Microburst Vagus Nerve Stimulator (VNS) Therapy Feasibility Study (Microburst)
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|ClinicalTrials.gov Identifier: NCT03446664|
Recruitment Status : Active, not recruiting
First Posted : February 27, 2018
Last Update Posted : December 16, 2020
|Condition or disease||Intervention/treatment||Phase|
|Epilepsies, Partial Epilepsy, Tonic-Clonic||Device: Microburst Stimulation||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Two cohorts of subjects with refractory epilepsy; (1) subjects with primary generalized tonic-clonic seizures and (2) subjects with partial onset seizures including complex partial seizures with or without secondary generalization.|
|Masking:||None (Open Label)|
|Official Title:||Microburst VNS Therapy Feasibility Study in Subjects With Refractory Epilepsy|
|Actual Study Start Date :||February 27, 2018|
|Estimated Primary Completion Date :||September 2021|
|Estimated Study Completion Date :||December 2021|
Experimental: Microburst Stimulation
Microburst stimulation to tolerability and effectiveness
Device: Microburst Stimulation
Implantable generator with new stimulation feature under study to determine the safety and effectiveness of device stimulation on different seizure types.
- Efficacy Primary Endpoint: Percent change from baseline in seizure frequency [ Time Frame: Up to 12 months study visit ]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.
- Safety Primary Endpoint: Occurrence of stimulation related Adverse Events [ Time Frame: Up to 12 months study visit ]Assess stimulation/device related adverse events at follow-up visits month 6 and 12.
- 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 [ Time Frame: Up to 12 months study visit ]As measured by the Seizure Severity Questionnaire (SSQ) scale (Cramer, 2002).
- Change from baseline in quality of life [ Time Frame: Up to 12 months study visit ]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).
- Change from baseline in antiepileptic drug (AED) load [ Time Frame: Up to 12 months study visit ]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.
- Suicidality as measured by the Columbia Suicide Severity Rating Scale (C-SSRS) [ Time Frame: Up to 12 months study visit ]
- All adverse events [ Time Frame: Up to 12 months visit ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03446664
|United States, Alabama|
|University of Alabama at Birmingham|
|Birmingham, Alabama, United States, 35294|
|United States, Colorado|
|University of Denver Colorado|
|Denver, Colorado, United States, 80204|
|United States, Florida|
|Mayo Clinic Florida|
|Jacksonville, Florida, United States, 32224|
|United States, Illinois|
|Chicago, Illinois, United States, 60612|
|Evanston, Illinois, United States, 60208|
|United States, New York|
|Weil-Cornell Medical College|
|Ithaca, New York, United States, 10065|
|United States, North Carolina|
|Durham, North Carolina, United States, 27708|
|United States, Utah|
|University of Utah|
|Salt Lake City, Utah, United States, 84112|
|Ghent University Hosptial|
|Principal Investigator:||Selim Benbadis, MD||University of South Florida Health|