This trial is active, not recruiting.

Condition epilepsy
Treatments medtronic dbs therapy for epilepsy
Phase phase 3
Sponsor MedtronicNeuro
Start date December 2003
End date June 2008
Trial size 157 participants
Trial identifier NCT00101933, 1604


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Active Stimulation
medtronic dbs therapy for epilepsy
Stimulation On
(Sham Comparator)
No Stimulation
medtronic dbs therapy for epilepsy
Stimulation Off

Primary Outcomes

Primary Analysis: Change in Seizure Rate
time frame: Through the end of the three-month blinded phase
Alternative Primary Analysis: Change in Seizure Rate
time frame: Through the end of the three-month blinded phase

Secondary Outcomes

Adverse Events Experienced With the Medtronic DBS System
time frame: Through Year 2 of the long-term follow-up phase
Incidence of Sudden Unexplained Death in Epilepsy (SUDEP)
time frame: Inclusive of all study follow-up after device implantation (mean follow-up 3.7 years)
Seizure Responder Rate
time frame: Through the end of the three-month blinded phase
Change in Percentage of Days Seizure-free
time frame: Through the end of the three-month blinded phase
Percentage Change in the Maximum Length of Seizure-free Intervals
time frame: Through the end of the three-month blinded phase
Proportion of Treatment Failures
time frame: Through the end of the three-month blinded phase

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

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.

Additional Information

Official title SANTE - Stimulation of the Anterior Nucleus of the Thalamus for Epilepsy
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in February 2014.
Information provided to ClinicalTrials.gov by MedtronicNeuro.