Research Areas: Multiple Sclerosis
Investigators: Dr Saad Ramadan, A/Prof Jeannette Lechner-Scott, Dr Karen Ribbons and Mr Oun Al-Iedani
You are invited to take part in a research study, as a healthy control participant, in a research study aimed at gaining a better understanding Multiple Sclerosis (MS).
Proton magnetic resonance spectroscopy (MRS) is a non-invasive technique that enables us to examine changes in chemicals in the brain. This method will increase our understanding of chemical mechanisms involved in changes in cognitive function, weakness problems and memory loss associated with the neurological diseases. This project will apply new techniques to evaluate biochemical changes in the whole brain that may impact on learning and memory function, fatigue and mood changes in people with relapsing remitting multiple sclerosis (RRMS). Participation by healthy control subjects will allow us to compare normal brain anatomy in healthy individuals with that seen in RRMS.
The information below explains the research study and the tests involved. Knowing what is involved will help you decide if you want to take part in the research. Read this information carefully. Ask questions about anything that you don’t understand or want to know more about. Before deciding whether or not to take part, you might want to talk about it with a relative, friend or your local doctor.
Participation in this research is voluntary. If you don’t wish to take part, you don’t have to. You will receive the best possible care whether or not you take part.
If you decide you want to take part in the research study, you will be asked to sign a consent form. By signing it you are telling us that you:
- Understand what you have read
- Consent to take part in the research study
- Consent to have the tests that are described
- Consent to the use of your personal and health information as described
You will be given a copy of the Participant Information Statement to keep.
What is involved?
You will be asked to attend the Hunter Medical Research Institute (HMRI) on one occasion to carry out a number of procedures and reviews that may take roughly 2 hours to complete. These are explained below:
MRI (Magnetic Resonance Imaging): During this study, a Magnetic Resonance Imaging (MRI) scanner will be used to acquire MR data and images of your brain based on electromagnetic radiation (radio waves) in a strong magnetic field. The MRI scanner will also provide information about the changes in structures and chemicals in your brain. You will lie on a table and your body will be placed in a hollow tube that is inside a large magnet. You will be asked to lie still during the procedure. In order to help keep your head still, foam pillows may be placed under and around your head. In order to protect your ears from the loud sounds of the MRI, you will wear earplugs during imaging. You will hear repetitive loud noises (banging) for a short period of time. If you do experience discomfort at any time during the scan, you will be able to communicate with staff at all times. Each scan will last approximately 60 minutes and will take place at the Imaging Centre at the Hunter Medical Research Institute.
Learning and Memory Assessments (Cognitive function testing): You will be asked to complete 2 written tests that will be used to evaluate your learning and memory abilities. The Symbol Digit Modalities Test (SDMT) involves writing down responses to a decoding task and takes approximately 3 minutes. During the second test, the Audio Recorded Cognitive Screen (ARCS), you will be prompted by a recorded voice to complete a series of tasks by writing your responses in a booklet. This will take approximately 35 minutes to complete. You will also be asked to provide information about your age, sex and educational background. As your mood status and level of tiredness impact on your learning and memory functioning, self report questionnaires relating to your mood, The Depression Anxiety Stress Scale (DASS), and level of tiredness, The Modified Fatigue Impact scale (MFIS) will also be administered at this time. You will also be asked to complete a questionnaire that asks for your impression of your learning and memory abilities, the Functional Assessment Questionnaire (FAQ).
When will I see a result?
Each participant can, if they so wish, see their own results or received any published material that has been presented in a medical journal. This will, however, have no bearing with respect to your medical care as these will be research results that if significant would require additional independent studies from other researchers around the world.
All scans and Information will be de-identified for analysis and end results will be published in a medical journal. Medical records identifying you will be kept strictly confidential. Your data will be identified by a code and only authorized researchers will be able to decipher the code. The information will only be used for the purpose of the study. Information will be stored under secure conditions for 15 years, after which they will be destroyed.
Your health records and any information obtained during the study are subject to inspection by Hunter New England Human Research Ethics Committee. Your personal information will be accessed, used and stored in accordance with commonwealth privacy laws, and the NSW Health records and information privacy act 2002. By signing the attached Consent Form, you authorise release of, or access to, this confidential information to the relevant study personnel and regulatory authorities as noted above.
What are possible risks or benefits of taking part?
As a study participant, there will be no direct benefit to you in participating in this research, but it is hoped that the information obtained from your participation in this study, will provide valuable information about MS.
There are no known risks associated with participating in an assessment of your cognitive and mood functions. There are also no known or foreseeable risks or side effects associated with conventional MRI procedures, except to those people who have electrically, magnetically or mechanically activated implants (such as cardiac pacemakers) or to those who have clips on blood vessels in their brain. If you have any of the above implants, or are claustrophobic (i.e. have an abnormal dread of being in close or narrow spaces), then you are not suitable for this study. System safeguards and screening procedures have been designed and operating guidelines have been provided to minimize any possible risks. Your comfort will be verified periodically during the study, but should you become distressed while lying in the MRI scanner, the health care specialist working with you at the time can provide information and advice regarding additional support and/or referral for your particular concerns. You may find the MRI procedure mildly uncomfortable, but there is no serious risk or harm associated with this procedure. You can withdraw from the scan at any time with no need to give a reason and without any liabilities. You will be provided with hearing protection (earplugs), which will prevent due to scanner noise. There will be no cost associated with participation in this study.
Further Information or Any Problem
If you are interested in this study, require further information or if you have any problems concerning this study, please contact one of the investigators below:
Dr. Karen Ribbons – email firstname.lastname@example.org or phone (02) 4042 0332