Information

INFORMATION SHEET

Study: Mechanisms underlying spoken language production

Principal Investigator: Dr Jenny Crinion

Contact Details: 0207 679 1129 E-mail: j.crinion@ucl.ac.uk.

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 us if there is anything that is not clear or if you would like more information.

What is the purpose of this study?

The main purpose of this study is to investigate whether two types of treatment (brain stimulation and behavioural therapy) can speed up language recovery from aphasic stroke. We are focusing on word finding problems (anomia), which is the most common problem after aphasic stroke.

Why have I been invited?

Our study investigates speech problems after aphasic stroke. You have been identified as a good candidate for this study as you have reported word finding problems after having a stroke.

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 a consent form. If you decide to take part you are still free to withdraw at any time and without giving a reason. A decision to withdraw at any time, or a decision not to take part, will not affect the standard of care you receive.

What is involved in the study?

There are 2 main parts to this study that will take place on 3 different occasions, 3 weeks apart.  You may want to be involved in only the first part.

What will I have to do if I take part?

In the first part, we will use special brain scans (MRI) to study the effects of speaking in the brain. When you are in the scanner you will answer questions about pictures we will show you on a computer screen. We will measure your brain activity while you are speaking and while you are resting. We will also use special brain stimulation (tDCS- transcranial direct current stimulation) to study the effects of stimulation in the brain and on speech performance. While you are naming pictures you will receive two types of stimulation – real and placebo. You will not know which items you receive the real or placebo stimulation on.

The scans take about an hour. We will also perform some language tests. These tests will take approximately 2 hours. This will mean you coming up to us for a maximum of 3 hours on each occasion allowing lots of time for breaks whenever you need it. We offer some financial compensation for your travel costs - you will be reimbursed at £10/hour up to a maximum of £30. This research project will not interfere with any medical care and treatment you may otherwise be having. We will inform your GP that you are taking part in the study unless you advise us otherwise.

As part of the study we may also require access to read relevant sections of your medical notes. We will ask for your consent before looking at your medical records.

In the second part, once you’ve completed the first part we will enter you into the treatment part of the study. The treatment takes 3 weeks. We want to know if brain stimulation together with a computer form of anomia therapy can improve your speech. For 3 weeks you will have to practice spoken picture naming using a computer programme we will give you for 2 hours a day for 5 days each week at home. We will also give you a home brain stimulation kit to use while you practice on the computer. This will be for 20 mins each day.

Everyone will receive the same computer treatment package. In order to see if brain stimulation interventions are helpful half of the participants will receive real stimulation and the other half placebo stimulation. You will not know which you receive until the end of the study.

On completion of the treatment we will repeat the language measures and brain scans we did in the beginning to look for any change in your speech and brain function. If you complete the whole study, this will take 6 weeks.

Will my taking part in this study be kept confidential?

We will collect basic data from you about your age, sex, and health. Video or audio recordings may also be made at some time points for research and/or teaching purposes, but only with your agreement. These data, along with the test results, will be safely stored on a University computer with all personal identifiers removed so that confidentiality is strictly maintained. All information regarding your participation will be treated as strictly confidential and will only be used for research purposes. Dr Jennifer Crinion will be responsible for security and access to these data. On completion of the study, the results will be published in scientific journals or presented in medical conferences, but identification of the participants will not be possible. We will inform you about these publications and how to access them.

What is the magnetic stimulator that is being used?

The stimulator that we use to activate the brain works by producing an electrical current that activates the part of the brain under the stimulating probe. In this project, this part is the speech production cortex. The procedure is painless and has been used in this university and other centres throughout the world for 20 years. For the past 5 years, it has been used in patients at different time intervals after their stroke, to test whether it can improve some of their aphasic symptoms.

Are there any risks or side-effects involved?

Because the brain scanner works by using magnetic fields, it cannot be performed on people who have implants such as cardiac pacemakers, aneurysm clips in their brain, ear implants, permanent eye lining, or have been exposed to metallic flakes or splinters travelling at high speed. The MRI scanner may also not be suitable for people with claustrophobia. Please inform the investigators if you might fall into any of these categories. tDCS can theoretically cause seizures. Please note that since the introduction of agreed safety guidelines (which we will implement), there have been no reports of seizures. If you ever had any kind of seizures (fits) or you were on anticonvulsant medication at any time, please inform the investigators. In the unlikely event of a seizure, we will have to end your participation in the study. The driving license authority (DVLA) has told us that they would not disqualify you from driving. Besides seizures, the only known risk of the brain stimulator being used is mild headache, which has always gone away promptly with non-prescription medication, and muscle tension.

What are the possible benefits of taking part?

This study may or may not help you directly. The information we get from you taking part in this study will help improve the treatment of people with anomia after stroke in the future.

What if there is a problem?

If you have a concern about any aspect of this study you should speak to the researchers who will do their best to answer your questions. In the event that something does go wrong and you are harmed during the research and this is due to someone’s negligence then you may have grounds for a legal action for compensation against UCL, but you may have to pay your legal costs. The normal National Health Service complaints mechanisms will be available to you.

What will happen if I don’t want to carry on with the study?

Your participation in the study is entirely voluntary. You are free to decline to enter or to withdraw from the study any time without having to give a reason. If you choose not to enter the study or to withdraw once entered, this will in no way affect your future medical care. Participation in this study will in no way affect your legal rights.

Organization and funding

This study is organised by the Institute of Cognitive Neuroscience and funded by the Wellcome Trust. Dr Jennifer Crinion is the principal investigator. The study has been reviewed by a NHS national research ethics committee: London – Queen Square, ref: 16/LO/0901.

Below is the list of all researchers involved in this study. Dr Jennifer Crinion is the study-coordinator to be contacted in case of queries. Her contact details are at the front of this information sheet.

Research Team: Dr Jennifer Crinion, Dr Davide Nardo, Prof Alexander Leff, Prof John Duncan.