Clinical Trials / Research Studies

Clinical Trials / Research Studies

What will happen in the study?

If your child is eligible and you decide to participate, your child will have These are the tests and procedures that will happen during the research study:

• Language and sound testing
• Magnetic Resonance Imaging (MRI) test: a non-invasive test that takes pictures of the body using a large magnet, radio waves and a computer
• Therapy sessions

You and your child will first be asked to go to the Speech and Hearing Clinic at the University of Cincinnati where your child will take part in some tests about ability with ordinary language. Your child will be asked how he or she understands the meaning of words and sentences and how he or she says words and sounds. Your child may also be asked to listen to words or sentences and to say something about what they hear.

Your child will also participate in 16 therapy visits at the Speech and Hearing Clinic focusing on the “r” sound. The sessions will occur once per week for 16 weeks with the possibility of 2 extra therapy visits at the end, if testing takes longer or there are interruptions to the full sessions, etc.

During the therapy sessions, which will each take about an hour, your child will say some words and sentences while using an ultrasound machine that shows pictures of how the tongue moves when he or she talks. Your child will be asked to practice saying particular words and sounds, and to hold some of the sounds for a long time without moving. Your child may also be asked to listen to some sounds or words and describe what he or she hears.

Your child’s voice will be recorded during the therapy sessions. The person doing the study will save a video of your child’s tongue movements and voice for the study. You will be given a copy of this video if you want. A video copy of the therapy session showing your child’s face may also be made at times; however, the copy will remain confidential among members of the research team.

Also during this time, your child will take 2 MRIs,16 to 18 weeks apart, at Cincinnati Children’s. One MRI will happen at the beginning of the therapy sessions and one will happen at the end.

Each MRI session will take about an hour and a half. The machine is very loud while it is making pictures, but your child will be given hearing protection that should make the noise softer and more comfortable. Your child will be able to hear the people who are doing the study while he or she is in the machine, and your child will be able to talk to them.

While in the MRI, your child will be asked to lie down and do 2 different types of tasks. Staff will review the tasks with your child before the MRI sessions, which will take about 10 minutes.

The first task your child will be asked to do is say particular sounds and to hold the sounds without moving. The MRI will make a picture of your child’s mouth and tongue, and some other parts of the head, while he or she is holding these sounds. It takes a while for each picture to be made and your child may have to stay still for as long as 13 seconds while this happens.

Your child will be asked to move on to the second task and repeat some real words and made-up words. Immediately afterwards, the MRI will make pictures of where your child’s brain seems to be busiest. Again, your child will have to stay as still as possible during this time.

Your child’s voice will be recorded during the MRI. The people doing the study will save the copy of your child’s voice along with the pictures taken in the MRI. They will give you a copy of the pictures if you want, but it might take a day or so before you can get the copy.

The information collected in this study will be made publicly available for teachers, speech therapists and parents to help people who have difficulties with speech. The information may be provided by means of a textbook, a website, or some other type of computer storage, like DVD’s or USB drives.

Parents, guardians or participants interested in having their child participate will be given a consent form that thoroughly explains all of the details of the study. A member of the study staff will review the consent form with you and will be sure that all of your questions are answered.