Appendix 1 – MEG Volunteer Information Sheet

MEG Volunteer Information Sheets

Study title

MEG correlates of episodic memory processes using confidence judgements.

Introduction

You are being invited to take part in a research study. Before you decide it is important for you to understand why the research is being done and what it will involve. Please take time to read the following information carefully and discuss it with others if you wish. Ask if there is anything that is not clear or if you would like more information. Take time to decide whether or not you wish to take part.

Thank you for reading this.

What is the purpose of the study?

We are a group of scientists studying the processes involved in retrieving information from memory. One method which can help us to understand these processes is MEG (MagnetoEncephaloGraphy). Using this method we can measure activity from various parts of your brain while you complete some simple memory tasks. MEG is informative because it can tell us which areas of the brain are active while completing these tasks and importantly when this activation occurs with millisecond precision. This information can then be used to inform theories of memory retrieval.

Why have I been chosen?

As a volunteer you responded to our request for healthy adult subjects to participate in the study.

Do I have to take part?

It is up to you to decide whether or not to take part. If you do decide to take part you will be given this information sheet to keep and be asked to sign the attached consent form. If you decide to take part you are still free to withdraw at any time and without giving a reason.

How many scanning sessions are involved?

You will be asked to visit CUBRIC once for an experiment which will take a maximum of 2.5 hours of your time in total. During this session the following will happen:

1. After reading the information sheet and filling out the consent form you will do a practice study phase so that you are familiar with the instructions and then the actual study phase. Although you will be in the scanner for this part we will not be recording brain activity.

2. You will then come out of the scanner and be set up for the MEG recording.3. You will then complete a practice test phase before completing the actual test phase. Brain activity will be

recorded in the test phase and this will take around one hour. There will be breaks in the test phase.4. Debrief and payment.

What do I have to do before the scanning sessions?

There are no restrictions on lifestyle or diet before taking part in this study. As the scan can be quite long, you may wish to use the toilet before the scan.

What are the possible benefits of taking part?

This study involves the recording of typical brain function. Since we are only studying healthy volunteers, there is no intended clinical benefit to you from taking part this study. The scans are not intended to provide a medical diagnosis or a clean ‘bill of health’ – and the person conducting your scans will not be able to comment on the results of your scans.

What happens if you find something unusual on the scan?

The researchers involved do not have expertise in MEG diagnosis, as they are psychologists or allied scientists and are not doctors. You should not regard these research scans as a medical screening procedure. Occasionally when we image healthy participants, the researchers may be concerned that a potential abnormality may exist on the scan. In this case, we will ask a neurological consultant, such as a neuroradiologist, with MEG expertise to examine the scans, and if appropriate a report can be forwarded to your GP. However, in most cases a neurological consultant will not look at the images.

It is important that you realise that these scans will not provide any information that may help in the diagnosis of any medical condition. If you do have any health concerns, you should contact a qualified medical practitioner in the normal way.

Are the procedure and results confidential?

All information which is collected about you during the course of this research will be kept strictly confidential. We may share the data we collect with researchers at other institutions, but any information which leaves the CUBRIC centre will have your name and address removed so you cannot be recognised from it. Any information about your identity obtained from this research will be kept private. In any sort of report we might publish we will not include information that will make it possible for other people to know your name or identify you in any way. You will be simply referred to by your gender, age and possibly some characteristic such as left or right handedness.

What will happen to the results of the research study?

Where appropriate, the results of this study will be presented at medical and scientific conferences and published in journals. You will not be identified in any report or publication. The results of this study will also help us to design future research projects, and possibly lead to new methods of diagnosis for neurological conditions.

Who is organising and funding the research?

This research has been funded by the Biotechnology and Biological Sciences Research Council (BBSRC).

Who has reviewed the study?

This study has been reviewed and approved by the Cardiff University School of Psychology Ethics Committee.

Contact for Further Information

Experimenter: Principal Investigator:Dr Lisa Evans Prof Ed WildingSchool of Psychology School of PsychologyEvansLH@cardiff.ac.uk WildingE@cardiff.ac.ukTel: 02920 870080 Tel: 02920 875453

The following pages describe the MEG scanning procedure in more detail. Please read them carefully.

The MEG Recording SessionWhat is MEG?

MEG is an acronym for Magneto-Encephalo-Graphy and is a non-invasive technique that measures the magnetic fields generated by neuronal activity of the brain.

Because magnetic fields pass through the skull and scalp as if they were transparent, they can be measured outside of the head using the MEG scanner. The magnetic field is extremely small but can be detected by sophisticated sensors that are based on superconductivity.

The magnetic fields from the brain are so small that electrical noise from the building and distant moving objects, such as cars on nearby roads, can “swamp” the signals we are trying to record. For that reason the MEG scanner is housed in a specially shielded room and we will need to shut the door to this room before the recording starts.

