Approximately 2 million people, including 400,000 children, in the United States are being treated for epilepsy, and one-third continue to have seizures despite treatment. In order to address an important caregiver need, RTI International has been developing a prototype mobile seizure alert system to help epilepsy patients and their families cope with seizures.
RTI researchers received a $1.6 million grant from the National Institutes of Health to accelerate the development of this device concept and validation in clinical settings.
"A major concern of people with epilepsy and their family is the possibility that an unwitnessed seizure might cause serious injury, loss of consciousness, or even death," said Barbara Kroner, Ph.D., senior epidemiologist at RTI and co-principal investigator of the project. She is also the mother of a child with uncontrolled seizures.
There are presently no reliable home-based monitoring devices available in the United States to assist caregivers with this task, which can result in significant alterations to the family's life routine and stress level. Parents or siblings of children with nocturnal seizures often find themselves sleeping in the same room or even in the same bed with the child in case a seizure occurs.
RTI's alert device will contain an array of noninvasive physiological sensors that measure heart rate, respiration, and body orientation. The detection of seizures is based on physiological effects due to elevated activity of the autonomic nervous system during seizures. RTI had earlier developed a proof-of-concept seizure detection algorithm and validated it in a clinical study.
"The RTI seizure alert system could have a substantial and measurable impact on the epilepsy community by decreasing the number of seizure-related injuries and deaths, improving quality of life, and increasing independence for both patients and caregivers," Kroner said. "Perhaps the most significant benefit of our device is the potential to decrease the incidence of sudden unexplained death in epilepsy (SUDEP), which is most often an unwitnessed nocturnal event related to a tonic-clonic seizure. In these cases, our monitoring device, which includes cardiac and respiratory sensors, could be life saving."
The new grant from the NIH will enable the transition of the proof-of-concept demonstration into a fully functional prototype device. RTI will work with the Division of Epilepsy, Neurophysiology, and Critical Care Neurology at Children's National Medical Center to collect additional data from children admitted to the epilepsy monitoring unit, test the prototype device and identify caregivers that will test the prototype in the home setting.
"This technology is enabled by RTI's ability to combine hardware solutions with proprietary algorithms to enable non-invasive monitoring of neurological conditions," said Kristin Gilchrist, Ph.D., a research engineer and co-principal investigator of the project. "We have a unique ability to solve this complex and important problem."