Part 1 of this document explains 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.
PART ONE
What is the purpose of the study?
Chronic fatigue syndrome (CFS) can be very disabling for sufferers but the search for better treatments is handicapped by lack of knowledge about the brain biochemistry that underpins important symptoms such as exhaustion, poor memory and concentration and impaired sleep.
Advances in magnetic resonance imaging (MRI) mean that it is now possible to measure brain structure and function non-invasively. Magnetic resonance spectroscopy (MRS) is a form of MRI which is able to measure brain biochemistry and we have access to a new, advanced MRS system at the John Radcliffe Hospital at the Oxford Centre for Functional Imaging of the Brain (FMRIB) (
www.fmrib.ox.ac.uk). The aim of this pilot study is to use this new MRS system to examine brain chemicals in people with CFS, focusing particularly on a chemical called lactate which is involved in energy production in cells and which can be measured with modern MRS systems.
Research studies have also noted a relationship between the immune system (how the body reacts to an infection) and the development of mood symptoms. For this reason we wish to take an optional blood sample.
Participants
We are asking you to participate as someone who has a history of CFS. Altogether we plan to study 12 people with CFS, 12 with bipolar disorder and 16 healthy controls in this investigation.
Do I have to take part?
No, this is a research study so it is completely up to you whether or not to take part. If you agree to take part we will give you this information sheet to keep and will ask you to sign a consent form. Even if you agree to take part you can withdraw from the study at any time without giving a reason and without any effect on your current or future treatment.
What will happen to me?
Below we describe the main parts of the research study:
Consent and screening
For the screening visit we would like you to come to the Neurosciences Building at the Warneford Hospital. Here, we would ask you some questions about your general health and your mood over the last few years. This would take the form of an interview. We would also like you to complete some questionnaires about mood, anxiety and energy levels. Altogether this would take about 60-90 minutes.
If from this interview you are eligible to take part in the study and agree to do so, we will ask you to sign a consent form saying that you understand the study procedures and agree to take part in the study. You may want some time to think about participating and you can take up to two weeks to decide if you want to take part. The consent will take place at the Neurosciences Building at the Warneford Hospital and will be taken by one of the study investigators listed at the bottom of this letter.
Optional Blood Sample
On the screening or MRS visit, whichever is most convenient, we wish to take a small blood sample, about 20 ml, or the equivalent of 4 teaspoons, from you to measure markers of inflammation. Possible side effects of blood taking (venepuncture) are discomfort and bruising, dizziness and possibly fainting. Only one sample is taken during the study and any sample remaining following the planned analysis is destroyed.
MRS scanning
The MRS scanning will take place at the Oxford Centre for Functional Imaging of the Brain (FMRIB) at the John Radcliffe Hospital on a separate day and will be within about two weeks of the screening interview. There is only one scan and it will take about 60 minutes. We are hoping that the scan will give us important information about the levels of lactate in the brain in bipolar disorder and CFS relative to healthy controls.
The scanner is a large cube shape. Running through the middle of the scanner is a tube, which is open at both ends. You will enter the scanner head-first and your feet will remain outside the tube. During the scan you will hear some tapping and bleeping noises. The radiographer and researcher will be able to see you throughout the scan and we will provide you with a call button, which you can press at any time if you want to come out of the scanner. The scanner makes a loud knocking noise when it is running, and therefore participants will be provided with earplugs and protective headphones during the scan. There are no known risks of MRS scanning provided standard safety guidelines are followed carefully.
What will I have to do?
The main requirement is to attend the appointments and brain scanning when arranged. Once you have completed these visits, your participation will end in the study.
What are the possible disadvantages and risks of taking part?
MRS scanning is safe and non-invasive and does not involve any ionizing radiation (xrays). However, because it uses a large magnet to work, MRI scans are not suitable for everybody. Because of this, you will be asked pre-screening safety questions to help determine if you are able to take part. For example, if you suffer from claustrophobia, you could not be scanned. Normally, MRS scanning for research purposes would not be performed without further investigation if you have a heart pacemaker, mechanical heart valve, mechanical implant such as an aneurysm clip, hip replacement, or if you carry other pieces of metal that have accidentally entered your body.
While there is no evidence to suggest that MRI is harmful to unborn babies, as a precaution, the Department of Health advises against scanning pregnant women unless there is a clinical benefit. We do not test for pregnancy as routine so if you think you may be pregnant you should not take part in this study. As some of the scans are noisy, we would give you earplugs, head padding or headphones to make this quieter for you. It is important that these are fitted correctly as they are designed to protect your ears. In preparation for your scan and for your comfort and safety we may ask you to change into pocket-less and metal free "pajama-style" top and trousers, which are available in a range of sizes. You may keep your underwear and socks on but we would ask ladies to remove underwired bras, if you have a suitable sports type bra you may wear this instead. Please avoid any fabrics that contain metallic threads or have been silver impregnated (often marketed as anti-microbial/bacterial or anti-odour).
