Status:
COMPLETED
SANTE - Stimulation of the Anterior Nucleus of the Thalamus for Epilepsy
Lead Sponsor:
MedtronicNeuro
Conditions:
Epilepsy
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief 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 a...
Detailed 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 ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
December 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2017
Estimated Enrollment :
157 Patients enrolled
Trial Details
Trial ID
NCT00101933
Start Date
December 1 2003
End Date
October 1 2017
Last Update
March 22 2018
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