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Systematic Eye movement training for people with Hemianopia
You are being invited to take part in a research study.
Before you decide whether to take part, 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 feel free to ask us if you would like more information or if there is anything that you do not understand.
Part 1 tells you the purpose of this study and what will happen to you if you take part.
Part 2 gives you more detailed information about the conduct of the study.
Ask us 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 a part.
Thank you for reading this.
What is the purpose of the experiment?
Loss of vision in parts of the outer (peripheral) visual field occurs commonly in survivors of strokes that affect the visual system. One rehabilitation technique is ‘visual search training’. This aims to help participants by teaching them to systematically look around (scan) the environment to compensate for their visual field loss. While there is good evidence that the treatment technique works, the exact mechanisms are not well understood.
We would like to scan the brains of volunteers that undergo visual search training at three stages of the training to document any changes in the brain. This knowledge could be used to match treatment methods better to individual needs.
• In this study we will provide 6 weeks of eye movement training and measure how well people respond to this treatment.
• We expect to see an improvement in the time it takes participants to find targets in the surrounding space
• We will look at how the learning is linked to changes in the brain.
Do I have to take part?
Your participation in this study is completely voluntary, and you are free to withdraw from taking part at any time.
Potential benefits of taking part in this study
Participants may feel some eye movement improvements which could reflect positively on their daily life activities, such as reading or driving.
What will happen if I take part?
Before we start:Before taking part in this study the researcher will visit you, either at your home or at another convenient place, to show you what the training involves and answer any questions you may have.
During the study we will take detailed images of your brain structure and measure which areas are active during visual tasks.
Before we scan any participant, we have to make sure that this is risk free.
We will therefore informally discuss the requirements for scanning at this visit.
Taking part in the study:
You will be asked to take part in ‘eye movement training’ at home for six weeks. The training will take around 30 minutes every day for five days per week. The training will be done on a computer that we will supply and the researchers will support you to do the task easily at home. The computer you will use for the training will collect your results and we will ask you to write a diary recording what training you did over this period. Our main aim is to record changes to your brain while you perform the eye movement training. We will therefore scan your brain before the training starts, then 2 weeks after the start date and lastly at the end of training period. This means that you will have to visit the Imaging Centre at The University of Liverpool three times. Each visits takes around 1 hour. We will arrange travel for you and pay for this.
What happens during the assessment?
• At each visit in the imaging centre the researcher will ask you to perform an eye movement experiment using a computer. The task will take around five minutes to complete and is very similar to the training task you perform at home. The researcher will explain exactly what you need to do at the time of the test.
• We will also scan your brain to measure a number of different things: Some scans will measure your brain structure, and you will be required to simply lie as still as you can in the scanner; this scan will take 20 minutes.
• Other scans will measure brain performance while you do a visual task. There are two visual tasks in the scanner and each one will take 8 minutes. You will be asked to look for a visual target and press a left button for Triangle shape and a right button for Circle shape as soon as you see the target. Total scan time will be 40 minutes.
• Before the scan you will be asked to fill in a short safety screening form to make sure there are no reasons why you would not be suitable for magnetic resonance scanning. Also, you will be asked to sign a consent form before starting the scanning. If you have difficulty writing, someone independent can witness your agreement to take part and sign the form instead.
• When we scan your brain, you will be asked to wear a hospital gown (changing rooms are provided) and remove items which are affected by the magnetic field (e.g. hearing aids, mobile phones, keys, coins, pens, credit cards - secure lockers are provided).
• Magnetic resonance scanning is noisy (so you will need to wear disposable earplugs that will be provided by the researcher) but cause no pain, harm or long-term effects.
• Some people may experience slight feelings of claustrophobia in the scanner. If you do feel uncomfortable, you will be able to notify us we will remove you from the scanner without delay.
• We will ask you not to speak during or between experiments, although we can hear you if necessary.Expenses and / or payments
The study will cover the transportation costs for all visits. The transportation costs will be only for participants, not for carers. You will be provided with the train tickets in advance for all visits (all visits will be scheduled) or you will receive transportation costs as an online bank transformation for each visit. We expect no more than £ 100 for all three visits if you live in the local area and no more £ 300 for all three visit if you may come from far distance. All transportation costs will be discuss with you at the first meeting before making a decision to take part in this study.
What are the possible disadvantages and risks of taking part?
The eye movement training could be quiet inconvenient for some people. The magnetic resonance scanning is noisy, but otherwise there are no reported long-term effects. High quality disposable earplugs will be provided to protect against the possibility of hearing loss. Some people may experience slight feelings of abnormal dread in closed or narrow spaces of the scanner. If you do feel uncomfortable you will be able to notify us immediately and we will remove you from the scanner without delay.There are no known risks in properly conducted magnetic resonance scanning. As it involves a strong magnetic field, certain standard precautions will be observed. Most importantly, we will NOT study you if you are fitted with a heart pacemaker, mini-defibrillator or a device that provides electrical stimulation to nerves (as to relieve intractable pain or suppress tremors); if you have surgical clips in your head; if you have suffered injuries that may have left metal particles in your eye or head, or elsewhere in your body; or if you have an artificial heart valve. We will also ask about other kinds of surgery and metal implants that might affect your suitability.
Occasionally research studies using magnetic resonance imaging reveal significant unexpected abnormalities that require medical follow-up, either for further investigation or (more rarely) treatment. The scans we do are for research purposes, but we review them carefully to avoid missing such an abnormality. We will spend a few extra minutes taking high-quality images that will be reviewed by a consultant physician. If any significant abnormality is found, we will send the report to your GP, who will be able to discuss it further with you. Please note that this is not a substitute for a ‘medical’ magnetic resonance scan that a doctor might order to make a diagnosis. It should therefore not be considered a ‘health check’. There are no known risks related to the eye movement training that you will be asked to do during the first part of the study.
Will my taking part be covered by an insurance scheme?
Participants taking part in a University of Liverpool ethically approved study will have insurance cover.
What will happen to the results of the study?
The results of the research study will be presented at research meetings and published in scientific literature, so that other researchers can also benefit from the sharing of information. The study will take at least three months to conduct and longer to analyse fully, but we would be happy to supply you with our results after this time.
What will happen if I want to stop taking part?
During the study, you are able to withdraw at any time without explanation. Your results up to the period of withdrawal may be used, if you are happy for this to be done. Otherwise you may request that they are destroyed and that no further use is made of them.
What if I am unhappy or if there is a problem?
Will my participation be kept confidential?All information will be kept private, confidential and secure. Only people involved in this study or in making sure it is run correctly will be able to look at your records.
Who can I contact if I have further questions?