Teens 13 to 17 Years Old with Epilepsy Needed for a Research Study

Why are we doing this research?

Cincinnati Children’s is conducting a research study, sometimes known as a clinical trial or clinical study, to learn more about the areas of the brain normally used for executive functions (thinking skills like planning, organization and memory) and how they may be different in teens that have epilepsy.

These executive functions can affect areas of life such as school performance, social skills and adherence to medication.

Who can participate?

Teens 13 to 17 years old who been diagnosed with epilepsy and have had a seizure within the past year, may be eligible for participation.

Teens who have the following will NOT be able to participate: 

    • A non-removable implant or metal device (like a cochlear implant, pacemaker or braces)
    • A diagnosis of any developmental delay (such as autism) or psychiatric problem (such as bipolar)

 

Conditions

  • Epilepsy

What will happen in the study?

If your teen is eligible, and you decide to participate, he or she will come to Cincinnati Children’s for 1 to 2 study visits. These visits will last 3 to 4 hours total.

The following is a list of some of the tests and procedures that will happen during the study:
  • Review of family’s medical history
  • Review of your teen’s medical history: we will collect information from your teen’s hospital chart (including age at start of epilepsy, seizure type, seizure cause, presence of seizures in the last year, time since diagnosis and any psychological disorders)
  • functional Magnetic Resonance Imaging (fMRI): a test that will look closely at your teen’s brain activity (makes pictures of the brain) while he or she plays some games; looks at pictures, words and numbers; and listen to words and sounds
  • Attention, intelligence, memory and/or certain school skill tests: your teen will finish these tests, which will last about 1 hour
  • Teen questionnaire: your teen will complete 1 questionnaire asking how he or she plans, organizes and remembers things
  • Parent questionnaire: you will answer questions and/or complete measures about your teen’s organization, planning, memory, thinking skills, behavior and emotions
Please Note:
During the fMRI, all metal objects and jewelry will be removed from your teen’s body and clothing. While in the MRI, which takes 45 to 60 minutes, your teen will be able to talk to us through a microphone. If he or she is uncomfortable in the MRI, we will take them out of the MRI.

The attention, intelligence and/or memory tests are not the same as the tests that are given if your teen were having learning problems in school. If a significant problem is found on these tests, your teen’s doctor may ask for there to be additional testing at school or by a specialist in learning difficulties.

Parents interested in having their teen 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/or your teen and will be sure that all of your questions are answered.

What are the good things that can happen from this research?

Your teen may receive a direct medical benefit from participating in this study. He or she will have basic testing of his or her attention and other learning abilities, which can identify school and learning problems that may require additional testing and intervention. These tests are typically not offered all the time and cost a lot of money; however, as they are part of the research study, they are no cost to you. 

The information learned from this study may benefit patients with epilepsy/seizures in the future. We hope this research will help us to see how and where the brain normally works when we are thinking and planning. When we finish the research, we expect that we will know if seizures change the way the brain thinks.

What are the bad things that can happen from this research?

Common risks include anxiety and/or feeling nervous from laying in the MRI.

A detailed list of possible side effects will be provided to those participants, parents or guardians interested in knowing more about this study.

Will you/your child be paid to be in this research study?

Participants will receive up to $60 for their time and effort for this study.

Contact

Contact Us.Angela Moore
513-636-3920
brainimaging@cchmc.org
Cincinnati Children’s Hospital Medical Center
Division of Neurology
3333 Burnet Avenue
Cincinnati, OH 45229-3039

Study Doctor

Contact Us.Avani Modi, PhD
Director, Center for Adherence
Co-Director, New Onset Seizure Clinic
Cincinnati Children’s Hospital Medical Center
Division of Behavioral Medicine and Clinical Psychology

Jennifer Vannest, PhD
Assistant Director, Pediatric Neuroimaging Research Consortium
Cincinnati Children’s Hospital Medical Center
Division of Neurology