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

Phase

Condition

Epilepsy

Treatment

N/A

Clinical Study ID

NCT00101933

1604

Ages 18-65
All Genders

Study 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.

Eligibility Criteria

Inclusion

Relevant Inclusion and Exclusion Criteria are listed below. Inclusion Criteria

Partial-onset seizures with or without secondary generalization. The finaldetermination shall be made by the Investigator based on a clinical description of theseizures and previous diagnostic testing that includes, at a minimum, video/clinicalEEG that captured at least one ictal event.
Anticipated average of 6 or more partial-onset seizures (with or without secondarygeneralized seizures) per month during the Baseline Phase, with no more than 30 daysbetween seizures during the Baseline Phase.
Refractory to antiepileptic drugs (AEDs). Patients will be considered refractory ifthey 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

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 thehead (e.g., aneurysm clip, cochlear implant). Vagal nerve stimulators are allowed ifthe device has been turned off for at least 30 days prior to the Baseline Week -12visit and the patient agrees to have the generator explanted prior to or at the timeof the Kinetra Neurostimulator implant.

Study Design

December 01, 2003

October 31, 2017

Study 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.