CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 157 enrolled
Drug / intervention
Medtronic DBS Therapy for epilepsy +1 moredevice
Likely dose
Medtronic DBS Therapy for epilepsy with anterior nucleus of thalamus stimulation (specific dose parameters not specified in available text)AI-extracted
Key inclusion· 5
  • ✓Partial-onset seizures with or without secondary generalization, confirmed by video/clinical EEG capturing ≥1 ictal event
  • ✓Average of ≥6 partial-onset seizures (±secondary generalized) per month during baseline, with no >30 days between seizures
  • ✓Refractory to antiepileptic drugs: failed ≥3 AEDs due to lack of efficacy
  • ✓Currently on 1–4 marketed AEDs
Key exclusion· 4
  • ✕Seizure onset in >3 different lobar anatomic areas (multilobar)
  • ✕Symptomatic generalized epilepsy
  • ✕Prior diagnosis of psychogenic/non-epileptic seizures
  • ✕Implanted electrical stimulation devices (e.g., pacemaker, spinal cord stimulator) or metallic implants in head (e.g., aneurysm clip, cochlear implant). VNS allowed if off ≥30 days and generator explanted prior to/at DBS implant.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00101933
NCT00101933Phase 3Completed
CompareCT.gov

SANTE - Stimulation of the Anterior Nucleus of the Thalamus for Epilepsy

MedtronicNeuro·interventional·Posted Jan 19, 2005·Updated Mar 22, 2018

In Brief

A Phase 3 clinical trial evaluating Medtronic DBS Therapy for epilepsy for Epilepsy. Completed, enrolled 157 participants.

Detailed Summary

The purpose of this research is to study the safety and effectiveness of bilateral stimulation of the anterior nucleus of the thalamus as adjunctive therapy for reducing the frequency of seizures in adults diagnosed with epilepsy characterized by partial-onset seizures, with or without secondary generalization, that are refractory to antiepileptic medications.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsEpilepsy
Countries--
Collaborators--

Timeline

Phase 3CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 19, 2005
Enrollment StartDec 1, 2003
Primary CompletionJun 1, 2008
Study CompletionOct 1, 2017
TodayJul 2, 2026
Enrollment to primary: 4.5 yearsPosted 21.5 years ago

Interventions

Medtronic DBS Therapy for epilepsydevice

Stimulation On

Medtronic DBS Therapy for epilepsydevice

Stimulation Off