Research: Cognitive Functioning in Multiple Sclerosis: A Longitudinal ERP Analysis

St Vincent's University Hospital, led by Professor Tubridy, Consultant Neurologist are asking you to participate in a research study. Your participation is entirely voluntary. You are being asked to participate in this study because you are a healthy volunteer (a ‘control’).

What is the purpose of this study?
The aim of the study is to examine brain activity and see how people with a diagnosis of Multiple Sclerosis (MS) complete a range of mental tasks, when compared to healthy control volunteers.

How long does the study take?
Your involvement in this study will take approximately 3.5 hours for the full assessment. However, because this is a follow-up study of people with MS, we are also asking control volunteers to return for a second assessment approximately one year after their initial assessment.

What does your involvement in the study entail?
For the assessment, you will be asked to attend St. Vincent’s Hospital on one occasion for 3.5 hours or twice in one week for shorter periods of time, if that suits you better.

Your involvement in the study involves the following four components:

(1) When you attend St Vincents Hospital, you will be asked to complete some mental tasks, for example addition of a series of numbers called out on CD.

(2) We will also record the electrical activity of your brain from the scalp surface. The method of recording electrical brain activity is called Electroencephalography (EEG), and it is a safe, non-invasive method. During a recording of brain activity, the subject listens to, and/or watches, some stimuli. These stimuli are called events, and the electrical activity associated with these events are called Event Related Potentials (ERPs).

The ERP test involves placing a cap with 128 electrodes on your head. Four electrodes will also be placed under and to the side of your eyes using sticky paper. Each electrode makes contact with the scalp via conductive water-based gel, which will have to be washed out afterwards. The picture below shows what the procedure will be like.

You will be asked to:

(a) Listen to a series of tones (beeps) through a pair of earphones, and press a button when you hear a high-pitched tone.
(b) Watch a series of letters on a computer screen, and press a button when you see the letter X.
(c) Watch a checkerboard pattern (no response needed)
(d) Listen to random noises (no response needed)
(e) Remember a series of numbers

(3) When you attend St Vincent’s Hospital, you will also be asked some questions about your mood and other aspects of mental health.

Some participants may find these questions somewhat disturbing or intrusive. If you experience any anxiety you will be offered a referral to counselling services provided by the Dept of Psychiatry at SVUH and UCD. The contact number is 01 2774228.

(4) Additionally, when you attend St Vincent’s Hospital you will be asked to undertake a neuropsychological assessment. This assessment will require you to complete a number of tests that will assess different aspects of your cognitive functioning (e.g. attention, concentration, memory).

Data Collection
The data collected as a result of your involvement in this study includes:
• Demographic information such as age, gender, and date of birth
• Information about your mood and mental health
• Neuropsychological tests data
• The data collected from the brain activity measure (ERP) described above
• Medical history data such as current medications and current and past medical conditions.

Are there any benefits from my participation?
You will not benefit directly from taking part in this study. The current study is part of a body of research that aims to examine the effects of MS on cognitive functioning. In time, it is hoped that the results of the current study, and of the studies that follow it, will contribute to the development of interventions that impact on MS. If you take part in the study, you will contribute to this body of research. Without people like you, the research would not be possible.

Are there any risks involved in participating?
We are using a very safe way of measuring brain activity, with no known adverse effects. Very occasionally, participants feel uncomfortable wearing the hat.

Who is organising and funding this research?
This study is organised by the Neurology research programme at St. Vincent’s University Hospital and University College Dublin, Ireland. There will be collaboration with colleagues at the School of Psychology in University College Dublin and the Schools of Engineering and Medicine in Trinity College Dublin. This study is partly funded by an Enterprise Ireland project grant titled eHealthCare based on Biomedical Signal Processing and ICT for Integrated Diagnosis and Treatment of Disease, and the Irish Research Council for Science Engineering and Technology (IRCSET).

Confidentiality
Every effort will be made to protect the names of the participants in this study. Specifically, each participant is given a unique study number that is used to identify their data in place of their name. Test data are stored with this number code only. Names of participants and their study numbers are kept in a locked filing cabinet in a locked office, as well as in a database that only the researchers can access. This information is stored separately from all test data.

For the purpose of this research, your name will never be used in any publication that may result from this study. However, there is no absolute guarantee that the information you provide will not be obtained by legal process or court order. Research data may be shared, as required by law, with St. Vincent's University Hospital authorities. Furthermore, if you give us information about the abuse or neglect of a minor or incapacitated adult, or make threat of harm to yourself or others, we are obliged to report this information to the relevant statutory authorities.
The data collected in this study will be used for the purpose described in this information leaflet. Unless otherwise specified, test data gathered from this study will be maintained indefinitely.

Anonymous data may also be shared with other researchers to conduct additional related studies.  This information will not identify you. Information that could identify you will not be released beyond that required for the purposes of conducting this research study, or as may be required by law (see above).

If you choose to withdraw from the study, you are entitled to take back your approval for the use of your data. To do this, you should contact the researcher in writing. Data that has already been collected will then be destroyed (unless we are obliged under law to disclose it to the relevant statutory authorities, or unless you agree to allow us use the data already collected).

These tests are being conducted for research purposes only. Therefore, it is not possible for participants to obtain any of the data collected.

Who should you call with questions about this study?
Sean O Donnchadha Postgraduate Research Room, E113 School of Psychology, Newman Building, University College Dublin. Call 089 4455937 or email  sean.odonnchadha@ucd.ie for further information.

What about the costs of the study?
There will not be a charge to you for any aspect of this study.

Will you be paid to participate in this study?
No

What happens if you get sick or hurt from participating in this study?
All appropriate emergency care will be provided in this instance.

'MS Ireland encourages research but participation on any research programme is at the clients own discretion. MS Ireland expects all clients considering research participation to assess its suitability.’