Epilepsies, PartialMicroburstNCT03446664
Microburst Vagus Nerve Stimulator (VNS) Therapy Feasibility Study
A study testing Microburst Stimulation in people with Epilepsies, Partial and Epilepsy, Tonic-Clonic, run by LivaNova at 9 sites in 2 countries.
Trial summary
Evaluate the initial safety and effectiveness of Microburst VNS stimulation in subjects with refractory epilepsy. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Epilepsies, Partial, Epilepsy, Tonic-Clonic
- What is being tested?
- Microburst Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 9 sitesin 2 countries
- Study dates
- 27 Feb 2018to 27 Oct 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 14Show fewer
- 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.
Trial locations and contacts
9 sites in 2 countries.
9 sites in 2 countries
United States8 sites
University of Alabama at Birmingham
Birmingham, Alabama, 35294
Rush University
Chicago, Illinois, 60612
University of Denver Colorado
Denver, Colorado, 80204
Duke University
Durham, North Carolina, 27708
Northwestern University
Evanston, Illinois, 60208
Weil-Cornell Medical College
Ithaca, New York, 10065
Mayo Clinic Florida
Jacksonville, Florida, 32224
University of Utah
Salt Lake City, Utah, 84112
About this study
Official title: Microburst VNS Therapy Feasibility Study in Subjects With Refractory Epilepsy
Evaluate the initial safety and effectiveness of Microburst VNS stimulation in subjects with refractory epilepsy.
- Conditions
- Epilepsies, Partial, Epilepsy, Tonic-Clonic
- Being tested
- Microburst Stimulation
- Medical subject headings
- Epilepsies, Partial, Epilepsy, Tonic-Clonic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Microburst StimulationDevice
Implantable generator with new stimulation feature under study to determine the safety and effectiveness of device stimulation on different seizure types.
| Study group | Role | What they receive |
|---|---|---|
| Microburst Stimulation | Experimental | Microburst stimulation to tolerability and effectiveness Receives: Device: Microburst Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Up to 12 months study visit
Secondary outcomes (6)
Change from baseline in seizure frequency per month based on seizure diary provided by the sponsor
Measured: Up to 12 months study visit
Change from baseline in seizure severity
As measured by the Seizure Severity Questionnaire (SSQ) scale (Cramer, 2002).
Measured: 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).
Measured: 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.
Measured: Up to 12 months study visit
Suicidality as measured by the Columbia Suicide Severity Rating Scale (C-SSRS)
Measured: Up to 12 months study visit
All adverse events
Measured: Up to 12 months visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2018
- Study start27 Feb 2018
- Primary completion30 Jul 2021
- Study completion27 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Epilepsies, PartialStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- LivaNova
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Selim Benbadis, MD, Principal investigator, University of South Florida Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03446664
- Sponsor's protocol ID
- LNN001
- Acronym
- Microburst
- Status last verified
- Oct 2022
- First submitted
- 9 Feb 2018
- Last updated
- 25 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Szaflarski JP, Allendorfer JB, Begnaud J, Ranuzzi G, Shamshiri E, Verner R; Microburst Study Group. Optimized microburst VNS elicits fMRI responses beyond thalamic-specific response from standard VNS. Ann Clin Transl Neurol. 2024 May;11(5):1135-1147. doi: 10.1002/acn3.52029. Epub 2024 Mar 26.
PubMed 38532258Drees C, Afra P, Verner R, Kaye L, Keith A, Jiang M, Szaflarski JP, Nichol K; Microburst Study Group. Feasibility study of microburst VNS therapy in drug-resistant focal and generalized epilepsy. Brain Stimul. 2024 Mar-Apr;17(2):382-391. doi: 10.1016/j.brs.2024.03.010. Epub 2024 Mar 16.
PubMed 38499287Verner R, Szaflarski JP, Allendorfer JB, Vonck K, Giannicola G; Microburst Study Group. Modulation of the thalamus by microburst vagus nerve stimulation: a feasibility study protocol. Front Neurol. 2023 Jun 13;14:1169161. doi: 10.3389/fneur.2023.1169161. eCollection 2023.
PubMed 37384278
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microburst VNS Therapy Feasibility Study in Subjects With Refractory Epilepsy
- ClinicalTrials.gov ID
- NCT03446664
- Acronym / sponsor ID
- Microburst / LNN001
- Conditions
- Epilepsies, Partial, Epilepsy, Tonic-Clonic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- LivaNovaIndustry (pharma, biotech, devices)
- Study start
- 27 Feb 2018 (actual)
- Primary completion
- 30 Jul 2021 (actual)
- Study completion
- 27 Oct 2021 (actual)
- First posted
- 27 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Evaluate the initial safety and effectiveness of Microburst VNS stimulation in subjects with refractory epilepsy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Microburst Stimulation | Experimental | Device: Microburst StimulationMicroburst stimulation to tolerability and effectiveness |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Microburst StimulationImplantable generator with new stimulation feature under study to determine the safety and effectiveness of device stimulation on different seizure types. | Device | Microburst Stimulation |
Primary outcome
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.
6 secondary outcomes
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
Change from baseline in quality of life
Time frame: Up to 12 months study visit
Change from baseline in antiepileptic drug (AED) load
Time frame: Up to 12 months study visit
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2022.
- Derived from this study: PubMed 38532258Szaflarski JP, Allendorfer JB, Begnaud J, Ranuzzi G, Shamshiri E, Verner R; Microburst Study Group. Optimized microburst VNS elicits fMRI responses beyond thalamic-specific response from standard VNS. Ann Clin Transl Neurol. 2024 May;11(5):1135-1147. doi: 10.1002/acn3.52029. Epub 2024 Mar 26.
- Derived from this study: PubMed 38499287Drees C, Afra P, Verner R, Kaye L, Keith A, Jiang M, Szaflarski JP, Nichol K; Microburst Study Group. Feasibility study of microburst VNS therapy in drug-resistant focal and generalized epilepsy. Brain Stimul. 2024 Mar-Apr;17(2):382-391. doi: 10.1016/j.brs.2024.03.010. Epub 2024 Mar 16.
- Derived from this study: PubMed 37384278Verner R, Szaflarski JP, Allendorfer JB, Vonck K, Giannicola G; Microburst Study Group. Modulation of the thalamus by microburst vagus nerve stimulation: a feasibility study protocol. Front Neurol. 2023 Jun 13;14:1169161. doi: 10.3389/fneur.2023.1169161. eCollection 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Selim Benbadis, MD principal investigator
University of South Florida Health
9 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Microburst Stimulation in people with Epilepsies, Partial and Epilepsy, Tonic-Clonic, run by LivaNova at 9 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States, Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy Primary Endpoint: Percent change from baseline in seizure frequency (time frame: Up to 12 months study visit). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03446664, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Oct 2022.