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Information for Participants
You are invited to take part in a research study. Before you decide whether or not to take part, it is important that you read the following information carefully. Ask us if there is anything that is not clear or you would like to know.
What is the purpose of the study?
The study will use magnetic resonance imaging (MRI) to take images of your brain and electroencephalography (EEG) to record the electrical activity of your brain. The main purpose of this study is to understand how brain regions are linked to each other and how information from one region is transmitted to another. We aim to build a network of connections that are present in the ‘average’ healthy brain. Subsequently, we will develop methods that identify differences between healthy brain networks and diseased brain networks. We hope that this will help in creating more accurate tools to detect brain disorders.
What are the selection criteria?
We would like to hear from people who:
are between the ages of 18 and 60 and
do not suffer from any brain disease or neurological deficits
do not receive any medication
Who should not take part?
People who fall under the following categories should NOT take part in the study:
People with metallic implants in their body
People who receive medication.
People with cognitive impairments or neurological deficits/disorders.
Do I have to take part?
No. It is up to you to decide whether or not to participate in the study. If you decide to take part you will be given this information sheet to keep and asked to sign a consent form. If you decide to take part, you are free to withdraw at any time during the study and without giving a reason.
What will happen if I take part?
If you agree to take part in the study, you will be invited to come to Great Ormond Street Hospital twice.
The MRI scanner we use is similar to the one pictured here. The small picture at the corner shows how the EEG cap looks once it is fitted. The scanner operator will ask you to lie down on the bed and will use cushions to make you comfortable. You will be given an emergency button you can press at any time if you feel uncomfortable and want to stop the scan. Note that the operator will be in constant communication with you. The scan environment can be noisy and we will provide you with headphones to reduce the noise and allow you to hear the operator.
Each scanning session will last around 45-60 minutes. In the first session, we would only acquire structural data and it would no need to wear the EEG cap. During scanning it is important you do not move to allow us to acquire high quality data. We can provide you with a variety of movies to watch. You are also welcome to bring your favorite DVD to watch or listen during the scan.
In the second session, we would need to fit the EEG cap to your head to acquire simultaneous resting-state EEG/fMRI sequences of data. ‘resting-state’ implies that you will not performing any task. The EEG cap has sensors that allow the brain electrical activity to travel from your head to the machine. To acquire high quality data the sensors must be well adjusted and in contact of the skin of your scalp. Fitting the EEG cap would require additional preparation of up to 40 minutes and the application of conductive gel. Gels are absolutely safe but you should wash them away after the scanning session. We provide clean towels, shampoo and a hair drier.
After the second scan we will give you a CD with all the data and images of your brain. Reasonable traveling expenses may be refunded upon request.
Are there any side effects or risks involved in MRI scanning?
There are no known side effects of being scanned using MRI and or EEG. MRI does not involve any radiation, but uses magnetic fields and radio waves to create the images. These are considered very safe and are used every day in hospitals all over the world.
MRI scans take place in a strong magnetic field, therefore participants with metal implants or medical devices cannot take part. Before the MRI scan takes place, we will help you complete a MRI Safety Checklist, which helps us assess if it is safe to scan you.
Very occasionally, there will be unexpected findings in the brain images. In this case the images will be reviewed by an experienced neuro-radiologist. If there are any unexpected findings that warrant further tests, he or she will provide you with a short report and would ask you to contact your GP. We should stress however that the scans being performed are for research purposes and not optimised to detecting clinical abnormalities. The images will not be automatically reviewed by a neuro-radiologist unless abnormalities are found during the normal course of research. Therefore, these brain scans should not be considered a clinical examination.
How do I prepare for the MRI scan?
Please wear loose, comfortable clothing with minimal metal fastenings. You will be asked to leave any metallic objects you are carrying (for example, coins, keys, jewellery and mobile phones) in the lockers provided. In order to have an MRI scan you will need to complete an MRI Safety Checklist and sign a Consent Form.
What are the possible disadvantages of taking part?
The study will take up a bit of your time and we would like to visit Great Ormond Street Hospital twice.
The scanner environment could make you feel uncomfortable if you experience claustrophobic symptoms. If you feel uncomfortable, you could stop the experiment any time.
What are the benefits of taking part in the study?
There are no direct benefits to you for taking part in the study. However, our findings will help researchers understand the normal pattern of brain connectivity in the human brain. Our work aims to build a detailed statistical model of population variability that would allow the development of robust biomarkers in clinical practice.
Will my results be kept confidential?
Yes. All data will be collected and stored in accordance with the Data Protection Act 1998. The information we collect will be made anonymous and kept strictly confidential. We will not give your scans or personal details to anyone else without your written consent.
What happens to the results of the research study?
These results may be presented at scientific conferences and presentations, where all the images and results will be anonymous. We plan to publish the results in scientific journals, but this can take up to three years from the end of the study. We will publish our results to this webpage to keep you updated.
Who is organising and funding the study?
This study is organised by UCL and sponsored by EPSRC.
Who has approved the study?
This study has received ethical approval from the UCL Research Ethics Committee (Project ID: 4290/001)
How to contact us
If you have any questions, please ask. You can call or email me on the details below:
Dr. Fani Deligianni
Phone: 44 (0) 20 7905 2202
Fax: 44 (0)20 7905 2358
Email: f.deligianni@ucl.ac.uk
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