|Principal Investigator: Blake Newman|
|Keywords: Epilepsy , Seizure , Vagus Nerve Stimulator , VNS , Intractable Epilepsy , Focal seizures , Generalized seizures , Neurology , Neurosurgery||Department: Neurology|
|IRB Number: 00106153||Co Investigator: John Rolston|
|Specialty: Neurosurgery, Neurology, Neurology|
|Sub Specialties: Epilepsy, Seizures|
|Recruitment Status: Enrolling by invitation|
The primary objective of this study is to evaluate the initial safety and effectiveness of Microburst stimulation in subjects with refractory epilepsy; subjects with primary generalized tonic-clonic seizures (PGTC) and subjects with partial onset seizures including complex partial seizures with or without secondary generalization.
Secondary objective is to compare the following measures from baseline:
Change in seizure frequency as measured by subject’s seizure diary (as reported by the subject) and summary of subject seizure diary (as reported by the investigator site).
- Change in seizure severity as measured by the Seizure Severity Questionnaire; SSQ (as reported by the subject).
- Change in quality of life as measured by Quality of Life Questionnaire; QOLIE-31-P or QOLIE-AD-48 (as reported by the subject).
- Change in AED drug load drug change as well as dose change as measured by concomitant anti-epileptic drug log.
- Suicidality as measured by the Columbia Suicide Severity Rating Scale (C-SSRS) (as reported by the investigator site).
- All adverse events as measured by review of safety reports from VNS implantation visit through follow-up.
Subjects must meet all of the following criteria to be considered for enrollment:
B) For subjects with PGTCs: Have at least a total of ≥ 3 countable seizures during the 3 month baseline period. Note: Each seizure within a cluster may be counted as separate seizures.
Subjects who meet any of the following criteria are not eligible to be enrolled in the study: