Stress Management Intervention for Living with Epilepsy (SMILE)
The purpose of this research is to test whether a behavioral intervention can reduce the frequency of seizures in patients with epilepsy. The study uses smart phone diaries to collect information about seizures, mood, and stress. Subjects will be taught a behavioral technique, which they will practice daily using the smart phones. Eligible subjects include adults 18 years and above with partial epilepsy, experiencing at least 2 seizures per month, on stable dose of medications.
This study is open for recruitment at the following locations:
1. Montefiore Medical Center, Bronx, NY
Principal Investigator: Sheryl Haut, MD (718-920-4898 / email@example.com)
Study Coordinator: Emily Polak, PhD (718-920-6033 / firstname.lastname@example.org)
2. Universityof Cincinnati, Cincinnati, OH
Principal Investigator: Michael Privitera, MD (513-558-5440 / email@example.com)
Study Coordinator: Adrienne Fleck, RN (513-558-3726 / firstname.lastname@example.org)
Epilepsy Study for Children
Cincinnati Children’s Hospital is recruiting children with epilepsy who are 6-11 years old to participate in a research study exploring sleep difficulties and seizure control. This is a research study to find out whether giving a dietary supplement to children with epilepsy helps to improve micro-arousal’s, sleep quality, and provide better seizure control.
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.
Do participants receive pay, compensation or reimbursement?
Participants will receive $500 for their time and travel, if all procedures and visits are completed.
Contact: Twila Rogers at Cincinnati Children’s Hospital Medical Center( email@example.com or 513-636-0599)
Principal Investigator: Sejal Jain, MD, Neurology, Cincinnati Children’s Hospital Medical Center
Many people and organizations are dedicated to finding new and successful treatments for epilepsy. Through research:
- the latest drug treatments have become available.
- non-drug treatments such as the Vagus Nerve Stimulator and the Ketogenic Diet have become viable options.
- innovative and successful surgical techniques have been deployed.
- recently discovered diagnostic techniques and newly developed equipment have been created.
This research has culminated in treatments and techniques for thousands affected by epilepsy who, previously, had few if any options. Still, there remain many unanswered questions about epilepsy, and thousands of people and their loved ones suffer from the disorder and/or the side effects of treatments.
Epilepsy research is conducted by a wide variety of governmental bodies, private non-profit organizations, medical centers, doctors, professional researchers, pharmaceutical companies, medical device companies, and others. Following is a small list of organizations dedicated to epilepsy research:
Epilepsy Foundation Research Newsletter