Metal jewelry including body piercing must also be removed. Eye shadow and mascara must also be avoided, since some types contain materials that can interact with the magnetic field. If you wish to wear eye makeup to your scan we can provide makeup removal wipes but you are advised to bring your own makeup to reapply. Lockers are provided to secure your personal belongings and clothing. Some people scanned in MRI scanners, especially 7 Tesla scanners, may experience a mild dizzy sensation as they are moved into the scanner. This is normal and the sensation starts to go away as soon as you are in the scanner.
It is important to note that we do not carry out scans for diagnostic purposes, and therefore these scans are not a substitute for a doctor’s appointment. Our scans are not routinely looked at by a doctor; rather our scans are intended for research purposes only. Occasionally a possible abnormality may be detected. In this case, we would have the scan checked by a doctor. If the doctor felt that the abnormality was medically important, you would be contacted directly and recommended to have a hospital (NHS) diagnostic scan arranged. All information about you is kept strictly confidential.
What are the benefits of taking part?
The study will not be of direct benefit to you but we hope that the information we obtain will help improve the understanding and later the treatment of CFS.
Will my taking part in the study be kept confidential?
Yes. We will follow ethical and legal practice and all information about you will be handled in confidence. The details are included in Part 2.
If the information in Part 1 has interested you and you are considering participation please read the additional information in Part 2 before making any decision.
PART TWO
What will happen if I don’t want to carry on with the study?
You can leave the study at any time, including during the scan itself. If you withdraw before the MRS scan is completed all your screening data will be destroyed.
What if there is a problem?
The University of Oxford, as Sponsor, has appropriate insurance in place in the unlikely event that you suffer any harm as a direct consequence of your participation in this study. If you wish to complain about any aspect of the way in which you have been approached or treated during the course of this study, you should contact either Dr Beata Godlewska (01865 618309,
beata.godlewska@psych.ox.ac.uk) directly or you may contact the University of Oxford Clinical Trials and Research Governance (CTRG) office on 01865 572224 or you can email the head of CTRG,
ctrg@admin.ox.ac.uk.
Will my taking part in the study be kept confidential?
Your data will be collected by clinical researchers and anonymized which means that it will be coded and only the study investigators will be have access to the code. All the investigators have a duty of confidentiality towards you exactly as in usual medical practice. Responsible members of the University of Oxford, or the Oxford University Hospitals NHS Trust may be given access to data for monitoring and/or audit of the study to ensure we are complying with regulations.
Anonymized study data will be stored for ten years and then disposed of securely unless we obtain further ethical committee approval to use it in a subsequent study. Your anonymized scan data might be shared with other bona fide researchers so that the maximum value of your contribution can be realized. However, no researchers outside the immediate research team will have access to any personal information about you and it will not be possible to link the scans to any particular individual.
What will happen to the results of the research study?
We hope to publish the results of the study in the scientific literature. You will not be identified in the publication. The results of the study will also be made available on our Departmental Web-site (
http://www.psych.ox.ac.uk/research/psychopharmacology).
Who is organizing and funding the research?
The University Department of Psychiatry is funding the study and the research is being sponsored and organised by the University of Oxford. No payment is made to either the doctors conducting the research or the hospitals where this research is carried out if you were to decide to help with the study.
Expenses and payments
We will reimburse any expenses you incur taking part in the study (for example, travel expenses) and will also offer a payment of £50 to all participants who have the MRS scan and interviews as reimbursement for time and inconvenience.
Who has reviewed the study?
All research in the NHS is looked at by independent group of people, called a Research Ethics Committee to protect your safety, rights, well being and dignity. This study has been reviewed and given favourable opinion by the Research Ethics Committee South Central-Oxford A.
Thank you for reading this information sheet. If you have any questions please get in touch with Dr Beata Godlewska (tel: 01865-618309 or
beata.godlewska@psych.ox.ac.uk)
Dr Brian Angus (
brian.angus@ndm.ox.ac.uk)
Professor PJ Cowen (
phil.cowen@psych.ox.ac.uk)
Dr Beata Godlewska (
beata.godlewska@psych.ox.ac.uk)
Dr Ann Sharpley (
ann.sharpley@psych.ox.ac.uk)
Ms Clare Williams (
clare.williams@psych.ox.ac.uk)