This new research device shows very promising result in predicting seizure.
Why this study?
Seizure prediction would be clinically useful in patients with epilepsy and could improve safety, increase independence, and allow acute treatment. We did a multicenter clinical feasibility study to assess the safety and efficacy of a long-term implanted seizure advisory system designed to predict seizure likelihood and quantify seizures in adults with drug-resistant focal seizures.
Group of Australian investigators presented results from a pilot trial of a long-term implanted device designed to predict and count seizures in adults who have drug-resistant epilepsy.In the May 2, 2013 issue of the journal Lancet Neurology, Doctors Cook and a group of Australian investigators presented results from a pilot trial of a long-term implanted device designed to predict and count seizures in adults who have drug-resistant epilepsy.
How they did?
They enrolled patients at three centers in Melbourne, Australia, between March 24, 2010, and June 21, 2011. Eligible patients had between two and 12 disabling partial-onset seizures per month, a lateralized epileptogenic zone, and no history of psychogenic seizures. After devices were surgically implanted, patients entered a data collection phase, during which an algorithm for identification of periods of high, moderate, and low seizure likelihood was established. If the algorithm met performance criteria (ie,
sensitivity of high-likelihood warnings greater than 65% and performance better than expected through chance prediction of randomly occurring events), patients then entered an advisory phase and received information about seizure likelihood. The primary endpoint was the number of device-related adverse events at 4 months after implantation. Our secondary endpoints were algorithm performance at the end of the data collection phase, clinical effectiveness (measures of anxiety, depression, seizure severity, and quality of life) 4 months after initiation of the advisory phase, and longer-term adverse events. This trial is registered with ClinicalTrials.gov, number NCT01043406.
What were results?
They implanted 15 patients with the advisory system. 11 device-related adverse events were noted within four months of implantation, two of which were serious (device migration, seroma); an additional two serious adverse events occurred during the first year after implantation (device-related infection, device site reaction), but were resolved
without further complication. The device met enabling criteria in 11 patients upon completion of the data collection phase, with high likelihood performance estimate sensitivities ranging from 65% to 100%. Three patients' algorithms did not meet performance criteria and one patient required device removal because of an adverse event before sufficient training data were acquired. We detected no significant changes in clinical effectiveness measures between baseline and 4 months after implantation.
Summary of result
Of 15 patients implanted with the device, the system correctly predicted seizures
■with a high warning 65% of the time, and better than 50% in 11 of the 15 patients.
■Eight of the 11 patients had their seizures accurately predicted between 56% and 100% of the time.
■Three patients did not meet performance criteria; one required device removal because of a side effect before sufficient training data was acquired.
■There were 11 device-related side effects noted within four months of implantation, two of which were serious, (migration of the device and/or seroma). Two other serious events occurred the first year after implantation (infection or device site reaction), but were resolved without further complication.
The investigators concluded that intracranial EEG monitoring is feasible in patients who are outside the hospital with drug-resistant epilepsy. This may serve as the pilot to further assess whether seizure prediction becomes a reality.
Analysis
This study showed that intracranial electroencephalographic monitoring is feasible in ambulatory patients with drug-resistant epilepsy. If these findings are replicated in larger, longer studies, accurate definition of preictal electrical activity might improve understanding of seizure generation and eventually lead to new management strategies.
(Source-Journal Lancet Neurology)
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