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

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ClinicalTrials.gov Identifier: NCT03446664
Recruitment Status : Not yet recruiting
First Posted : February 27, 2018
Last Update Posted : February 27, 2018
Information provided by (Responsible Party):

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

Condition or disease Intervention/treatment Phase
Epilepsies, Partial Epilepsy, Tonic-Clonic Device: Microburst Stimulation Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Intervention Model: Single Group Assignment
Intervention 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)
Primary Purpose: Treatment
Official Title: Microburst VNS Therapy Feasibility Study in Subjects With Refractory Epilepsy
Anticipated Study Start Date : February 2018
Estimated Primary Completion Date : April 2021
Estimated Study Completion Date : June 2021

Arm Intervention/treatment
Experimental: Microburst Stimulation
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.

Primary Outcome Measures :
  1. 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.

  2. 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.

Secondary Outcome Measures :
  1. Change from baseline in seizure frequency per month based on seizure diary provided by the sponsor [ Time Frame: Up to 12 months study visit ]
  2. Change from baseline in seizure severity [ Time Frame: Up to 12 months study visit ]
    As measured by the Seizure Severity Questionnaire (SSQ) scale (Cramer, 2002).

  3. Change from baseline in quality of life [ Time Frame: Up to 12 months study visit ]
    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).

  4. Change from baseline in antiepileptic drug (AED) load [ Time Frame: Up to 12 months study visit ]
    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.

  5. Suicidality as measured by the Columbia Suicide Severity Rating Scale (C-SSRS) [ Time Frame: Up to 12 months study visit ]
  6. All adverse events [ Time Frame: Up to 12 months visit ]

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
  13. Any history of psychogenic non-epileptic seizures.
  14. Currently participating in another clinical study without LivaNova written approval.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03446664

Contact: Amy Keith 281-228-7495 Amy.keith@livanova.com
Contact: Jeffrey Way 281-228-7394 Jeffrey.way@livanova.com

Sponsors and Collaborators
Principal Investigator: Selim Benbadis, MD University of South Florida Health

Responsible Party: LivaNova
ClinicalTrials.gov Identifier: NCT03446664     History of Changes
Other Study ID Numbers: LNN001
First Posted: February 27, 2018    Key Record Dates
Last Update Posted: February 27, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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
Pediatric Postmarket Surveillance of a Device Product: No

Additional relevant MeSH terms:
Epilepsies, Partial
Epilepsy, Generalized
Epilepsy, Tonic-Clonic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases