Long-term efficacy and safety of thalamic stimulation for drug-resistant partial epilepsy

TLDR

Drug‑resistant partial epilepsy remains difficult to treat, and deep brain stimulation of the anterior nucleus of the thalamus (ANT) has emerged as a potential therapeutic option. This study reports the long‑term efficacy and safety outcomes of the SANTE trial’s ANT deep‑brain stimulation in patients with localization‑related epilepsy. Patients were followed for up to five years after device implantation, with stimulation parameters titrated by investigators and seizure frequency monitored via daily diaries and validated scales. Over five years, ANT stimulation produced a median 69 % seizure‑frequency reduction, a 68 % responder rate, 16 % seizure‑free duration, significant improvements in seizure severity and quality of life, and no unexpected adverse device effects, yielding Class IV evidence of sustained benefit.

Abstract

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.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.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).Long-term follow-up of ANT deep brain stimulation showed sustained efficacy and safety in a treatment-resistant population.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.