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Parental consent for MSI & HD-EEG in Clinical & Cognitive Neuroscience

TEXT TEMPLATE FOR PARENTAL CONSENT FORM

Investigational study: the use of magnetic source imaging and high density electroencephalography in clinical and cognitive neuroscience

BACKGROUND & PURPOSE

You are being invited to have your child take part in an investigational research study to help us learn more about the brain. 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 your child and anyone else you wish. Please ask us if there is anything that is not clear or if you would like more information. Take time to decide whether or not you would like your child to take part in this research study. Participation is voluntary.

This study is being done so we can study what the human brain does when a person moves, speaks, touches, smells, sees, or even thinks. Three types of measurements will help us to create a picture of the brain and a map of activity in the brain. The three technologies that we will use are: magnetoencephalography (MEG); high density electroencephalography (HD-EEG); and magnetic resonance imaging (MRI). Magnetic (MEG) and electrical (HD-EEG) information will be combined with anatomical (MRI) images as part of the data analysis to give maps of brain activity. The combination of MEG and MRI data gives maps of brain activity that are called magnetic source images (MSI); additional HD-EEG data can be used to refine these maps. Essentially, these MSI/HD-EEG maps can show what parts of the brain are active while the person experiences different types of stimuli. For example, they can show the different parts of the brain that respond when a person touches rough fabric, smells a rose, sees a friend’s face, hears a melody, or thinks about a summer vacation. The study is being conducted by PI name, and other qualified colleagues, staff and students that he selects to help him.

When an area of the brain is active, there is heightened electrical activity in that particular area. This activity also produces extremely small magnetic fields. MEG is a very sensitive measurement of these weak magnetic signals within the brain. HD-EEG is similar to routine clinical EEG, which measures the small electrical activity through small electrodes placed on the scalp; in comparison, HD-EEG uses more electrodes and a more complicated data analysis procedure than regular EEG. The HD-EEG measurement is sometimes referred to as “brain waves” and is often used in routine clinical neurology. The MRI machine uses strong magnetic fields to align the spinning of atoms in water molecules. It then creates an image of the brain and its activity from the tiny amounts of energy released when the atoms relax to their normal state.

MEG and HD-EEG can show when things are happening in the brain but are poor at showing for certain where they are happening. MRI can show well where things are happening but is less precise at showing when. The first purpose of this study is to investigate methods for making electrical and magnetic source images that show both when and where the brain is active. Combining MEG and/or HD-EEG measurements with MRI images will facilitate this goal.

In order to understand what is happening in the brain of a person who has a disease that prevents the brain from working as well, it is important for scientists to study people who are fortunate enough to have “normal” brain function. In addition, patients who have mental or physical problems having to do with brain dysfunction must be studied. The second purpose of this study is to compare and contrast the brain activity of these two groups using various stimulus conditions.

STUDY PROCEDURES

The study is divided in several phases of testing that may be performed on a single day or across different days, depending on how much time your child and the scientists have and also on when the MRI and MEG/HD-EEG equipment is available. All procedures are non-invasive, which means that they will occur outside of your child’s body, and there are no known risks.

Phase 1: Screening and evaluation

The first phase of testing is an evaluation that may involve no more than filling out a simple questionnaire concerning aspects of your child’s medical history related to brain function. (Example questions: “Has your child ever had a head trauma that rendered him/her unconscious?” “Has your child ever been diagnosed with autism or other psychiatric conditions?”).

If deemed appropriate, published, validated assessments will be used. For instance, if your child has experienced reading/language/speech difficulties, then one or more of the following tests would be used: Test of Language Development (TOLD), Comprehensive Test of Phonological Processing (CTOPP), Speech Perception in Noise (SPIN) test, Goldman-Fristoe-Woodcock (GFW) Test of Auditory Discrimination, and the Woodcock Reading Mastery Test (WRMT). It is expected that these tests would take a total of approximately 1 to 2 hours to complete. Assessments such as these would be necessary for correlating specific difficulties or experiences your child might have had with the map of your child’s brain activity (i.e., the MSI map completed after Phases 2 and 3).

Phase 2: MEG and HD-EEG imaging

The second phase of testing involves recording the brain’s electrical and/or magnetic activity under different stimulus conditions. In most cases both the MEG and HD-EEG will be performed; in some cases, only one or the other method may be used. None of this testing should be painful to your child and if he/she feels any discomfort, he/she will be able to and should let someone know immediately.

MEG and HD-EEG are measured at the same time during the same session. In order to do the HD-EEG, your child will be fitted with a specially designed electrode cap with 19-64 contacts (electrodes). The scalp under each electrode will be mildly rubbed with a sandy paste. This rubbing may cause some mild reddening of the skin and some discomfort that will not last for more than a few minutes. The paste can be washed out of your child’s hair easily with regular shampoo. More electrodes may be placed on your child’s ears and above and below your child’s eyes. Also, electrodes may be placed on your child’s chest, to monitor heartbeat. Also, four wire coils will be pasted to the scalp of your child. These are used to correlate the MEG/HD-EEG and MRI information. Removing these may pull your child’s hair slightly and cause some temporary discomfort.

The MEG examination uses a special sensor device known as a biomagnetometer. The device that records the HD-EEG is located within the same unit as the MEG. During the study, your child will be seated with his/her head resting inside the sensor unit, which feels like wearing a football helmet. Your child will need to try not to blink his/her eyes during the measurements. The session will last up to 3½ hours. This includes approximately 50 minutes of preparation time, during which electrodes will be placed as described above. Your child will be given a break from the MEG/HD-EEG examination every fifteen minutes and will be able to walk around, go to the bathroom, etc.

Phase 3: Magnetic resonance imaging (MRI)

MRI is recorded in a separate session lasting about 45 minutes to 1 hour. During the procedure, your child will lie on his/her back with his/her head in a hooplike magnet. Your child’s ears will be plugged to protect them from the loud noises made when the magnet fields change.

General procedures

During both MEG/HD-EEG and MRI sessions, there will be times when your child will be asked to sit quietly with eyes open or closed, to speak (speech production), or to make simple movements (motor production) in response to a stimulus. At other times, your child will be presented with sensory stimulus that may have to do with touch (tactile), sound (auditory), smell (olfactory, vomeronasal organ), sight (visual), or thought (cognitive). None of the stimuli will be painful to your child in any way. The auditory stimulus will be within a range that is comfortable and will in no way approach a level that damages hearing. At any point during the examination, you or your child will be free to tell us that either of you has decided that you don’t want to participate in the study after all. We understand, and you and your child should also understand, that your child’s participation in this study is entirely voluntary and you or your child may decide to withdraw at any time and without giving any reason.

RISKS

There are no known risks for neuropsychological testing (e.g., learning assessments such as TOLD, etc.), MEG, or HD-EEG measurements. The only known risk associated with MRI measurements is due to magnetic materials that are already in your child’s body. You must inform us if your child has anything implanted in his/her body, including such items as a metal plate or clip or a pacemaker. Your child may find it uncomfortable to hold his/her head still or to avoid blinking for long periods. As mentioned above, your child will receive breaks every 15 minutes during the MEG/HD-EEG portion of the examination.

Certain individuals feel intolerable claustrophobia during the MRI procedure. Claustrophobia is a feeling of not being comfortable within an enclosed space. If you think that your child will begin to or (at any time during the exam) is beginning to experience this uncomfortable or scared feeling from being within the enclosed space of the MR machine, your child will have other choices available to him/her. These include not having the MRI exam performed or traveling approximately 10 miles to an open MRI system specifically designed for individuals with claustrophobia.

If you have any questions regarding the procedures or the studies, please ask PI name, Co-PI name (Investigators listed on the front page of this form).

BENEFITS

Upon request, all imaging data and test results will be made available to you or your child’s physician. Otherwise, your child may expect no direct benefit from this research. Humanity may benefit if the information discovered in this study helps develop methods for the diagnosis and treatment of neurological and psychiatric diseases.

ALTERNATIVE PROCEDURES

PARTICIPATION IN RESEARCH IS VOLUNTARY. Your child’s alternative is to decline to participate in this study.

CONFIDENTIALITY

Any data about your child obtained from this research will be kept strictly confidential. Your child’s research records, just like hospital records, may be subpoenaed by Court Order. By signing this document, you agree to the review of data by the project investigators and also to the publication of study results (so long as the information is anonymous and/or disguised so that identification cannot be made).

PERSON TO CONTACT

If there are any questions that you or your legal representative may have regarding the examination, please contact PI name (office: 801-xxx-xxxx; cell: 801-xxx-xxxx).

INSTITUTIONAL REVIEW BOARD

If you have questions regarding your child’s rights as a research subject, or if problems arise which you do not feel you can discuss with the Investigator, please contact the Institutional Review Board Office at 801-581-3655.

MEDICAL TREATMENT OR COMPENSATION FOR INJURY

In the event that your child sustains an injury resulting from his/her participation in the research project, the University of Utah can provide to you, without charge, emergency and temporary medical treatment not otherwise covered by your child’s own insurance. If you believe that your child has sustained an injury as a result of his/her participation in this research program, please contact the Institutional Review Board, phone number: 801-581-3655. By signing this document you are not giving up your or your child’s right to pursue legal action against any and all parties involved with the research, in accordance with the Utah Governmental Immunity Act, Section 63-30-1:63-30-34 Utah Code Ann. 1953 (as amended).

VOLUNTARY PARTICIPATION

Your child’s refusal to participate in this study will not adversely affect your child’s health care. Your child may withdraw from the study at any time without penalty.

UNFORESEEABLE RISKS

Any new information forthcoming about possible adverse effects from the study will be relayed to you in a timely manner. The particular procedure described herein may involve risk, which is currently unforeseeable.

RIGHT OF INVESTIGATOR TO WITHDRAW SUBJECT

PI name may ask that your child withdraw from this study because of poor data quality, a complicating medical illness, or other unforeseen circumstances. It may be necessary to reschedule examinations if a clinical emergency requires use of the MEG or MRI machine.

COST/REIMBURSEMENT TO SUBJECTS

There will be no costs to your child for participation in the study. Your child will not be paid for participation in the study.

NEW INFORMATION

Any new finding(s) developed during the course of the research that may relate to your child’s willingness to continue participation will be provided to you and/or your primary care physician. For example, if a scientist discovers new information about MEG, we will let you know what has been discovered, so that you and/or your doctor can decide whether or not the study is right for your child.

NUMBER OF SUBJECTS

Approximately 1000 subjects will be recruited over the duration of the study.

VOLUNTARY CONSENT