Microburst Vagus Nerve Stimulator (VNS) Therapy Feasibility Study (Microburst)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03446664 |
Recruitment Status :
Active, not recruiting
First Posted : February 27, 2018
Last Update Posted : December 16, 2020
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Condition or disease | Intervention/treatment | Phase |
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Epilepsies, Partial Epilepsy, Tonic-Clonic | Device: Microburst Stimulation | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 40 participants |
Allocation: | N/A |
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) |
Primary Purpose: | Treatment |
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 |

Arm | Intervention/treatment |
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Experimental: Microburst Stimulation
Microburst stimulation to tolerability and effectiveness
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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 ]

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Ages Eligible for Study: | 12 Years and older (Child, Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Clinical diagnosis of medically refractory epilepsy with primary generalized tonic-clonic seizures (limited to 20 subjects) or partial onset seizures including complex partial seizures with or without secondary generalization (limited to 20 subjects).
- Must be on adjunctive antiepileptic medications.
- Willing and capable to undergo multiple evaluations with functional magnetic resonance imaging (fMRI), electroencephalogram (EEG) and electrocardiogram (ECG).
4(A) For subjects with partial onset seizures: An average of ≥ 3 countable seizures per month based on seizure diary during the 3 month baseline period and no seizure-free interval greater than 30 days during those 3 months.
4(B) For subjects with PGTCs: Have at least ≥ 3 countable seizures during the 3 month baseline period. Note: Each seizure within a cluster may be counted as separate seizures.
5. 12 years of age or older.
6. Subject is a male or non-pregnant female adequately protected from conception. Females of childbearing potential must use an acceptable method of birth control.
7. Provide written informed consent-assent/Health Insurance Portability and Accountability Act (HIPAA) authorization and self-reported measures with minimal assistance as determined by the investigator.
Exclusion Criteria:
- Currently using, or are expected to use, short-wave diathermy, microwave diathermy, or therapeutic ultrasound diathermy.
- A VNS Therapy System implant would (in the investigator's judgment) pose an unacceptable surgical or medical risk for the subject.
- A planned procedure that is contraindicated for VNS therapy.
- History of implantation of the VNS Therapy System.
- Currently receiving treatment from an active implantable medical device.
- Presence of contraindications to MRI per the MRI subject screening record.
- Known clinically meaningful cardiovascular arrhythmias currently being managed by devices or treatments that interfere with normal intrinsic heart rate responses (e.g., pacemaker dependency, implantable defibrillator, beta adrenergic blocker medications).
- History of chronotropic incompetence (commonly seen in subjects with sustained bradycardia [heart rate < 50 bpm]).
- Cognitive or psychiatric deficit that in the investigator's judgment would interfere with the subject's ability to accurately complete study assessments.
- History of status epilepticus within 1 year of study enrollment.
- Dependent on alcohol or narcotic drugs as defined by DSM IV-TR within the past 2 years, based on history. Tests for drug or alcohol use will not be administered.
- Currently being treated with prescribed medication that contains cannabis or cannabis related substance including recreational use.
- Any history of psychogenic non-epileptic seizures.
- Currently participating in another clinical study without LivaNova written approval.

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 | |
Rush University | |
Chicago, Illinois, United States, 60612 | |
Northwestern University | |
Evanston, Illinois, United States, 60208 | |
United States, New York | |
Weil-Cornell Medical College | |
Ithaca, New York, United States, 10065 | |
United States, North Carolina | |
Duke University | |
Durham, North Carolina, United States, 27708 | |
United States, Utah | |
University of Utah | |
Salt Lake City, Utah, United States, 84112 | |
Belgium | |
Ghent University Hosptial | |
Ghent, Belgium |
Principal Investigator: | Selim Benbadis, MD | University of South Florida Health |
Responsible Party: | LivaNova |
ClinicalTrials.gov Identifier: | NCT03446664 |
Other Study ID Numbers: |
LNN001 |
First Posted: | February 27, 2018 Key Record Dates |
Last Update Posted: | December 16, 2020 |
Last Verified: | December 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | Yes |
Device Product Not Approved or Cleared by U.S. FDA: | Yes |
Epilepsy Epilepsies, Partial Epilepsy, Tonic-Clonic Epilepsy, Generalized |
Brain Diseases Central Nervous System Diseases Nervous System Diseases |