Epilepsy Research Study Archive
Explore some of our recent studies and achievements.
Quality of Life in Neurological Disorders
Many of the traditional clinical or functional measures of disease status, such as tests of muscle strength or counts of seizure frequency, do not adequately represent the full scope of the impact of chronic neurological disorders and their treatments on individuals. More subjective aspects of patients’ functioning, such as social, psychological and mental well-being, may be more important components of an intervention or disease. Measurement of patient-oriented outcomes is a particular concern in clinical trials, where differences in clinical measurements or imaging results may or may not translate into important benefit to the patients.
Some aspects of health-related quality of life (HRQL) have been incorporated into many recent or current clinical trials in neurology, usually as secondary outcome measures. Many measurement scales have been developed for use in various disease settings; however, some of the existing scales have questionable validity and there is no consensus on what HRQL assessment methods should be used within or across studies or disease areas.
Because of the lack of consensus about the best tools or measurement approaches, it is not possible to compare the relative burden of various neurological conditions to each other or to non-neurological diseases; nor is it possible to compare the relative benefits of one treatment over another based on the same patient-centered outcome. Investigators are reluctant to design trials with the primary objective of comparing quality of life, presumably because HRQL outcomes appear to be too subjective, too hard to define concisely, too complex to administer, and too difficult to interpret. There are not very many condition-targeted quality of life surveys for persons with neurological diseases that are reliable, valid, responsive and brief enough to be feasibly administered in a clinical trials setting. The availability of such a tool for persons with neurological diseases would greatly increase the probability that the research community would incorporate patient-centered measures as primary and secondary outcomes in clinical trials.
Childhood onset epilepsy is often the result of co-morbid conditions such as intellectual disabilities and cerebral palsy. Children with epilepsy often face even more complex psychosocial consequences than individuals who develop the disease as adults. The pediatric epilepsy population has approximately a threefold increased risk of subnormal mental ability and other learning and behavior problems, twice the referral rate for mental health services and a threefold increase in utilization of special education services. Adolescents with epilepsy are also noted to have a higher frequency of behavioral problems than do peers who are healthy or have other chronic health problems.
While it has been established that epilepsy HRQL measures developed for adults are not appropriate for use in the pediatric and adolescent populations, there are several factors that complicate assessment of HRQL in the pediatric and adolescent epilepsy populations. These include development-related change in basal functioning; difficulties associated with proxy-assessment; handicaps related to learning ability, behavioral disorders and motor handicap; and the episodic nature of the disease. Recently, pediatric and adolescent measures have been designed to address, at least in part, the above concerns.
The goal of the study was to enroll 800 patients across 10 sites in the United States and Puerto Rico. The goal for Lurie Children's was to enroll 30 to 50 patients.
The primary investigator the project was David Cella, PhD.
Emotional, Behavioral & Learning Problems in Children with Seizures
Sigita Plioplys, MD, is a child psychiatrist who studies emotional, behavioral and learning problems in children with seizures. She examined the risk factors that influence development of emotional and behavioral problems in children with new-onset seizures early in the course of illness, prior to treatment with antiepileptic medications. She has investigated development and psychiatric characteristics of psychogenic non-epileptic seizures. These behavioral spells look like seizures but are psychological in origin and do not result from abnormal electrical brain activity.
Her findings will significantly improve care of these children, who often are undiagnosed for years, and receive unnecessary and potentially harmful treatment with antiepileptic drugs. She has developed new clinical educational programs for child psychiatry fellows focused on multidisciplinary care model for children with epilepsy.
A Multi-Centered Clinical Open-Labeled Trial on the Safety & Efficacy of KetoCal® Use in Patients with Drug Resistant Epilepsy
The ketogenic diet has been used since the 1920s for treatment of epilepsy. Recently, there has been resurgence in its use to manage refractory epilepsy. The ketogenic diet’s mechanism of action is unknown; however, it is thought that the ketone bodies produced as an end product of beta-oxidation may have an anti-convulsant effect. A study in 1998 concluded that the ketogenic diet was well tolerated and was effective. Of 150 children with difficult-to-control epilepsy, 50% of the children had a more than 50% decrease in their seizures. A systematic review of the medical literature concluded that approximately half of children with refractory epilepsy can have a clinically meaningful improvement after treatment with the ketogenic diet. Further, the ketogenic diet is effective in reducing frequency of seizures. Positive effects on quality of life have also been noted, along with a reduction in use, or complete discontinuation, of anti-epileptic medications.
KetoCal is a complete formula developed to specifically meet the nutritional profile of the ketogenic diet and may be consumed as a sole source of nutrition for children older than age one. KetoCal reduces potential errors in making modular feeds and is easier for parents or caregivers to prepare. A short intervention study was conducted in of a total of 14 children (ages one to 10 years) in which KetoCal was substituted for the previous modular feeds. KetoCal was shown to be effective in maintaining the previous level of ketosis compared to when a subject was taking modular feed. In addition, a series of 10 case reports in children over a minimum eight-week period has shown that KetoCal is effective in attaining and maintaining ketosis.
The goal of the study was to enroll 15 subjects ages one- to 10-years-old that meet eligibility criteria to end up with 10 completers across two United States sites and four European sites, including five from Lurie Children’s. The sites will enroll patients with drug-resistant epilepsy, covering at least 80% of their energy requirements with KetoCal either via a tube or orally.
Lurie Children's enrolled nine patients. Six patients will complete the study. The study is no longer enrolling patients and will end in November 2009, a year from when the last patient was enrolled. The Primary Investigator for the study is Steven Yannicelli PhD, RD. Robyn Blackford, RD, LDN. is the primary investigator at Lurie Children's.