Medtronic Deep Brain Stimulation (DBS) Therapy for Epilepsy Post-Approval Study (EPAS)
The purpose of this post-approval study is to further evaluate the long-term safety and effectiveness of Medtronic DBS therapy for epilepsy on seizure reduction in newly implanted participants through 3 years of follow-up.
• Focal (partial) onset seizures (based on International League Against Epilepsy (ILAE) 2017 classification) that may or may not evolve to a bilateral tonic-clonic seizure (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 EEG (inpatient or ambulatory) that captured at least one ictal event
• Anticipated average of 6 or more focal (partial) onset seizures per month during CMM phase, with no more than 30 consecutive seizure-free days during the CMM phase
• Refractory to at least 3 antiepileptic drugs (AEDs) due to lack of effectiveness
• Age 18 or older at the time of enrollment
• Willing and able to complete the diary, with or without the assistance of a caregiver, in a reliable way as assessed by the clinical staff
• Able to use the Patient Programmer with or without the assistance of a caregiver
• Ability of the subject or legal representative to understand and provide signed consent for participating in the study
• Willing and available to attend visits as scheduled and to comply with the study protocol