DBS for Epilepsy
SANTE TRIAL
ANT DBS for Epilepsy
- First RCT - FDA approval in April 2018
- Sponsored by Medtronic
- 157 patients enrolled, 110 implanted (2003-2007, 17 US centers)
- Age 18-65
- Active 5V, cycling mode) vs. no stimulation during blinding (3 months)
- 40.4% reduction in sz (active) vs. 14.5% reduction (control) (p=0.0017)
- Side effects: paresthesia, memory decline, dizziness, implant site pain
- Complications: infections (10/110)