MEG produces an “activity map” or “functional image” of your brain. Importantly, an MEG scanner can accurately track the timing of activity as it moves around your brain. There are no side effects and it doesn’t hurt – in fact you will not even be in contact with the scanner. Importantly, MEG does not produce radiation of any sort – it is simply a passive recording device.

Please note that the MEG studies we perform are not diagnostic procedures and cannot be regarded as any kind of health check. The researchers who scan you will not be medical doctors and will not be looking for any kind of clinical abnormality in the data.

If you do have any health concerns, you should contact a qualified medical practitioner in the normal way.

An example of a volunteer being scanned using MEG while viewing a visual stimulus

MEG is shedding light on some of the fundamental workings of the human brain. Studies that involve healthy volunteers form the basis of this and are a vital part of our research program. Through such work, we are learning about typical brain function in areas such as language, vision, movement, memory, thought and emotion.

Who cannot have an MEG scan?

Anyone who has a cardiac pacemaker, metallic implants in the upper half of their body or a history of metal entering the eye will not be suitable for an MEG study. This is because the metal will cause interference to the MEG signal that is recorded.

As these experiments examine brain activity associated with memory for verbal stimuli in healthy young adults, you will also need to be a native English speaker, aged 18-35. You will be unable to take part if you are taking any medication for epilepsy/depression/anxiety, or if you have been officially diagnosed as being dyslexic.

What will I have to do during the MEG scanning session?

This MEG experiment will examine your memory. Words will be presented in the study phase and you will be asked to complete a size or animacy judgement. You will then be given a memory test and have to decide if a

word is new or has previously been presented, and if so which task you encountered it in. Detailed instructions will be given to you before you start the memory experiment.

While you are completing the test phase of the memory task MEG will be recorded. Please try to keep your head as still as possible. This is easiest if you relax. All that we need you to do is to keep still and perform the task to the best of your ability. During the tasks the Researcher, who will also ensure your comfort, will constantly monitor you.

The scan itself:

1. Before entering the MEG shielded room, you will be asked to remove any metal objects from your person including keys, coins, jewelry and watches. You will also need to remove credit cards and travel-cards, belts and under-wired bras. It might be best for you to bring a change of clothes – sweatshirt and jogging pants are ideal. We have our own private changing room for volunteers. Your valuables will then be locked away for security reasons. If you are wearing make-up you may be asked to remove this as well.

2. The Researcher will check again that it is suitable for you to have a MEG scan by going through a screening questionnaire. The scan format will then be explained to you.

3. You will be taken into the MEG room and asked to sit down on a special chair, which moves up towards the MEG scanner. Three special devices, called head localiser coils, will then be placed around your head/face. This allows us to see exactly where your head is in relation to the scanner whilst your brain activity is recorded. You will then be moved up towards the scanner so that the top of your head is inside the helmet. Several checks associated with the specific study will then be carried out.

4. For the experiment itself, you will view a computer screen on which different words will be shown to you. Nothing distressing in nature will appear on the computer screen, although you can stop the scan at any time.

5. The Researcher will be able to talk to you via an intercom in between the runs of the experiment. You will be given an alarm bulb so that you can call us during the scan, if something is wrong or you want to come out. A camera will also observe you to make sure you are okay – this camera is an infra-red one and hence works in the dark.

6. During the experimental scans, you will need to carry out the tasks previously explained to you. These may last between ½ to 1 hour, depending on the specific experiment.

7. All we ask, is that you carry out the tasks as explained, keep your head very still at all times, stay awake and most importantly, try to relax!

8. After your scan you will leave the MEG room, and you will sit in a chair while a pen is traced around your head. This is so that an accurate computer model of the shape of your head can be produced.

Some further advice:

If you suffer from any neurological conditions, such as epilepsy or routinely suffer from migraines please let us know before you come for your scan – you will not be scanned if you have these conditions.

Wear soft, loose but warm clothing which preferably has no metal fixings. The scanning room is slightly cool (for computer comfort).

What are the side effects of taking part?

This research involves minimal risk. The MEG scanner is completely passive i.e. it records magnetic fields generated by your brain. There are no side effects associated with MEG scanning and there are no after-effects from the scan.

However, concentrating on a computer screen for so long, and keeping still in the same position, can be a little disorienting and so it is probably wise to wait for a few minutes after the scan before driving.

During the study and test phases you will be asked to blink only at certain points in the testing sequence. This will be approximately every four seconds. Some people may find this difficult, but we just ask that you do this to the best of your ability.

What are the possible disadvantages and risks of taking part?

Some people find being inside the MEG shielded room a little claustrophobic. If you find the experience unpleasant for any reason, just let us know straightaway and we will stop the scan and take you out of the scanner.

Because the shielded room is an enclosed space, and the MEG system is filled with helium, we monitor the amount of oxygen in the room. If the oxygen alarm sounds, the researchers will simply open the door and remove you from the scanner. If this happens, do not panic or rush to leave the chair – please remain seated. There is plenty of time to safely remove you from the room.