FMRI (functional magnetic resonance imaging) Social Competence and Neuroimaging

MICHIGAN STATE UNIVERSITY, DEPARTMENT OF PSYCHOLOGY

CONSENT TO ACT AS A RESEARCH SUBJECT

Investigators

Margaret Semrud-Clikeman, Ph.D., Professor in Psychology and Psychiatry, and Jodene Fine, Ph.D. Post-doctoral Fellow, from MSU, and their associates are conducting a research study to learn more about the workings of the brain during viewing of faces, hearing voices reading sentences, and vignettes of children. We are trying to learn the best ways to evaluate children suspected of having difficulties with social skill development as well as those who do not have such problems. More importantly, however, we are looking for better and more effective ways for parents and teachers to help students with social skill problems. We are asking parents of children who do not have these problems to participate in this study to determine how these children differ from children who do have social competence difficulties. We are also asking parents of children with such difficulties to participate in our study. Your child will be one of several children asked to participate in the project over several years. You and your child’s participation in this study is voluntary and can be revoked at any point.

Procedures to be followed during this study

The total amount of time required for this study is six hours. There are two parts to this study. First, we will conduct an assessment to determine whether your child has social skills difficulties or not. Your child will be asked to define words, solve problems, read and complete mathematics problems, complete block designs, write and draw, complete puzzles and answer questions about his/her feelings. Your child will also be asked to identify the emotions shown on computerized program. This assessment will take place in the Psychiatry Department at Michigan State University. The results of this screening will be provided to you in a brief report. We will also ask you to have your child’s teacher complete rating scales that you will be provided. Parents will also be asked to complete an interview as well as behavioral rating scales and a developmental history.

On another day, approximately one hour will be spent in an MRI scanner. This session will take place at the Radiology Department and Clinical Center at MSU. This session will involve lying quietly inside the center of a large doughnut-shaped magnet (the MRI scanner) while we take images of your child’s brain structure and function. You may watch from the control booth if you wish. While in the scanner, your child will be asked to view a series of pictures of faces (happy, sad, neutral), then listen to a child read sentences in various emotions (happy, sad, neutral) and then view a DVD of children playing or talking.

If you agree for your child to participate in this study the following will happen:

MRI scanning

We will first make sure that your child does not have any risk factors for participating in the fMRI part of the study. For example, we will ask you if your child has a pacemaker, any metal pins, or other metal in his/her body such as metal pins in artificial joints or body piercing that cannot be removed. We cannot scan anyone who has a pacemaker or metal in their bodies. To conduct the scan your child will be asked to lie on his/her back on a firm but comfortable "bed" which is actually a movable dolly on tracks. Your child’s head will be placed in a special helmet-like "head holder," and to keep the head still we will place foam pillows around your child’s head. The scanner makes a loud noise while taking pictures of your brain, so you will be given earplugs to wear throughout the scan except when listening to sentences when your child will wear headphones.

Before your child enters the MRI, we will have a chance for him/her to use the "Mock Scanner". This is a pretend scanner that allows him/her to become comfortable with the procedure and is used to help the child feel less anxious. We will practice in this mock scanner until he/she feels comfortable. You can be with your child in this room. After your child is placed in the scanner we will first take pictures of your child’s brain structure or anatomy. This will take approximately 15-20 minutes. During this time we will invite your child to bring a favorite DVD to watch to help pass the time. Next, we will take pictures of your child’s brain activity while your child watches a series of images, such as faces or shapes, on a screen mounted above his/her eyes. Following this portion your child will listen to sentences through headphones. Finally your child will watch a DVD of scenes of children acting out various activities. Each of these portions of the study will consist of several "runs" in the MRI scanner, each lasting approximately 5-7 minutes. Finally, during the scanning we will ask your child to determine whether there were boys or girls in the pictures and voices. Your child will use a button box positioned under one of his/her hands. This portion of the study will take approximately 45 minutes. Your child will be in the scanner for a total of about 1 hour.

While your child is in the MRI scanner, your child will lie on his/her back on the scanner bed. Your child may wear whatever clothes she/he likes, and to be more comfortable your child may want to take his/her shoes off. Because the electromagnet creates a strong magnetic field, your child may not take any metallic or magnetized objects into the magnet room. That includes keys, metal jewelry, wristwatch, or a belt with a metal buckle, and also credit cards. We will provide a safe place for your child to store those possessions during the experiment.

Getting into the MRI scanner involves two phases: first, your child will lie on the bed; then, after we help your child adjust pillows under his/her head and legs so that he/she is completely comfortable, the "bed" is rolled into the magnet. Only the upper part of your child’s body will be inside the scanner. The space around your child’s head will be quite restricted, but nothing will touch your child’s face.

Are there Any Risks Associated with Participation in this Study?

Magnetic Resonance Imaging (MRI) is different that other scanning techniques used to measure structure and function of the brain. Other techniques, such as conventional X-ray, computed tomography (CT), or positron emission tomography (PET) use radiation generated by an X-ray machine or by chemical tracers. MRI does not use penetrating radiation. Instead, it uses a combination of radio frequency waves and a strong magnetic field generated by a large electromagnet to detect the distribution of hydrogen atoms in living tissues. Computers are then used to reconstruct the weak signals given off by the hydrogen atoms into high-quality anatomical images.

In summary, MRI presents no risks from ionizing radiation because no ionizing radiation is used. The magnetic coil that we will be using is approved by the Food and Drug Administration (FDA) for routine clinical uses, as well as for research purposes. There are, however, several other risks associated with the use of MRI. They are:

1) If the researchers or the participant are carrying any loose metallic objects, such as keys, these can be released in the vicinity of the magnet, and cause impact injuries;

2) For individuals wearing pacemakers or metallic prostheses, the magnetic field can induce electric currents in implanted wires in those devices;

3) For individuals with artificial joints, such as hip joints, the magnetic field can displace the metallic components (e.g. metal pins in the case of artificial joints) in those devices;

4) For individuals with electromagnetically programmed pacemakers, the magnetic field can erase the program code in these devices.

We ensure that the 1st hazard is eliminated by removing all metallic objects (keys, watches, and the like) from the researchers and from you before the MRI experiment begins.

To eliminate the 2nd, 3rd, and 4th hazards, we do not allow anyone to participate who is wearing a pacemaker, neurostimulator, or any other implanted device.

If you are injured as a result of your participation in this research project, Michigan State University will assist you in obtaining emergency care, if necessary, for your research related injuries. If you have insurance for medical care, your insurance carrier will be billed in the ordinary manner. As with any medical insurance, any costs that are not covered or in excess of what are paid by your insurance, including deductibles, will be your responsibility. Financial compensation for lost wages, disability, pain or discomfort is not available. This does not mean that you are giving up any legal rights you may have. You may contact Dr. Margaret Semrud-Clikeman or Dr. Jodene Fine with any questions.

We want to mention three other possible risks. Certain individuals may feel "claustrophobic’ once they are in the magnet. If you don’t think that your child is likely to be one of those persons, then in all likelihood your child won’t be. But, if after going into the magnet, you feel uncomfortable and want to stop the experiment, you or your child can tell us, and we will immediately stop the experiment and let you and your child decide whether or not you and your child want to continue (see the section below on Your Rights as a Participant in an Experiment). Also, a small number of subjects perceive some dizziness as they are being moved into the scanner because they are passing through a magnetic field. This is completely harmless, but we will ask your child to please tell us if you feel dizzy, and if you or your child doesn’t want to continue you and your child may of course stop at any point. Although there is no data that indicates harm to a fetus from a MRI scan, we will screen all females above the age of 13 for possible pregnancy.

What If the MRI Reveals a Structural Abnormality in Your Brain?

There is one other consideration that we want to bring to your attention, and that is, what would we do if the scan of your child’s brain reveals a structural abnormality of some kind? Looking for abnormalities is not the purpose of this research. Furthermore, many structural abnormalities are not clinically significant. These scans are reviewed by a licensed radiologist. If something abnormal and potentially clinically significant shows up in your child’s case or if your child is pregnant, we are ethically bound to inform you, or if you prefer, your primary care physician. If you would want us to inform your physician, please indicate his or her name and address (if you know it) in the space below. If you would rather we inform you, you do not have to write down anything.

_________________________________________________

(Physician’s name / address)

Benefits of the Study

There may or may not be any direct benefit to you from this study, but we hope to learn more about how the brain functions, thereby gaining knowledge that may help others in the future.

Credit/Payment for Participation

Children and adolescents who pass the pre-scanning evaluation will be paid $40 for each MRI session in which they participate and $60 for the assessment. You will not be charged for any tests or procedures required for the study. You may be asked if you are interested in participating in future studies.

Your Rights As a Participant in this Experiment

As a participant in an experiment, you have certain rights of which you should be aware:

1. First, even if you agree to have your child participate, you have the right to change your mind and to not participate before the experiment begins, and to do so without penalty. Participation in this study is voluntary.

2. Second, even if you agree for your child to participate and have begun the experiment, you have the right to discontinue your child’s participation at any time and for any reason, and to do so without explanation or penalty. This will be the case whether you decide to discontinue participation during the first part (completing the assessment) or the part performed at the MRI Center. If you decide to discontinue participation, all information about you will be destroyed, and your name will be deleted from our records.

Your participation may be ended without your consent if:

a. the investigator believes that it is in your best interest.

b. the project is terminated.

c. you no longer meet study criteria.

3. Third, you have the right to confidentiality. To ensure this, your child will be assigned a subject number, which will be the only way to identify your child in any reports about the study. Only the experimenters will have access to files and lists that can be used to link a name with a subject number. All files will be in a locked file cabinet for which only the principal investigators have access. You and your child’s privacy will be protected to the maximum extent allowable by law.

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If at any time you have questions about your rights as a research subject, you may contact Peter Vasilenko, Ph.D., Director of Human Research Protections, (517)355-2180, fax (517)432-4503, e-mail irb@msu.edu, mail 202 Olds Hall, Michigan State University, East Lansing, MI 48824-1047.

Questions About the Study

Finally, after the entire study is completed, if you have any questions or if you would like a written summary of the general results, you are invited to contact the investigators at their University offices (Dr. Semrud-Clikeman: (517) 432-2309, semrudcl@msu.edu; Dr. Fine: (517) 353-5035, finej@msu.edu.

Signature and Acknowledgment

I have received a copy of this form.

I have read this consent form and I voluntarily agree for my child to participate.

Subject Name (Please Print)

Signature of Parent/Guardian Subject’s Date of Birth Today’s Date

For Children and Adolescents 13 and older

I have read this consent form and I voluntarily agree to participate. If I decide to quit the study, all I have to do is tell the person in charge.

______________________________ _________________

Signature of Child/Adolescent Today’s Date

Signature of Investigator or Assistant Today’s Date

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B. Assent form for child between the ages of 6 and 12.

 

ASSENT FORM

Study of the Brain’s Responses to Faces, Voices, and Scenes

This study is designed to understand how children understand children’s emotions and friendships. You will see pictures of children showing different facial expressions as well as playing with others. The only people who will know about what you say and do in the study will be the people in charge of the study and your parents.

In the study you will be asked questions about how you solve problems and answer questions. You will also work with block designs, draw, and work on a computer. You will also be asked how you feel about yourself and your friends. On another day you will lie in a machine that takes pictures of your brain. This does not hurt but can be boring. You will watch a DVD, look at faces of other children and listen to sentences using headphones. You will be asked to push a button to tell whether there are boys or girls in the pictures or boy or girls talking.

Writing your name on this page means that the page was read (by you/to you) and that you agree to be in the study. If you decide to quit the study, all you have to do is tell the person in charge.

__________________________________________ __________________

Child's Signature Date

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