Long-term efficacy and safety of thalamic stimulation for drug-resistant partial epilepsy.
Publication/Presentation Date
3-10-2015
Abstract
OBJECTIVE: To report long-term efficacy and safety results of the SANTE trial investigating deep brain stimulation of the anterior nucleus of the thalamus (ANT) for treatment of localization-related epilepsy.
METHODS: This long-term follow-up is a continuation of a previously reported trial of 5- vs 0-V ANT stimulation. Long-term follow-up began 13 months after device implantation with stimulation parameters adjusted at the investigators' discretion. Seizure frequency was determined using daily seizure diaries.
RESULTS: The median percent seizure reduction from baseline at 1 year was 41%, and 69% at 5 years. The responder rate (≥50% reduction in seizure frequency) at 1 year was 43%, and 68% at 5 years. In the 5 years of follow-up, 16% of subjects were seizure-free for at least 6 months. There were no reported unanticipated adverse device effects or symptomatic intracranial hemorrhages. The Liverpool Seizure Severity Scale and 31-item Quality of Life in Epilepsy measure showed statistically significant improvement over baseline by 1 year and at 5 years (p < 0.001).
CONCLUSION: Long-term follow-up of ANT deep brain stimulation showed sustained efficacy and safety in a treatment-resistant population.
CLASSIFICATION OF EVIDENCE: This long-term follow-up provides Class IV evidence that for patients with drug-resistant partial epilepsy, anterior thalamic stimulation is associated with a 69% reduction in seizure frequency and a 34% serious device-related adverse event rate at 5 years.
Volume
84
Issue
10
First Page
1017
Last Page
1025
ISSN
1526-632X
Published In/Presented At
Salanova, V., Witt, T., Worth, R., Henry, T. R., Gross, R. E., Nazzaro, J. M., Labar, D., Sperling, M. R., Sharan, A., Sandok, E., Handforth, A., Stern, J. M., Chung, S., Henderson, J. M., French, J., Baltuch, G., Rosenfeld, W. E., Garcia, P., Barbaro, N. M., Fountain, N. B., … SANTE Study Group (2015). Long-term efficacy and safety of thalamic stimulation for drug-resistant partial epilepsy. Neurology, 84(10), 1017–1025. https://doi.org/10.1212/WNL.0000000000001334
Disciplines
Medicine and Health Sciences
PubMedID
25663221
Department(s)
Department of Medicine
Document Type
Article