North Shore-LIJ Enrolling Patients in Epilepsy Research Study
May 20, 2013
MANHASSET, NY – Most women with epilepsy have normal pregnancies, but appear to be at increased risk for complications such as seizures, depression and cesarean sections. In addition, adverse outcomes such as thinking and behavioral problems sometimes occur in their children.
To establish the risk factors associated with women and epilepsy, doctors at the Comprehensive Epilepsy Care Center at North Shore-LIJ’s Cushing Neuroscience Institute (CNI), have begun enrolling volunteers to participate in a multi-centered research study sponsored by the National Institutes of Health (NIH).
"We are thrilled to be part of this important study that will advance the care for women with epilepsy and their children,” said Cynthia L. Harden, MD, principal investigator of the study at North Shore-LIJ and director of North Shore-LIJ’s Comprehensive Epilepsy Care Center. “The participants will not only receive specialized care during their pregnancies, they will also be contributing to improved outcomes for women with epilepsy and their children in the future.”
There are three groups of participants needed for the research study: mothers with epilepsy; mothers without epilepsy; and non-pregnant women with epilepsy. Locally, the research study will be conducted at North Shore-LIJ’s Comprehensive Epilepsy Care Center, located at 611 Northern Boulevard in Great Neck, NY. Volunteers can participate at no cost and will be compensated for their time.
Study volunteers who are mothers with epilepsy or without epilepsy, should be at or under week 20 of pregnancy, must speak English as first language, and must not be active drug or alcohol abusers or have a serious illness such as cancer. The medical care and treatment will not be altered in any way and participation in this study will not require the participant to change her obstetrician, neurologist, primary care physician or pediatrician. There will be no medications or other types of treatment administered as part of this study. Participation will require 11 visits and nine telephone contacts. The first three visits will be scheduled during the pregnancy and the remaining visits will be after the baby is born. Visits will be scheduled every three months, until 45 months after the birth of the baby, and participants who breast feed will be asked to bring in their newborns when they are six weeks old. Additionally, the child’s father and a close relative will be asked to come in for a one-time visit. Volunteer participants will be required to record seizures and anti-seizure medications daily.
For study volunteers who are non-pregnant women with epilepsy, participation will require a total of seven visits scheduled three months apart. Participants will be asked about their medical, mental and seizure history. Participants will be asked about any medications that are being taken to control seizures. A physical, neurological exam and vital signs will be performed.
All volunteer participants in the study will be provided with an iPod Touch or paper forms to enter information in a private, web-based program designed for this study. Participants will also be given a questionnaire to answer questions about sleep, stress and mood levels.
For more information about the study or to see if you are eligible, call CNI’s Comprehensive Epilepsy Care Center at (516) 325-7060 or go to neurocni.com.
Media Contacts:Michelle Pipia-Stiles, Director, Communications