Long-term efficacy and safety of thalamic stimulation for drug-resistant partial epilepsy
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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.
GLOSSARY
- ANT=
- anterior nucleus of the thalamus;
- CI=
- confidence interval;
- DBS=
- deep brain stimulation;
- LSSS=
- Liverpool Seizure Severity Scale;
- QOLIE-31=
- 31-item Quality of Life in Epilepsy;
- SAE=
- serious adverse event;
- SANTE=
- Stimulation of the Anterior Nucleus of the Thalamus for Epilepsy;
- SUDEP=
- sudden unexpected death in epilepsy;
- VNS=
- vagus nerve stimulation
Footnotes
SANTE Study Group coinvestigators and contributors are listed on the Neurology® Web site at Neurology.org.
Go to Neurology.org for full disclosures. Funding information and disclosures deemed relevant by the authors, if any, are provided at the end of the article.
Supplemental data at Neurology.org
- Received April 12, 2014.
- Accepted in final form November 13, 2014.
- © 2015 American Academy of Neurology
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