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Trial Tests Implanted Device Warning of Epilepsy Seizures

Illustration of brain (NIDA)

(National Institute of Drug Abuse)

Medical researchers at University of Melbourne in Australia and medical device developer NeuroVista in Seattle showed the feasibility of a device to alert epilepsy patients of impending seizures. The results of an early-stage clinical trial were reported online today in the journal Lancet Neurology (paid subscription required).

Epilepsy is the name given to a collection of related disorders, where normal brain activity becomes disturbed causing seizures marked by strange sensations, and emotions. Seizures can be benign or mild, but in some cases may become severe or life-threatening, characterized by convulsions, muscle spasms, and loss of consciousness. The Epilepsy Foundation says the condition affects some 50 million people worldwide, including 3 million in the U.S.

NeuroVista, a nine-year old company, developed a system for alerting epilepsy sufferers to early changes in brain activity, to provide advance warning of a seizure. The NeuroVista device is implanted in the patient’s head between the skull and brain surface, which monitors electroencephalography (EEG) signal.

The Melbourne team, led by Mark Cook who chairs the university hospital’s neurology department, collaborated with NeuroVista colleagues to create a companion device implanted in the chest that transmits the patient’s EEG signals to a handheld monitor. The monitor processes the signals from the chest device, to illuminate a red light if the patient is at a high risk of a seizure, white light for moderate risk, and blue light for low risk.

The clinical trial, funded by NeuroVista and conducted in 2010 and 2011, enrolled 15 patients in Australia with drug-resistant epilepsy, age 20 to 62, who experienced between 2 and 12 seizures a month. For the first month, the researchers collected EEG data from the patients, which enabled the Melbourne team to construct algorithms for seizure prediction customized for the individual patients.

The findings showed the algorithms accurately gave high-risk seizure warnings 65 percent of the time, and had a 50 percent or higher acuracy for 11 of the 15 patients. For 8 of the 11 patients, the system accurately predicted seizures between 56 and 100 percent of the time. The researchers reported 11 adverse reactions to the implants, of which 4 events were considered serious: migration of the device, infection, and associated fluid build-up.

Cook believes the device could provide epilepsy sufferers with better management of their condition, which can lead to a higher quality of life. “The problem is that people with epilepsy are, for the most part, otherwise extremely well,” says Cook. “So their activities are limited entirely by this condition, which might affect only a few minutes of every year of their life, and yet have catastrophic consequences like falls, burns, and drowning.”

Cook aims to continue research with the NeuroVista device in clinical trials with larger numbers of patients.

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