NCT03446664
Completed
Not Applicable
Microburst VNS Therapy Feasibility Study in Subjects With Refractory Epilepsy
Overview
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- LivaNova
- Enrollment
- 33
- Locations
- 9
- Primary Endpoint
- Safety Primary Endpoint: Occurrence of stimulation related Adverse Events
Overview
Brief Summary
Evaluate the initial safety and effectiveness of Microburst VNS stimulation in subjects with refractory epilepsy.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 12 Years to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
- •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.
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.
Outcomes
Primary Outcomes
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.
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.
Secondary Outcomes
- Change from baseline in seizure frequency per month based on seizure diary provided by the sponsor(Up to 12 months study visit)
- All adverse events(Up to 12 months visit)
- Change from baseline in seizure severity(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)
- Change from baseline in quality of life(Up to 12 months study visit)
Investigators
Study Sites (9)
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