not want this, you cannot participate in the
study.
You have the right to ask questions at any time about the possible and/or known
risks, disadvantages of this study. If any information comes to light in the course of
the study that could affect your willingness to continue participating in this study, you
will be notified. Should you experience any disadvantage as a result of your
participation, you will receive appropriate treatment.
This study was approved by an independent Medical Ethics Committee connected to
this hospital and is being conducted in accordance with the guidelines for good
clinical practice (ICH/GCP) and the Declaration of Helsinki issued to protect people
participating in clinical studies. Under no circumstances should you consider the
approval by the Medical Ethics Committee as an encouragement to participate in this
study.
8 Costs:
Your participation in this study does not entail any additional costs for you.
9 Compensation:
For your cooperation, you will receive a compensation of 80 euros for two visits.
10 Confidentiality:
In accordance with the General Data Protection Regulation (or GDPR) (EU)
2016/679 of April 27, 2016, your privacy will be respected, and you will have access
to the collected data.
Any incorrect information can be corrected at your request.
Your consent to participate in the study means that we process your data for the
purpose of the study. The processing of data is legally provided on the basis of article
§ 1, (b), (e) or (f) and article 9, § 2(j) of the General Data Protection Regulation.

All information collected during the study will be pseudonymized (your data can still
be linked back to your personal file). In the case of pseudonymization the key to
those codes will
only be accessible for the examining and treating doctor or the
replacement appointed by him. Only the pseudonymized data will be used for
documentation, reports or publications (in medical journals or conferences) about the
study. Personal information and information concerning your health will be processed
and are kept for at least 20 years. The controller of the data is principal investigator,
Prof. Dr. Chris Baeken. The research team
of the principal investigator will get
access to the personal data. The Data Protection Officer can provide you, if desired,
with more information about the protection of you personal data. Contact details:
privacy@ugent.be.
Representatives of the sponsor, auditors, the Medical Ethics Committee and the
appropriate authorities, all bound by professional secrecy, have direct access to your
medical
records
to
verify
study
procedures
and/or
data,
without
violating
confidentiality. This is only possible within the limits permitted by the relevant laws.
By signing the consent form, after prior explanation, you agree to this access.
You have the right to file a complaint about how your information is used, at the
Belgian supervisory authority responsible for enforcing data protection law:
Data protection law (DPL)
Drukpersstraat 35 – 1000 Brussel
Tel. +32 2 274 48 00
E-mail: contact@apd-gba.be
Website: www.gegevensbeschermingsautoriteit.be
11Injuries as a result of study participation:
The researcher provides compensation and/or medical treatment in case of damage
and/or injury as a result of participation in the study. For this purpose, a no-fault
insurance policy has been taken out in accordance with the law on experiments on
the human person of 7 May 2004. At that time your data may be passed on to the
insurer.
12 Contact persons:
If an injury occurs as a result of the study, or if you would like additional information
about the study or about your rights and obligations, you can contact at any time
during the course of the study:
MSc. B. P. Catoira, Department of Psychiatry, University Hospital Brussels,
Beatriz.Catoira@vub.be
●
Nathalie
Vanderbruggen,
Afdeling
Psychiatrie
UZ
Brussel,
nathalie.vanderbruggen@uzbrussel.be - tel: 02/ 476.35.99
●
Beatriz Catoira, Beatriz.catoira@vub.be tel 0456267472

●
Prof. Dr. C. Baeken, Department of Pyschiatry, University Hospital Brussels, 024766425
●
Prof. Dr. F. Van Overwalle, Psychologist, Free University Brussels, 0499 62 26 49

Informed consent
I,
have
read
the
document
“Information letter and informed consent for participants of experiments” with footnote
“Informed Consent dd. 08-07-09 last adapted dd. 08-02-2022, pages 1 to 8 and
received a copy. I agree with the content of the document and also agree to
participate in the study.
I have received a copy of this signed and dated “Informed consent” form. I received
an explanation about the nature, purpose, duration and foreseeable effects of the
study and about what is expected of me. I was explained about the potential risks
and benefits of the study. I have been given the opportunity and time to ask questions
about the study, and I have received satisfactory answers to all my questions.
I agree to cooperate fully with the supervising investigator. I will notify him/her if I
experience any unexpected or unusual symptoms.
I was informed about the existence of an insurance policy in the event of injury
attributable to the study procedures.
I am aware that this study has been approved by the independent Medical Ethics
Committee connected to the UZ Brussel and that this study will be conducted in
accordance with the guidelines for good clinical practice (ICH/GCP) and the
Declaration of Helsinki, defined to protect people participating in experiments. This
approval was in no way to promote the decision to participate in this study.
I may withdraw from the study at any time without giving any reason for this decision
and without affecting my further relationship with the researcher in any way.
I have been informed that both personal data and data regarding my health will be
processed and stored for at least 20 years. I agree and am aware that I have the right
to access and correct this data. Since these data are processed for medical scientific
purposes, I understand that access to my data can be postponed until after the end
of the research. If I want access to my data, I will contact the supervising researcher
responsible for the processing.
I understand that auditors, representatives of the client, the Medical Ethics
Committee, or appropriate authorities, may wish to inspect my records to verify the
information collected. By signing this document, I consent to this check. In addition, I
am aware that certain data is passed on to the client. I give my consent for this, even
if this means that my data will be transferred to a country outside the European
Union. My privacy will be respected at all times.

I am willing to participate in this study on a voluntary basis.
Name volunteer:
Date:
Signature:
I confirm that I have explained the nature, purpose, and foreseeable effects of the
study to the above volunteer.
The volunteer agreed to participate by placing his/her personally dated signature.
Name of the person that has given preliminary
explanation:
Date:
Signature: