Epilepsy Study for Children

What is the purpose of this study?

This is a research study to find out whether giving a dietary supplement to children with epilepsy helps to improve these micro-arousals, sleep quality, and provide better seizure control.

Who can participate?

Children 6 to 11 years old who have seizures may be eligible to participate.

Ages

  • From 6 To 11  years old

Conditions

  • Disabilities: Physical
  • Epilepsy
  • Neurology

What is involved?

We will identify if your child is at risk for disturbed sleep by questionnaires. We will do a sleep study on your child. Then, your child will be asked to take either a sugar pill or the dietary supplement. We will repeat a sleep study. Then your child will take the dietary supplement if they were on the sugar pill before and vice versa. We will repeat the sleep study.

At the end of the study, we will be able to identify if your child has these micro-arousals, based on the sleep study, and if the dietary supplement works for your child. If it works, he/she may continue to take it.

We will also measure your child’s behavior and attention and let you know if there is improvement with the supplement.

We will ask you to keep a seizure diary, and we can identify if the supplement made any improvement in your child’s seizures.

This study will last approximately 13 weeks and include 4 study visits.

What are the benefits?

It is possible that the study medication may improve your child’s sleep and seizure control. However, there may be no direct benefit from being in this study. If there are any sleep disorders identified during the study, such as sleep apnea, the study doctor will discuss the results with you and refer your child for further evaluation.
The information learned from this study may benefit other children with epilepsy in the future.

Will I get all the facts about the study?

Parents interested in having their child participate will be given a consent form that thoroughly explains all of the details of the study. The form covers all of the procedures, the risks, the benefits, the reimbursement, who to contact with questions or concerns and more. A member of the study staff will review the consent form with you and will be sure that all of your questions are answered. Study procedures will not begin until a parent/guardian has signed the form.

What are the risks and discomforts of the study?

Although the active study medication occurs naturally in the body and is available as an over-the-counter supplement, some studies have reported side effects such as drowsiness, headache, and nausea. These will be explained in detail.  

Do participants receive pay, compensation or reimbursement?

Participants will receive $500 for their time and travel, if all procedures and visits are completed.

Who should I contact for more information?

Twila Rogers
Cincinnati Children’s Hospital Medical Center
twila.rogers@cchmc.org
513-636-0599

Principal Investigator

Sejal Jain, MD
Neurology
Cincinnati Children’s Hospital Medical Center  

Date

Ongoing