The goal of this study is to understand how the brain develops throughout infant and early childhood (3 months to 5 years of age) in children born with severe or profound deafness.

We are inviting families to participate in a Brown University research study of brain development throughout infancy and early childhood in children born with severe or profound bilateral or unilateral hearing loss. 

The study involves taking pictures of children’s brains using a magnetic resonance imaging (MRI) scanner, coupled with evaluations of general functional development (including language, motor control, visual reception. and social and emotional processing).  Participants will be invited to attend up to 4 imaging and functional assessment sessions over the course of 3 years.  This data will allow us to investigate a specific process of brain maturation, called myelination, and better understand the relationships between myelination and functional development in children born with hearing loss.

Broadly, brain tissue can be classified as either white matter or grey matter.  White matter is comprised of fibers, which carry information between the grey matter areas containing neurons where that information is processed. Myelin, a fatty layer that surrounds these white matter fibers, acts like an electrical insulator and increases the speed information is carried throughout the brain.  Myelin, therefore, is critical for normal and efficient brain function and is a crucial element of brain development.  Despite the critical role of myelin in brain function, the process of myelination in children born with hearing loss is not well understood, and its relationship to other developmental processes (i.e., learning, language, hand-eye coordination) remains unknown.

Before you decide to participate, it is important to fully understand why the research is being done, and what you and your child’s participation will involve.  Please take the time to read the following information carefully.  Members of the imaging team will additionally go through this information with you to answer any questions or provide clarification if needed.

Can My Infant / Toddler Participate?

Yes! If your child:

- Was born at term (37-41 weeks) without major complications during delivery.

- Was born with severe or profound unilateral or bilateral hearing loss.

- Is healthy and has normal vision.

- Has no metal in his / her body.

1. -Is between 2 months and 6 years at the time of study enrollment.
   

What Is The Aim Of The Study?  What Are We Expecting To Learn With This Research?

Myelin is a crucial component of brain structure.  Myelin is a fatty substance that surrounds brain axons and allows rapid and co-ordinated brain messaging, facilitating coordinated movement, language, decision making, etc.  While the development of myelin is influenced by both genetic and environmental factors, little is known how this process proceeds in children born with hearing loss, or how this relates to language and emotional development in hearing-impaired children.  The aim of this study is to address these fundamental questions.  We hope to increase our understanding of how the brain developments and how the structural process of myelination corresponds to cognitive and functional development.  Knowing how the brain develops and responds to environmental conditions and learning is an important step towards understanding what happens in children with developmental disorders, including autism and developmental delay.

As neurodevelopment and myelination is a continuous process, the study is longitudinal in nature, comprising up to 4 imaging and functional evaluation sessions (depending on age at enrollment) over the course of 3 years with an option to continue until your child reaches age 11.  Acquiring data longitudinally will allow us to better determine how the brain develops over time.

What Will Each Session Involve?

There are two separate sessions involved in this research – the MRI scan and the functional assessment. All data will be stored securely and information will be anonymised. You will be reimbursed for your time and travel.

MRI scanning session - When we contact you, we will ask about your child’s age in order to place them in the appropriate age category. 

Children under age four will normally be scanned asleep and so we will ask about your child’s usual sleeping pattern and daily routine.  The MRI session will be performed near your child’s normal nap or sleep time during their natural sleep (non-sedated). All imaging sessions will take place at the MRI facility at Brown University, with your child in the scanner for up to 30 minutes. We will ask you to come to the center about 2 hours before their regular nap or sleep time, so that there is plenty of time to settle you and your child in the center and explain the procedures. We have a nappy changing station and a quiet room for feeding and relaxing so that your child can fall asleep undisturbed.  As soon as your child starts showing signs of falling asleep, we will loosely swaddle and place them on the scanner table (outside of the scanning room).  Once their are in deep sleep, we will place Minimuff ear cushions and headphones over their ears to protect their hearing, tighten the swaddle a little and place soft foam wedges around their body to make sure they are comfortable and do not move during the imaging session.  The scan typically lasts up to 30 minutes, but may need to be extended if you child wakes up and needs to be repositioned. If your child awakens during the scan, but remains calm and content, we will try to finish the scan session.

For older children who can be imaged while awake, we will ask you to come to the MR facility about 30 minutes before their scheduled scan time.  We may place your child in a ‘mock’ scanner to familiarize them with the environment if necessary.  Once comfortable, we will move them to the MRI scanner suite, position them soft foam wedges around their body to make sure they are comfortable and do not move during the imaging session.  The scan typically lasts up to 30 minutes, but may need to be extended if you child moves or needs to be repositioned.

We have worked hard to minimize the sound of the MRI scanner, making it near silent.  There is a microphone and camera inside the scanner so that we can hear and see your child throughout the scan session.  If you choose, you may stay with your child in the scanner room.  Before entering the scanning room, we will screen you for metal and other MR contraindications and provide you with hearing protection. You can stop the study at any time.  If you think your child is unhappy or distressed, inform us and we will stop.

Functional assessment session - Depending on your child’s age, a set of standardized tasks designed to assess your child’s language, motor control and vision will be performed. These tests will require between 30 minutes (for younger children) to 120 minutes (for the older children) to complete.  They will be administered in a play-like atmosphere.  For older children, we ask that you also complete questionnaires aimed at investigating social-emotional processing and executive functioning (i.e., ability to organize information). Since development is a rapid process in young infants and toddlers, we would like to perform functional assessments within 7 days of your child’s MRI at a time that is convenient for you.  We will also give you parental questionnaires to complete regarding your child’s behavior.  These may be completed during the assessment or taken home to be completed.  We will provide a self-addressed and stamped envelope to return them if you take them home.

At the same time as the assessments, we may also obtain a genetic (DNA) sample from your child.  This process is painless and involves no blood draw.  We will rub your child’s inner cheeks and gums for 20 seconds with three (3) sterile, cotton-tipped swabs (like Q-tips).  We will then place the swabs in a container filled with a liquid preservative.  This part of the study is entirely optional, and you are free to consent to this part of the study or not at the end of this form. 

We may also collect an EEG recording, which measures electrical activity in the brain. This process is painless and involves placing a net of small soft pads on the head. These pads are made up of small plastic tubes with sponges placed on the child’s head by the experimenter.  Your child will sit on the your lap or be in the immediate range of you for the duration of the recording (about 30 mins). It takes a further 15 minutes to apply the EEG pads.

You are free to consent to this part of the study or not at the end of this form. If choose to take part, the EEG recording will occur on two of the visits and you are free to withdraw at any time. Depending on the age of your child, your child may be cuddled on your lap or may play with a toy.

Is MRI Safe For My Child?

MRI is a safe and non-invasive technique that is commonly used to study the brain in children and adults.  It does not involve radiation.  Instead, the MR scanner consists of a powerful magnet, which may attract certain metallic objects.  If your child has metal pieces in his/her body (for example, following an operation), they should not be scanned. 

How Long Will Each Session Last?

The functional assessments will last between 30 to 120 minutes.  The scan will last up to 30 minutes.  The whole session, including preparation time, feeding and settling your child may take up to 3 hours.  You are free to end the session, for any reason, whenever you wish. 

How Should We Prepare For The Session?

We are scanning children during their natural sleep, without any type of sedation.  It is important that we schedule the session around your child’s naptime, so that he/she falls asleep at the center. Since we will wait for your child to fall asleep, you may be in the center longer than 3 hours.  Prior to your first visit, we will provide you with a tape/CD/DVD with the sounds of the MR scanner running the protocol we will use during your visit.  If possible, we ask that you play this as your child is falling asleep or napping during the week preceding your visit to help them become accustom to the sound of the scanner.

Where Do The Study Sessions Take Place?

The study sessions will take place at the MRI facility at Brown University (185 Meeting Street, Providence RI, 02906).  Imaging will be performed on a 3 Tesla (3T) Siemens MR imager. The functional assessment will be carried out in a dedicated playroom at 97 Waterman Street (Arnold Lab, near the intersection of Waterman and Thayer Streets), Providence RI.

How Many Times Will My Child Be Scanned?

The study involves up to 4 scans over a 2-3 year duration. Children under the age of 3 will be scanned up to 4 times over a 2-year span (i.e., once every 6 months). Children older than 3 years will be imaged once per year.

To familiarize you and your child with the scanner environment, an additional session in a ‘mock’ scanner will be booked on a separate day prior to your first actual scan visit.  Although the mock scanner looks and sounds like a real MR imager, it does not have a magnetic field or the equipment necessary to record data.

What Do I, Or My Child, Gain By Participating In The Study? How Do We Find Out The Results?

We sincerely appreciate the time you are giving up to participate in this study and will, therefore, reimburse you for your time and travel expenses. You will be provided with a fun DVD of some of you child’s MRI images as well as a general assessment of his/ her behavioral functioning compared to other children in the same age range.  Once the study is finished, we will send you a report of the overall findings.  As it is a longitudinal study, we will also send you any interim results of study progress and significant findings. We will not routinely provide individual feedback, however.  The purpose of the MRI scan is not to make a clinical diagnosis - the images will not provide the same information as those obtained for clinical purposes.  However, in the unlikely event that anything unusual is noticed, the images will be forwarded to a trained and board certified neuroradiologist and you will be informed.  We will leave the decision of whether to forward this information and images onto your family doctor up to you. Other than passing this information to you promptly, the researchers will not be responsible for any further clinical management in this unlikely event.

When Can I Withdraw From the Study?

You can withdraw from the study at any time without need for justification.  We want to make sure that you and your child and happy and relaxed throughout the session and study.

All information we will obtain from you is strictly confidential. We will store the data of your child’s scans, functional evaluations and interviews, as well as medical history details, anonymously and safely using secure computerized data storage systems at a secure location within the Barus and Holley Building on Brown University campus. Only members of the research team will have access to this anonymised information.

It is up to you to decide whether or not to take part.  If you do decide to take part, you will be given this information sheet and asked to sign a consent form. You will also be asked to sign the MRI addendum sheet on behalf of your child. If you decide to take part, you are still free to withdraw at any time, without need of justification.

If you agree to take part you will also be asked whether you are happy to be contacted about participating in future research studies at the end of this form.  Your participation in this study will not be affected should you choose not to be contacted about other studies.  A decision to withdraw at any time, or a decision to not take part, will not affect the standard of care you or your child receive.  You may withdraw your child’s data from the project at any time until it is transcribed for use in the final report.

If you have any questions regarding this research, please feel free to contact the lead researcher on this project,

    Dr. Sean Deoni, PhD

    Telephone: 401-863-7661.   

    Email: Sean_C_Deoni@brown.edu

If you have any questions with regards to yours, or your child’s rights as a research participant, please feel free to contact the Brown University Research Protections Office.

    Brown University Research Protections Office.

    Telephone: 401-863-3050.