An interventional study of Microburst Stimulation in Epilepsies, Partial and Epilepsy, Tonic-Clonic, sponsored by LivaNova. Completed at 9 sites in 2 countries. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2022-10-25.
Sponsored by LivaNova · Not applicable, Interventional, and Treatment
Among 102 studies in Epilepsies, Partial with a site in United States — 18 open to participants now, 24 under way, 6 of them phase 3. Epilepsies, Partial · United States.
Among the 102 studies in Epilepsies, Partial with a site in United States, this one is the 60th largest by enrollment of the 86 interventional ones that give a count, is one of 3 that started in 2018, is one of 14 with no phase, and was the 69th registered.
243 studies on the registry are indexed under Epilepsies, Partial; 49 are open to participants now.
This study's enrollment of 33 is below the median of 90 across 187 interventional studies indexed under Epilepsies, Partial.
Browse Epilepsies, Partial studies →18 of the 102 studies in Epilepsies, Partial with a site in United States are open now.
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 37 Epilepsies, Partial studies recruiting now, 9 (24%) set no upper age limit and 24 (65%) stop at 75 or younger; 17 take children under 18; 3 take healthy volunteers.
This study: 12 Years and older · all sexes · no healthy volunteers.
The full table on the hub →102 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 6 · Phase 2 28 · Phase 3 34 · Phase 4 9
First in 1992; this study’s year is marked. 3 started in 2018.
Median enrollment 100 across the 86 interventional studies, 100 across the 16 observational. Of the 73 that completed or were terminated, 37 (51%) have results posted.
63 of 102 have an industry lead sponsor. The 10 most frequent:
LivaNova is the lead sponsor of 40 studies on the registry; 2 are open to participants now.
LivaNova has 1 study filed under Epilepsies, Partial — fewer than ten, so there is no comparison to draw.
10 of the studies in Epilepsies, Partial with a site in United States that are under way reach primary completion within a year, 2 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06132893Phase 3Biohaven Therapeutics Ltd.A Study to Determine if BHV-7000 is Effective and Safe in Adults With Refractory Focal Onset Epilepsy | 2026-12 |
| NCT07505004Phase 3Praxis Precision MedicinesRandomized Clinical Trial Evaluating the Efficacy and Safety of Vormatrigine in Adults With Focal Seizures | 2027-01 |
| NCT06443463Biohaven Therapeutics Ltd.Long-term Safety and Tolerability of BHV-7000 | 2026-12 |
| NCT05673915Mayo ClinicStudy of Transcranial Direct Current Stimulation to Treat Epilepsy | 2026-12 |
| NCT05794295University of California, DavisSleep Architecture & Cognition in Focal Epilepsy | 2026-12-01 |
Among the 102 studies in Epilepsies, Partial with a site in United States, from their registry updates:
Evaluate the initial safety and effectiveness of Microburst VNS stimulation in subjects with refractory epilepsy.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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)
Time frame: Up to 12 months study visit
All adverse events
Time frame: Up to 12 months visit
Plan to share: No
No publications or documents are linked to this record.
Ran from Feb 2018 to primary completion in Jul 2021, 41 months.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Oct 2022. You cannot join it, but the record below documents what was studied.
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