DBS for Epilepsy

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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)
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