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 |
Contact Information
Lilly Fagatele
Lilly.Fagatele@hsc.utah.edu
801-585-9266
Brief Summary
Primary Objective:
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
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.
Inclusion Criteria
Subjects must meet all of the following criteria to be considered for enrollment:
NOTES:
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.
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Exclusion Criteria
Subjects who meet any of the following criteria are not eligible to be enrolled in the study:
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