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Non-Invasive Computerized System for Automatically Initiating Vagus Nerve Stimulation Following Patient-Specific Detection of Seizures or epileptiform discharges

OBJECTIVE
To demonstrate the feasibility of using a computerized system to detect the onset of a seizure and, in response, initiate Vagus nerve stimulation (VNS) in patients with medically refractory epilepsy.


METHODS
We designed and built a non-invasive, computerized system that automatically initiates VNS following the real-time detection of a pre-identified seizure or epileptiform discharge. The system detects these events through patient-specific analysis of the scalp electroencephalogram (EEG) and electrocardiogram (ECG) signals.


RESULTS
We evaluated the performance of the system on 5 patients (A-E). For patients A and B the computerized system initiated VNS in response to seizures; for patients C and D the system initiated VNS in response to epileptiform discharges; and for patient E neither seizures nor epileptiform discharges were observed during the evaluation period. During the 81 hour clinical test of the system on patient A, the computerized system detected 5/5 seizures and initiated VNS within 5 seconds of the appearance of ictal discharges in the EEG; VNS did not seem to alter the electrographic or behavioral characteristics of the seizures in this case. During the same testing session the computerized system initiated false stimulations at the rate of 1 false stimulus every 2.5 hours while the subject was at rest and not ambulating. During the 26 hour clinical test of the system on patient B, the computerized system detected 1/1 seizures and initiated VNS within 16 seconds of the appearance of ictal discharges; VNS did not alter the electrographic duration of the seizure but decreased anxiety and increased awareness during the post-seizure recovery phase. During the same testing session the computerized system did not declare any false detections.


SIGNIFICANCE
Initiating Vagus nerve stimulation soon after the onset of a seizure may abort or ameliorate seizure symptoms in some patients; unfortunately, a significant number of patients cannot initiate VNS by themselves following the start of a seizure. A system that automatically couples automated detection of seizure onset to initiation of VNS may be helpful for seizure treatment.