Microburst Vagus Nerve Stimulator (VNS) Therapy Feasibility Study

NCT03446664 | Completed FDA Device

• 1 other identifier: LNN001
• Study Type: interventional
• Target: 33
• Locations: 2 countries
• Sites: 9

Brief Summary

Evaluate the initial safety and effectiveness of Microburst VNS stimulation in subjects with refractory epilepsy.

Conditions

Epilepsies, Partial; Epilepsy, Tonic-Clonic

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  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

  Up to 12 months study visit

• Change from baseline in seizure severity

  Up to 12 months study visit

• Change from baseline in quality of life

  Up to 12 months study visit

• Change from baseline in antiepileptic drug (AED) load

  Up to 12 months study visit

• Suicidality as measured by the Columbia Suicide Severity Rating Scale (C-SSRS)

  Up to 12 months study visit

Study Arms (1)

Microburst Stimulation

EXPERIMENTAL

Microburst stimulation to tolerability and effectiveness

Device: Microburst Stimulation

Interventions

Microburst Stimulation DEVICE

Implantable generator with new stimulation feature under study to determine the safety and effectiveness of device stimulation on different seizure types.

Microburst Stimulation

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).
• (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.
• (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.
• \. 12 years of age or older.
• \. Subject is a male or non-pregnant female adequately protected from conception. Females of childbearing potential must use an acceptable method of birth control.
• \. 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• LivaNova: lead

Study Sites (9)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

University of Denver Colorado

Denver, Colorado, 80204, United States

Location

Mayo Clinic Florida

Jacksonville, Florida, 32224, United States

Location

Rush University

Chicago, Illinois, 60612, United States

Location

Northwestern University

Evanston, Illinois, 60208, United States

Location

Weil-Cornell Medical College

Ithaca, New York, 10065, United States

Location

Duke University

Durham, North Carolina, 27708, United States

Location

University of Utah

Salt Lake City, Utah, 84112, United States

Location

Ghent University Hosptial

Ghent, Belgium

Location

Related Publications (3)

• 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.

  PMID: 38532258 DERIVED

• Drees 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.

  PMID: 38499287 DERIVED

• Verner 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.

  PMID: 37384278 DERIVED

MeSH Terms

Conditions

Epilepsies, Partial; Epilepsy, Tonic-Clonic

Condition Hierarchy (Ancestors)

Epilepsy; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Epilepsy, Generalized

Study Officials

• Selim Benbadis, MD

  University of South Florida Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: February 9, 2018
• First Posted: February 27, 2018
• Study Start: February 27, 2018
• Primary Completion: July 30, 2021
• Study Completion: October 27, 2021
• Last Updated: October 25, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (8); BE (1)