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Microburst Vagus Nerve Stimulator (VNS) Therapy Feasibility Study (Microburst)

Primary Purpose

Epilepsies, Partial, Epilepsy, Tonic-Clonic

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Microburst Stimulation
Sponsored by
LivaNova
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Epilepsies, Partial

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. 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).
  2. Must be on adjunctive antiepileptic medications.
  3. 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:

  1. Currently using, or are expected to use, short-wave diathermy, microwave diathermy, or therapeutic ultrasound diathermy.
  2. A VNS Therapy System implant would (in the investigator's judgment) pose an unacceptable surgical or medical risk for the subject.
  3. A planned procedure that is contraindicated for VNS therapy.
  4. History of implantation of the VNS Therapy System.
  5. Currently receiving treatment from an active implantable medical device.
  6. Presence of contraindications to MRI per the MRI subject screening record.
  7. 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).
  8. History of chronotropic incompetence (commonly seen in subjects with sustained bradycardia [heart rate < 50 bpm]).
  9. Cognitive or psychiatric deficit that in the investigator's judgment would interfere with the subject's ability to accurately complete study assessments.
  10. History of status epilepticus within 1 year of study enrollment.
  11. 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.
  12. Currently being treated with prescribed medication that contains cannabis or cannabis related substance including recreational use.
  13. Any history of psychogenic non-epileptic seizures.
  14. Currently participating in another clinical study without LivaNova written approval.

Sites / Locations

  • University of Alabama at Birmingham
  • University of Denver Colorado
  • Mayo Clinic Florida
  • Rush University
  • Northwestern University
  • Weil-Cornell Medical College
  • Duke University
  • University of Utah
  • Ghent University Hosptial

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Microburst Stimulation

Arm Description

Microburst stimulation to tolerability and effectiveness

Outcomes

Primary Outcome Measures

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.
Safety Primary Endpoint: Occurrence of stimulation related Adverse Events
Assess stimulation/device related adverse events at follow-up visits month 6 and 12.

Secondary Outcome Measures

Change from baseline in seizure frequency per month based on seizure diary provided by the sponsor
Change from baseline in seizure severity
As measured by the Seizure Severity Questionnaire (SSQ) scale (Cramer, 2002).
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).
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.
Suicidality as measured by the Columbia Suicide Severity Rating Scale (C-SSRS)
All adverse events

Full Information

First Posted
February 9, 2018
Last Updated
October 21, 2022
Sponsor
LivaNova
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1. Study Identification

Unique Protocol Identification Number
NCT03446664
Brief Title
Microburst Vagus Nerve Stimulator (VNS) Therapy Feasibility Study
Acronym
Microburst
Official Title
Microburst VNS Therapy Feasibility Study in Subjects With Refractory Epilepsy
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
February 27, 2018 (Actual)
Primary Completion Date
July 30, 2021 (Actual)
Study Completion Date
October 27, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
LivaNova

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsies, Partial, Epilepsy, Tonic-Clonic

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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)
Allocation
N/A
Enrollment
33 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Microburst Stimulation
Arm Type
Experimental
Arm Description
Microburst stimulation to tolerability and effectiveness
Intervention Type
Device
Intervention Name(s)
Microburst Stimulation
Intervention Description
Implantable generator with new stimulation feature under study to determine the safety and effectiveness of device stimulation on different seizure types.
Primary Outcome Measure Information:
Title
Efficacy Primary Endpoint: Percent change from baseline in seizure frequency
Description
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
Title
Safety Primary Endpoint: Occurrence of stimulation related Adverse Events
Description
Assess stimulation/device related adverse events at follow-up visits month 6 and 12.
Time Frame
Up to 12 months study visit
Secondary Outcome Measure Information:
Title
Change from baseline in seizure frequency per month based on seizure diary provided by the sponsor
Time Frame
Up to 12 months study visit
Title
Change from baseline in seizure severity
Description
As measured by the Seizure Severity Questionnaire (SSQ) scale (Cramer, 2002).
Time Frame
Up to 12 months study visit
Title
Change from baseline in quality of life
Description
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
Title
Change from baseline in antiepileptic drug (AED) load
Description
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
Title
Suicidality as measured by the Columbia Suicide Severity Rating Scale (C-SSRS)
Time Frame
Up to 12 months study visit
Title
All adverse events
Time Frame
Up to 12 months visit

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Selim Benbadis, MD
Organizational Affiliation
University of South Florida Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
University of Denver Colorado
City
Denver
State/Province
Colorado
ZIP/Postal Code
80204
Country
United States
Facility Name
Mayo Clinic Florida
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
Facility Name
Rush University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Northwestern University
City
Evanston
State/Province
Illinois
ZIP/Postal Code
60208
Country
United States
Facility Name
Weil-Cornell Medical College
City
Ithaca
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Duke University
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27708
Country
United States
Facility Name
University of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112
Country
United States
Facility Name
Ghent University Hosptial
City
Ghent
Country
Belgium

12. IPD Sharing Statement

Plan to Share IPD
No

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Microburst Vagus Nerve Stimulator (VNS) Therapy Feasibility Study

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