Medtronic Deep Brain Stimulation (DBS) Therapy for Epilepsy Post-Approval Study (EPAS) (NCT03900468) | Clinical Trial Compass
TerminatedNot Applicable
Medtronic Deep Brain Stimulation (DBS) Therapy for Epilepsy Post-Approval Study (EPAS)
Stopped: Study was terminated early since effectiveness and safety of the DBS Therapy System for Epilepsy was evaluated by using real-world evidence (RWE) gathered from the Medtronic Registry for Epilepsy (MORE).
United States29 participantsStarted 2020-03-05
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* Generalized onset epilepsy type (based on International League Against Epilepsy (ILAE) 2017 classification)
* Seizure frequency is too frequent that subject is unable to provide daily count in order to maintain a reliable seizure diary
* Any episode of convulsive status epilepticus …
What they're measuring
1
Percentage Reduction in Total Seizure Frequency
Timeframe: Pre-implant compared to 36 months post-implant