Why is this study being done?
The purpose of the ECP is to make the most detailed measurements of brain networks to date in people with epilepsy. The study will employ the most sophisticated magnetic resonance imaging (MRI) technologies available today to map connections between brain regions. We will also employ a technique of recording brain activity called magnetoencephalography (MEG) to measure communication between brain regions at a very fast time scale. To correlate the findings from these tests with symptoms of epilepsy, we will also conduct detailed testing of your mental abilities (such as memory, language, and concentration), and obtain details about the nature and frequency of your seizures.
We hope that by studying a large group of people with epilepsy using sensitive and state-of-the-art brain imaging methods, we will discover, for the first time, how changes in brain networks affect people with this condition. We hope the findings from this study will lead directly to new and powerful clinical tools for diagnosis and individualized management of epilepsy.
All of the study activities, except MEG, will be available at both the Medical College of Wisconsin in Milwaukee and the University of Wisconsin in Madison. MEG recordings for this study will be performed only at the Medical College in Milwaukee.
What will happen if I take part in the study?
Your participation in this study will last up to one year. You have the right, however, to withdraw from the study at any time before completion, with no consequences whatsoever. The first step is a review of your medical records by the study team, which will be provided with your permission by your treating physician.
If you qualify to participate, a study coordinator will schedule you for three visits, each lasting about 4 to 5 hours, with ample periods of rest included. These visits can be spaced as far apart or as close together as you wish. For those traveling from a distance, these three visits can be condensed into two longer visits if you prefer. During the visits, we will provide further detailed information about the study procedures, and your written consent to participate in the study will be obtained. You will then complete a medical history interview, participate in tests of your mental abilities, and participate in two brain imaging sessions using MRI.
Following these initial visits, you will be scheduled for the MEG test. Because MEG scanning is available only in Milwaukee, participants wishing to participate in the MEG test will be asked to visit the Medical College in Milwaukee for this test.
One year after you complete your initial evaluation, we will schedule you for a single visit of about 5 hours to complete a follow-up medical questionnaire, mental abilities tests, and an MRI scan.
What side effects or risks can I expect from the study?
Mental abilities tests: These tests are performed in an ordinary room using a computer and computer mouse. The testing does not involve any risks other than what you would encounter in daily life.
MRI scanning: MRI (magnetic resonance imaging) is a way for us to see inside your body. There is no exposure to x-rays or radioactivity during an MRI scan, and the risk of injury is extremely low. However, MRI is not safe for everyone. For example, it is not safe to have an MRI scan if you have an implanted cardiac pacemaker or defibrillator. Your ability to have an MRI will be determined by your doctor and by our research personnel.
During the MRI, you lie on your back, with comfortable pads under your head and knees, and perform mental tasks designed to elicit specific patterns of brain activity. There are no injections, catheters, or other invasive procedures.
MEG recording: MEG is a method for recording the tiny magnetic fields produced by brain activity. As with MRI, there is no exposure to x-rays or radioactivity during an MEG scan, and there are no injections, catheters, or other invasive procedures. During the test, you will lie on a comfortable table in the MEG machine and perform mental tasks designed to elicit specific patterns of brain activity.
Who is eligible?
If you have been diagnosed with epilepsy by your physician, and your seizures are believed to originate from the temporal lobe of the brain, you may qualify to participate in this study. You may not be eligible to participate if your epilepsy is related to other neurological conditions such as stroke, brain tumors, malformations of the brain or blood vessels, or severe head trauma. You must be at least 18 years old and speak English fluently. You must be able to undergo MRI scanning.
Are there any benefits to taking part in the study?
The findings from this study will not benefit you directly in the near term. We hope that the detailed information gathered by this study in people with epilepsy will provide new information that will lead directly to new clinical tools for diagnosis and individualized management of this condition.
Are there any costs associated with taking part in the study?
There are no costs to being part of this study. Neither you nor your health insurance provider will be charged for any study related activities. You will receive a pass for free parking at the study sites during your visits.
Will I be compensated for participating in the study?
Yes. You will receive $30 per hour for time spent participating in study activities, or approximately $630 for completing the entire study. In addition, travel time will be compensated at a rate of $20 per hour.