Status:
COMPLETED
Microburst Vagus Nerve Stimulator (VNS) Therapy Feasibility Study
Lead Sponsor:
LivaNova
Conditions:
Epilepsies, Partial
Epilepsy, Tonic-Clonic
Eligibility:
All Genders
12+ years
Phase:
NA
Brief Summary
Evaluate the initial safety and effectiveness of Microburst VNS stimulation in subjects with refractory epilepsy.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 27 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 27 2021
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT03446664
Start Date
February 27 2018
End Date
October 27 2021
Last Update
October 25 2022
Active Locations (9)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
2
University of Denver Colorado
Denver, Colorado, United States, 80204
3
Mayo Clinic Florida
Jacksonville, Florida, United States, 32224
4
Rush University
Chicago, Illinois, United States, 60612