No abstract

ObjectivesThe Automatic Stimulation Mode (AutoStim) feature of the Model 106 Vagus Nerve Stimulation (VNS) Therapy System stimulates the left vagus nerve on detecting tachycardia. This study evaluates performance, safety of the AutoStim feature during a 3‐5‐day Epilepsy Monitoring Unit (EMU) stay and long‐ term clinical outcomes of the device stimulating in all modes.Materials and MethodsThe E‐37 protocol (NCT01846741) was a prospective, unblinded, U.S. multisite study of the AspireSR® in subjects with drug‐resistant partial onset seizures and history of ictal tachycardia. VNS Normal and Magnet Modes stimulation were present at all times except during the EMU stay. Outpatient visits at 3, 6, and 12 months tracked seizure frequency, severity, quality of life, and adverse events.ResultsTwenty implanted subjects (ages 21–69) experienced 89 seizures in the EMU. 28/38 (73.7%) of complex partial and secondarily generalized seizures exhibited ≥20% increase in heart rate change. 31/89 (34.8%) of seizures were treated by Automatic Stimulation on detection; 19/31 (61.3%) seizures ended during the stimulation with a median time from stimulation onset to seizure end of 35 sec. Mean duty cycle at six‐months increased from 11% to 16%. At 12 months, quality of life and seizure severity scores improved, and responder rate was 50%. Common adverse events were dysphonia (n = 7), convulsion (n = 6), and oropharyngeal pain (n = 3).ConclusionsThe Model 106 performed as intended in the study population, was well tolerated and associated with clinical improvement from baseline. The study design did not allow determination of which factors were responsible for improvements.

Acute sleep deprivation did not affect seizure frequency during inpatient monitoring in our patients with intractable complex partial seizures with secondary generalization.

No abstract

Summary:Purpose: Status epilepticus (SE) is a life-threatening medical condition associated with significant morbidity and mortality that requires urgent medical intervention. Although several agents are available to treat SE, they occasionally fail to abort seizure activity. Topiramate (TPM) was anecdotally reported to be effective in adult patients with refractory SE. In this study, we evaluated the efficacy of TPM administered to children with this condition.Methods: We retrospectively reviewed the pediatric SE database at the University of Michigan Medical Center and identified three children with refractory SE who were treated with TPM. Those children failed to respond to treatment with benzodiazepines, phenytoin, phenobarbital, midazolam, or pentobarbital. Additional treatment with TPM was administered by nasogastric tube. All patients were continuously monitored by 21-channel digital EEG machines, and the diagnosis of SE was made by a board-certified neurophysiologist.Results: The ages of the three children were 4.5 months, 34 months, and 11 years. TPM was initiated at 2 mg/kg/day in two children and at 3 mg/kg/day in the third. The status was terminated in all three children within 24 h of maintenance therapy with TPM at 5-6 mg/kg/day.Conclusions: These results support the potential efficacy of TPM for children with refractory SE. Larger prospective series are needed to confirm those results. Key Words: TopiramateSafety-Status epilepticus-Efficacy-Antiepileptic drugs.Status epilepticus (SE) in childhood is a serious and potentially life-threatening medical condition that requires immediate medical intervention (1). It is estimated that 0.4-0.8% of children will experience an episode of convulsive SE before age 15 years (2). Various treatment protocols have been advocated to treat SE in children including benzodiazepines (BZDs), phenytoin (PHT)/fosphenytoin (FOS), barbiturates, paraldehyde, and general anesthesia (3). Although these agents are usually successful in terminating seizure activity, some seizures remain refractory and require additional intervention. Refractory SE has been defined as seizures lasting >60 min despite treatment with BZDs and an adequate intravenous loading dose of a standard anticonvulsant drug (AED) (4) or the persistence of seizure activity despite appropriate medical and AED therapy (5). Refractory SE in childhood was shown to be associated with a high morbidity and a mortality rate of ≤32% (6).Topiramate (TPM) is a second-generation AED with multiple mechanisms of action including blockade of voltage-sensitive Na + and L-type Ca 2+ channels, enAccepted June 25, 2003. Address correspondence and reprint requests to Dr. A. Beydoun at University of Michigan Health System, 1500 E. Medical Center Drive, UH1B300/0036, Ann Arbor, MI 48109-0036, U.S.A. E-mail: beydoun@umich.edu hancement of γ -aminobutyric acid (GABA) activity at GABA A receptors, inhibition of kainate-evoked currents, and inhibition of certain carbonic anhydrase isozymes (7). It was recently reported to be beneficia...