SANTE (DBS for Refractory Focal)
(2010)Objective
To assess the efficacy and safety of deep brain stimulation (DBS) of the anterior thalamic nucleus in patients with medically refractory focal epilepsy.
Study Summary
• Stimulation of the Anterior Nucleus of the Thalamus for Epilepsy Trial: Deep brain stimulation of the anterior thalamus significantly reduced seizure frequency in drug-resistant epilepsy.
Intervention
Double-blind, randomized controlled trial evaluating DBS targeting the anterior nucleus of the thalamus. After 3 months, all patients received open-label stimulation.
Inclusion Criteria
Adults aged 18–65 with ≥6 partial-onset seizures per month despite treatment with ≥3 antiepileptic drugs.
Study Design
Arms: DBS Stimulation vs. No Stimulation (Control)
Patients per Arm: DBS: 54, Control: 55
Outcome
• Median seizure frequency reduction at 3 months: 40.4% with stimulation vs 14.5% in control (p=0.002)
• At 2 years, median seizure reduction was 56%
• 54% of patients had ≥50% seizure reduction at 2 years
• Common adverse effects: implant site infection, depression, memory problems
• Overall treatment was well tolerated and sustained seizure reduction observed over time
• At 2 years, median seizure reduction was 56%
• 54% of patients had ≥50% seizure reduction at 2 years
• Common adverse effects: implant site infection, depression, memory problems
• Overall treatment was well tolerated and sustained seizure reduction observed over time