Trial Search Results

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

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.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

MedtronicNeuro

Stanford Investigator(s):

Intervention(s):

  • Device: Medtronic DBS Therapy for epilepsy
  • Device: Medtronic DBS Therapy for epilepsy

Phase:

Phase 3

Eligibility


Relevant Inclusion and Exclusion Criteria are listed below.

Inclusion Criteria

   - Partial-onset seizures with or without secondary generalization. The final
   determination shall be made by the Investigator based on a clinical description of the
   seizures and previous diagnostic testing that includes, at a minimum, video/clinical
   EEG that captured at least one ictal event.

   - Anticipated average of 6 or more partial-onset seizures (with or without secondary
   generalized seizures) per month during the Baseline Phase, with no more than 30 days
   between seizures during the Baseline Phase.

   - Refractory to antiepileptic drugs (AEDs). Patients will be considered refractory if
   they have failed at least three AEDs due to lack of efficacy.

   - Receiving one to four currently marketed AEDs

   - Be between 18 and 65 years of age at the time of lead implant

Exclusion Criteria:

   - Multilobar (>3 different lobes) anatomic areas of seizure onset

   - Symptomatic generalized epilepsy

   - Previous diagnosis of psychogenic/non-epileptic seizures

   - Presence of implanted electrical stimulation medical device anywhere in the body
   (e.g., cardiac pacemakers, spinal cord stimulator) or any metallic implants in the
   head (e.g., aneurysm clip, cochlear implant). Vagal nerve stimulators are allowed if
   the device has been turned off for at least 30 days prior to the Baseline Week -12
   visit and the patient agrees to have the generator explanted prior to or at the time
   of the Kinetra Neurostimulator implant.

Ages Eligible for Study

18 Years - 65 Years

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Mimi Callanan, NP
Not Recruiting