Evaluate the initial safety and effectiveness of Microburst VNS stimulation in subjects with refractory epilepsy.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
33
Implantable generator with new stimulation feature under study to determine the safety and effectiveness of device stimulation on different seizure types.
University of Alabama at Birmingham
Birmingham, Alabama, United States
University of Denver Colorado
Denver, Colorado, United States
Mayo Clinic Florida
Jacksonville, Florida, United States
Rush University
Chicago, Illinois, United States
Efficacy Primary Endpoint: Percent change from baseline in seizure frequency
For the primary endpoint, the change in the seizure frequency per month compared to baseline will be evaluated for each subject at follow-up visits month 6 and 12.
Time frame: Up to 12 months study visit
Safety Primary Endpoint: Occurrence of stimulation related Adverse Events
Assess stimulation/device related adverse events at follow-up visits month 6 and 12.
Time frame: Up to 12 months study visit
Change from baseline in seizure frequency per month based on seizure diary provided by the sponsor
Time frame: Up to 12 months study visit
Change from baseline in seizure severity
As measured by the Seizure Severity Questionnaire (SSQ) scale (Cramer, 2002).
Time frame: Up to 12 months study visit
Change from baseline in quality of life
As measured by the QOLIE-31-P for adults 18 years and older (Cramer et al.; 1998) and QOLIE-AD-48 for adolescents 12 to 17 years (Cramer et al.; 1999).
Time frame: Up to 12 months study visit
Change from baseline in antiepileptic drug (AED) load
Estimated as the sum of the prescribed daily dose (PDD)/defined daily dose (DDD) ratios for each AED included in the treatment regimen (Deckers et al., 1997), where DDD (WHO ATC/DDD index) corresponds to the assumed average therapeutic daily dose of a drug used for its main indication.
Time frame: Up to 12 months study visit
Suicidality as measured by the Columbia Suicide Severity Rating Scale (C-SSRS)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Northwestern University
Evanston, Illinois, United States
Weil-Cornell Medical College
Ithaca, New York, United States
Duke University
Durham, North Carolina, United States
University of Utah
Salt Lake City, Utah, United States
Ghent University Hosptial
Ghent, Belgium
Time frame: Up to 12 months study visit
All adverse events
Time frame: Up to 12 months visit