Dr. Beth Jefferies
Department of Psychology
University of York
York, YO105DD
01904 324368
Email:
Participant Information Sheet
A STUDY OF MEMORY AND LANGUAGE AFTER ELECTRICAL STIMULATION
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. Talk to others about the study if you wish.
This sheet tells you the purpose of this study and what will happen to you if you take part. Please 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.
What is the purpose of the study?
This study explores the brain basis of semantic memory. Semantic memory refers to the meanings of words, pictures, objects and faces - our general factual knowledge about the world. Unfortunately, many people have difficulty accessing their store of semantic information following a stroke or brain injury.
We are interested in using a method called direct current (DC) stimulation to enhance semantic processing. We want to establish if this method could be used to assist recovery of semantic processing after stroke or brain injury.
Why have I been chosen?
We are looking to recruit participants with brain injury for this research. You will be able to take part if:
· You have had a stroke/brain injury at least 6 months ago
· You have language and/or memory problems resulting from the brain injury
· You are aged between 18 and 80 years
· You are otherwise in good health
You will not be able to receive stimulation if you have:
· Had a seizure within the last 12 months
· Damaged or diseased skin on your face and scalp, or a sensitive scalp
· A history of alcohol or drug addiction, or severe psychiatric illness
· A metal implant (except in the mouth), cardiac pacemaker, implanted medication pumps or neural stimulators, cochlear (ear) implant
· Drug treatment which may lower seizure threshold
· Pregnancy
· Sleep deprivation (less than 6 hours a day)
· A history of migraine or headaches
· Claustrophobia (which may make the brain scan uncomfortable)
Do I have to take part?
No. It is up to you to decide whether or not to take part. If you do, you will be given this information sheet to keep and will be asked to sign a consent form. You are still free to withdraw at any time and without giving a reason. This will not affect the care you receive.
What will happen to me if I take part?
The study will be over several sessions.
There will be some language and memory tests, similar to activities you may have done with a speech therapist or psychologist. You can arrange to meet with the researcher when is convenient for you, at your home or the university. Each session lasts no longer than two hours, and you can take a break if you’re tired.
We may ask you to have an MRI brain scan at the university. This involves lying in a scanner, with your head in a hole, whilst a magnet forms an image of your brain. This lasts around 20 minutes. You will need to keep very still in a confined space and the scanner is very noisy. Additionally, we may ask you to do some tasks involving words and pictures whilst in the scanner. This lasts around half an hour.
DC stimulation testing will be done at the University of York. There may be several stimulation sessions, never occurring on the same day. The researcher will provide more information referring specifically to your study.
Before taking part, you will be asked to fill out some questionnaires. These will ask you about your medical history, about drugs you might be taking and whether you might be pregnant. This information is important to ensure your safety so it is important to answer accurately and to tell the researcher if you are unsure about anything. Your answers will be kept strictly confidential.
The brain stimulation method will involve placing rubber electrodes soaked in saline solution on your head. When the stimulation starts, you may feel a tingling or a mild burning sensation but this should quickly pass and it should not be painful. Please tell the researcher if you feel uncomfortable at any point. You may have a taster session in advance if you would like to know how it feels.
Some participants in this study will receive real stimulation, and some will receive “sham” stimulation, which only lasts for a few seconds. The sham stimulation is not expected to alter language or memory performance. We will not be able to tell you beforehand which type of stimulation you will receive, but we will tell you afterwards.
The researcher will ask you to perform some tasks before, during and after the stimulation. These involve paper and pencil tests and pressing buttons in response to things displayed on a computer screen. The researcher will be able to give you more detailed information about these tasks.
We may ask you to participate in follow up sessions to see your improvement over a period of months.
Payments to participants
We will reimburse you for travel costs by car or train.
Are there any risks of taking part?
DC stimulation and the brain scanning method (MRI) are both well-established techniques used in many laboratories and hospitals around the world. The stimulation protocol we are using is a standard one that has been tested for safety by several research groups. It is not thought to carry a high-risk of side effects. However, if you do experience any negative effects during or after each session, please discuss these with the researcher.
For your own safety, during both DC stimulation and MRI, it is very important to answer the questions on the safety screening questionnaire accurately. As noted above, certain individuals with neurological or psychiatric conditions, who are taking certain medications, who have had major surgery on the head or neck, who have metal in their head or body, or who are pregnant cannot take part. If you are unsure whether you are suitable for the study, please talk to the researcher. Any information you provide will be kept completely confidential.
DC stimulation can be uncomfortable when it starts. You may feel a tingling or a mild burning sensation but this should quickly pass and it should not be painful. You can tell the researcher if you want the stimulation to be stopped at any time.
The brain scan using MRI involves strong magnetic fields. For this reason, you must not take any metal objects into the scanner room. The scanner is also very noisy. We will ask you to wear eye plugs to protect your hearing.
There is a small chance that MRI will detect something wrong with your brain that you didn’t know about. If this happened, it might allow action to be taken quickly that would benefit your health, but it might also cause you to worry, and could affect your health insurance. We are not qualified to interpret brain images clinically. If we suspect that an image of your brain reveals a possible problem, we will inform your GP (family doctor) who may then contact you and advise you.
What are the potential benefits to taking part?
This study is exploratory, so we hope to find out about the possible benefits of DC stimulation. From results of previous studies, we hope that semantic and language processing will be improved. This may help treatment of brain injured patients in the future. However, we cannot guarantee that any individual will personally benefit from the stimulation.
What will happen if I don’t want to carry on with the study?
If you feel uncomfortable about any aspect of the study, please let us know straight away. We will discuss your concerns with you and may be able to help. You are free to withdraw from the study at any time. If you decide to withdraw, please tell the researcher. Data that has been collected can be deleted at the your request, and personal information from participants who withdraw will be destroyed. It is not normally possible to use data from participants who withdraw from the research.
What if there is a problem?
If you have a concern about any aspect of this study, please speak to the researchers who will do their best to answer your questions. You can contact Dr. Beth Jefferies, who is leading this study (01904 324368; ). If you remain unhappy and wish to complain formally, you can do this through the complaints procedure of the University of York.
The York Neuroimaging Centre takes pride and care in ensuring that no harm, or risk of harm, occurs to participants in research. In the event that something does go wrong and you are harmed during the research study and this is due to someone’s negligence, then you may have grounds for a legal action for compensation against The University of York.
Will my part in the study be kept confidential?
Any information that you give us and all of the measurements that we collect will be confidential. No names will be used when the research is written up. The information will be held securely in anonymised computer files and in locked offices. Names and addresses will be stored separately from other data.
We will use your data in this study and may combine it with data that we gather in future studies. We will keep the data until it is no longer useful for the research and will then destroy it securely. We will comply with the terms of the Data Protection Act 1988.
The contact details of participants will be accessible to Dr. Beth Jefferies and her research team but will not be passed to anyone else. In addition, staff of the York Neuroimaging Centre have privileged access to the computer systems and can link the names of participants with their data. Those people are under a professional obligation not to abuse this privilege. With the approval of the Research Ethics Committee of the York Neuroimaging Centre, other researchers may be allowed access to the data for use in research and teaching but in anonymous form only.
What will happen to the results of the study?
The results will be written up in scientific journals and talked about at conferences. It will not normally be possible to give feedback about performance to individual participants because the data are taken away and analysed at a later date. However, we will be happy to provide a summary of the results when they become available.
Who is organising the research?
This study is being led by Dr. Beth Jefferies who is a Reader in the Department of Psychology, University of York. The study also involves Hannah Thompson, a researcher at the University of York.
Who is funding the study?
The study is being funded by the Stroke Association.
Who has reviewed the study?
The study was given a favourable ethical review by the NRES Yorkshire and Humber Research Ethics Committee. It was also peer-reviewed as part of our application for funding from the Stroke Association.
Contact details of the researchers
For further information, please contact Dr. Beth Jefferies, Department of Psychology, University of York; ; Phone: 01904 324368
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Information sheet date of issue: 24/8/2012
Version number: 2
REC reference: 12/YH/0323