SANTE - Stimulation of the Anterior Nucleus of the Thalamus for Epilepsy
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.
Medtronic, Inc. is sponsoring an investigational study of the Medtronic DBS Therapy for
 epilepsy, the company's deep brain stimulation (DBS) therapy for patients with refractory
 epilepsy. Epilepsy is a condition that affects 2.3 million Americans, and about one-third of
 these patients are refractory, or continue to experience seizures despite a wide range of
 treatment options.

 The prospective, randomized, double-blind trial uses existing technology to test whether
 bilateral stimulation of the anterior nucleus of the thalamus can safely and effectively
 reduce seizure frequency in patients with epilepsy. It includes enrollment of 157 patients at
 17 sites in the U.S. 110 patients were implanted and monitored for 13 months following
 implant, with long-term follow-up until the device is approved or the study is stopped. 109
 of the 110 implanted subjects were randomized to Active stimulation or Control.

 Patients in the active group, who received neurostimulation, were monitored for a reduction
 in seizure rates compared to the control group, who did not receive neurostimulation during
 the three-month double-blind phase. After the double-blind phase, all patients received
 neurostimulation.

 Candidates for the trial were adults with partial-onset epilepsy for whom at least three
 antiepileptic drugs have proven ineffective. They were to have had an average of six or more
 seizures per month. Candidates continued to receive their epilepsy medications while
 participating in the trial.

 Deep brain stimulation therapy has already received approval in the United States, Europe,
 Canada, and Australia for the treatment of Essential Tremor and Parkinson's disease. Deep
 brain stimulation is not approved in the United States for the treatment of epilepsy.
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.