Opportunity for Trials
There were several strengths to this study, including the fact that independent reviewers, blinded to patient characteristics other than age, evaluated each EEG. At enrollment of the infants, parents received education about seizure recognition to improve the accuracy of identifying the time of onset.
Of the nine patients who remained seizure-free, eight showed normal development. The exception was a child who showed early signs of autism. Of the three patients who were excluded from the interim analysis because they were treated with vigabatrin on the basis of EEG abnormalities, only one remained seizure-free, according to Dr. Bebin, who reported that continued follow-up on all 40 patients initially enrolled is planned.
While the study has immediate practical implications for monitoring infants with TSC, it also identifies an opportunity to pursue clinical trials testing disease-modifying antiepileptogenic treatment strategies prior to the onset of epilepsy. The identification of this reliable EEG biomarker is expected to facilitate larger studies of preventive epilepsy treatment strategies.
—Ted Bosworth
