December 09, 2009
Allegheny General Hospital (AGH) is the only
site in the country testing a potentially groundbreaking seizure-detection
system.
Funded by a grant from the National Institutes
of Health’s National Institute of Neurological Disease and Stroke, the initial
trial of Optima Neuroscience’s seizure-detection and alert system will include
15 patients in AGH’s Comprehensive Epilepsy Program. The system is
designed to be used at the bedside to help health professionals determine when
seizure activity is occurring.
The ability to confirm seizures could be
especially beneficial in treating patients in intensive care units (ICUs), said
Kevin M. Kelly, MD, PhD, Director, Allegheny General Hospital Center for Neuroscience Research.
Knowing that seizure activity has occurred could prompt physicians to order
medications, imaging tests to check for bleeding on the brain, or other
measures that may not be prescribed without evidence of seizures.
“Some seizures don’t manifest as convulsions—a patient could be lying in bed
and have an electrical brain seizure with no physical manifestation,” said Dr.
Kelly. “This system could serve a great adjunctive role to what you are not
able to observe at the bedside.”
In October, Optima Neuroscience received
clearance from the U.S. Food and Drug Administration to market its IdentEvent™
software to physicians. Allegheny General was involved in testing of the
original software, which uses an algorithm to aid doctors in reviewing
electroencephalography (EEG) results.
The software identifies areas of interest for
physicians, enabling doctors to quickly navigate through a lengthy recording of
brain activity and determine if there has been a surge in electrical activity,
or a seizure.
Initial testing showed that IdentEvent™ was
sensitive enough to accurately detect seizures while eliminating many “false
positives.” In lengthy EEG recordings, such as those used in the diagnosis or
development of treatment plans for epilepsy, muscle
movements such as chewing and even eye blinking can be reflected as suspicious
brain activity.
Neurologists with special training in
interpreting EEGs spend significant time with the technically challenging task
of filtering out these distractions and pinpointing true seizure activity.
“We’re taking that same core technology and
putting it into a monitor that lets bedside hospital staff without extensive
training in reading EEGs know immediately when there is a critical change in
brain function,” said Ryan Kern, MD, President, Optima Neuroscience.
As pulse oximeters revolutionized the
monitoring of lung function, Optima’s products aim to equip non-specialist care
providers in hospital ICUs and Emergency Departments to rapidly and accurately
obtain critical information about the status of the brain.
“Research suggests that as many as 10 to 20
percent of ICU patients have some degree of seizures and we hope to broaden the
utility of EEG by helping to automate the analysis process,” Dr. Kern said.
A broader, multi-center clinical trial of
Optima’s seizure monitoring and alert system is scheduled for next year and
Optima Neuroscience hopes to bring the product to market in 18 months.
Established in 1987, AGH’s Comprehensive
Epilepsy Program is a member of the National Association of Epilepsy Centers
and designated a Level 4 Epilepsy Center. With this unique resource, Allegheny
General has become one of the largest regional and international referral
centers for epilepsy services.