CONFIDENTIAL
National Hospital for Neurology & Neurosurgery
London
WC1N 3BG
Telephone: 020 7837 3611
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.
Your stroke has resulted in damage to part of the brain needed to make movements of the arm. Over the first few weeks and months these movements often become easier but many patients complain of mild to extreme fatigue that interferes with performing movements and activities of daily life. Fatigue occurs even without any previous exertion. The reason behind development of fatigue is not clear but previous research suggests that it could be due to changes within the areas of brain that control movement. In this study, we use brain stimulation, questionnaires and brain scans to gain information about the area in the brain that contribute to development of fatigue following a stroke. There may be no direct benefit to you from these assessments but we hope that the information obtained will allow us to better understand this process and that this may then guide the future development of treatments to enhance recovery.
We are approaching you because you have had a stroke. We aim to study 142 patients who have suffered from stroke. If you decide to take part you will be given this information sheet to keep and be asked to sign a consent form, which you will also be given to keep. Your participation in this trial is entirely voluntary. Even 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.
If you decide to take part, the experiment takes place over three separate days. On day one, we will carry out some simple physical tests – holding objects, lifting the arm etc, in order to measure how
The University College London Hospitals
University College London Hospitals is an NHS Trust incorporating The Eastman Dental Hospital, The Hospital for
Tropical Diseases, The Middlesex Hospital, The National Hospital for Neurology & Neurosurgery, The United Elizabeth
Garrett Anderson Hospital and Hospital for Women, Soho, University College Hospital and The Heart Hospital.
Information sheet – Neurophysiology of Fatigue After Stroke (NeuroFAST) Version 2, 15/10/2012

well recovered you are. You will also be asked to answer two questionnaires to assess your level of fatigue and check if you may have symptoms of depression. The first questionnaire has 19 questions about your fatigue levels and the second questionnaire has 14 questions about how anxious you may feel. In takes around 10 to 15 minutes to answer the questionnaires and some information required is of sensitive nature. This will be followed by use of brain stimulation technique called Transcranial
Magnetic Stimulation to assess changes in your brain after the stroke. This technique is explained in detail below. On the second day these tests will be repeated after exercising the arm affected by your stroke.
Some individuals will be invited to come for a third day, when they will be asked to perform few simple tasks with their hands while they are in an MRI scanner.
The different techniques that will be used over the 3 days are explained below.
(i)
We are using TMS to measure the effects of stroke on the connections between your brain and finger muscles. The
TMS experiment will take 1.5 hours. During this time there will be frequent breaks when you can rest. The first 30 minutes will be spent setting up the equipment and making sure that you are comfortable with the stimulation. In order to measure the effects of stimulation we will attach small electrodes to the skin of your fingers with sticky tape. This is completely painless. By stimulating the region of the brain that controls your fingers while you perform a task, we will be able to determine how ‘fatigued’ that region of your brain is. As shown in the picture a magnetic coil will be in contact with your scalp while the stimulation is delivered. The sensation on your head will feel like a tap on your head while the stimulus is being delivered. During this procedure you will be seated in a chair with your arm in front of you on a table performing a simple task such as squeezing a ball or pushing against a bar or simply resting with yours arms comfortably resting on a pillow. Stimuli will be delivered once every 10 seconds and the procedure can be stopped at any time you wish.
(ii)
Magnetic Resonance Imaging (MRI) scans will be taken of your brain so that we can look at both the structure and function of your brain. Before entering the scanner you will be asked to remove any
Information sheet – Neurophysiology of Fatigue After Stroke (NeuroFAST) Version 2, 15/10/2012

metal objects from your person including keys, coins, jewellery and watches. You will also need to remove credit cards and travel-cards, belts and under-wired bras. Your valuables will then be locked away for safe keeping. If you are wearing make-up you may be asked to remove this as well. Either before or immediately after scanning a doctor will carry out some simple physical tests – holding objects, lifting the arm etc. This allows us to measure the extent of your recovery.
During the scanning session you will lie on a couch inside the scanner, with your head in a specially designed headrest, which is cushioned for comfort. Inside the scanner there are speakers, an intercom so that you can speak to us and a screen on which instructions will be shown. The scanner makes a loud clicking noise so we will give you earplugs to wear. The scan can be stopped at any time. The scanner is identical to one which you may already have had done to make the diagnosis of stroke. We will explain the details of what to do during the scan and give plenty of time for practice beforehand.
The following types of scan will be performed. a) Functional MRI
Functional MRI is scans allow us to look at which parts of your brain are being used at rest and during movements of the hand. You will be asked (i) to rest with your eyes closed for and then (ii) to move your hand or finger in response to a simple instruction shown on the screen that you can see. This part of the experiment will take about 10 minutes. b) Structural MRI
Structural MRI scans allows us to look at the structure of your brain in detail. This scan lasts about 10 minutes. During this time you can relax and even close your eyes as long as you keep your head still.
The structural MRI allows us to look at where the stroke has affected you.
The detailed structural image of your brain is acquired to allow us to study your stroke in detail for research purposes only and is not optimised to detect all abnormalities. However, in the unlikely event of unexpected abnormalities on your scan, a medically qualified member of our research team will discuss this with you. As we do not carry out scans for clinical purposes, it will be necessary to inform your GP so that appropriate action can be taken.
Both TMS and MRI uses magnetic fields. Therefore, they can be harmful to people who have a pacemaker, an implanted medication pump, a metal plate in the skull or metal objects inside the eye or skull (for example after brain surgery or an accident). Please inform the investigators if you think this might apply to you.
MRI is a painless and safe technique, which can obtain detailed pictures of the brain. As the name implies it uses magnetic fields to generate the pictures and unlike X-ray techniques there is no ionising radiation used. As long as people with any magnetic metal implants are excluded (see above),
There are no known risks.
Information sheet – Neurophysiology of Fatigue After Stroke (NeuroFAST) Version 2, 15/10/2012

With TMS, it is possible to cause seizures (fits) in susceptible individuals using high intensity pulses.
With the lower strength pulses that we use, following agreed safety guidelines, seizures have not occurred. In the unlikely event of a seizure, you will be given appropriate medical treatment. The
DVLA have indicated that this would be regarded as a provoked seizure and would not affect the standard period of 1 month following a stroke during which driving is not permitted. The only other known side effect of TMS is headache, which goes away with simple painkillers. No long-term side effects of TMS have been described. Please tell the investigators if you or a member of your family has ever had seizures, fits or epilepsy.
All information which is collected about you during the course of the research will be kept strictly confidential. Any information about you which leaves the hospital / institute will have your name and address, date of birth and all identifiable information (including patient/hospital/NHS number) removed so that you cannot be recognised from it. The information held would include a brief summary of your symptoms and of your medical history and the results of the assessment outlined above.
The ‘data controllers’ (i.e. the organisations collecting, storing, handling and processing the information) would be the National Hospital for Neurology and Neurosurgery and the Institute of
Neurology.
As principal investigator, Dr Ward would be responsible by law for the safety and security of this information. No other organisations would have access to the data without his permission and if this were allowed it would be in a coded form (so that the identity of the patients involved would remain anonymous).
After the research study has finished, the information about you that has been collected will be retained indefinitely. It will be securely stored in a way that does not allow you to be identified.
It is important that your GP is aware that you are taking part in a research project. With your permission, your GP would therefore be informed by letter on a strictly confidential basis.
The tests used in this study are currently research tools only and of uncertain significance. They would therefore not affect you as an individual patient.
This project is being organised by the Institute of Neurology, in conjunction with the National
Hospital for Neurology and Neurosurgery. The costs of research (including researchers’ salaries and equipment) are being paid by The Stroke Association.
Information sheet – Neurophysiology of Fatigue After Stroke (NeuroFAST) Version 2, 15/10/2012

If you are harmed by taking part in this research project, there are no special compensation arrangements. If you are harmed due to someone’s negligence, then you may have grounds for a legal action but you may have to pay for it. Regardless of this, if you wish to complain, or have any concerns of this study, the normal National Health Service complaints mechanisms should be available to you. At this hospital the person to contact would be:
Ms Jennifer Fraser
Complaints Coordinator, Box 52
National Hospital for Neurology and Neurosurgery
Queen Square, London WC1N 3BG Tel: 0207 829 8765
We are close to Russell Square tube station, on the Piccadilly line. We can reimburse travel expenses for you and a companion, so keep any receipts you have to enable us to do this as quickly as possible.
This study has been reviewed by The National Hospital for Neurology and Neurosurgery and the
Institute of Neurology Joint Research Ethics Committee.
Thank you for taking the time to read this information sheet
Further information
If you would like to volunteer or would like to know more about the study, please contact
Dr Nick Ward
Sobell Department of Motor Neuroscience and Movement Disorders
Institute of Neurology
33 Queen Square, Box 146
London
WC1N 3BG
Telephone: 02034488762
For out of hours contact please ring Dr Nick Ward on 07974 820816.
Information sheet – Neurophysiology of Fatigue After Stroke (NeuroFAST) Version 2, 15/10/2012