Vagus Nerve Stimulation Clinical Outcomes Measured Prospectively in Patients Stimulated
NCT ID: NCT01281293
Last Updated: 2019-09-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
124 participants
OBSERVATIONAL
2011-01-31
2018-08-16
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
(Baseline) if Screening Incl/Excl is omitted:
1. Patients must agree to be treated with VNS Therapy. The decision to treat with VNS Therapy must have been made independent of and prior to participation in the study.
2. Patients participating at Sites not located in the US must follow the "Non-US" labeling and be at least 7 years or older and whose epileptic disorder is dominated by partial seizures (with or without secondary generalization) or generalized seizures that are refractory to antiepileptic medications; patients participating at Sites located in the United States must be 12 years or older and have partial onset seizures or must follow the indication for use statement (for VNS Therapy) in the country of origin.
3. Patient and/or caregiver must be able to give accurate seizure counts, health outcomes information, and complete study instruments with minimal assistance.
4. Patient or legal guardian understands study procedures and voluntarily signs an informed consent and in the United States a Health Insurance Portability and Accountability Act (HIPAA) authorization in accordance with institutional policies. In the event that the patient is under the age of 18 the patient will also be required to sign an assent affirming their agreement to participate in research according to local IRB requirements. Similar authorization is required per EC requirements, or equivalent authority.
Additional Continuation Criteria to be evaluated at Visit 2 (Baseline):
5. Patient must be taking at least 1 anti-epileptic drug treatment and stable on said medications for at least 8 weeks (56 days) prior to baseline. (Rescue medication may be allowed on a case-by case basis with Cyberonics approval.)
6. Patient must have a minimum frequency of 3 seizures (excluding absence seizures, simple partial seizures and myoclonic jerks) per month (average over 2 months) prior to baseline; maximum frequency is 20 seizures per day.
7. Patient must have no more than 4 weeks between seizures (over 2 months) prior to baseline.
Exclusion Criteria
1. Patient currently uses, or is expected to use during the study, short-wave diathermy, microwave diathermy, or therapeutic ultrasound diathermy.
2. Patient is expected to require full body magnetic resonance imaging during the clinical study.
3. Patient has a progressive neurological condition (e.g. brain tumor etc.).
4. In the investigator's opinion, the inability of the patient, legal guardian or reluctance of the child to comply with the frequency of clinic visits during the treatment phase.
5. In the investigator's opinion, the patient has a history of noncompliance for seizure diary completion.
6. Patient is currently using an investigational device or pharmacologic medication not approved by either EU or US regulatory authority.
7. Patient has had a previous VNS Therapy implant.
8. In the investigator's opinion, the patient is suicidal.
7 Years
ALL
No
Sponsors
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Cyberonics, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Jason Jones
Role: STUDY_DIRECTOR
LivaNova
Locations
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Emory Healthcare
Atlanta, Georgia, United States
University of Illinois College of Medicine at Peoria
Peoria, Illinois, United States
University of Louisville Hospital
Louisville, Kentucky, United States
Cornell University
New York, New York, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Covenant Hospital
Lubbock, Texas, United States
St. Luke's Milwaukee
Milwaukee, Wisconsin, United States
UZ Gasthuisberg
Leuven, , Belgium
Epilepsieklinik Tabor - Ladeburger Straße 15
Berlin, , Germany
Albert-Ludwigs-Universität Freiburg
Freiburg im Breisgau, , Germany
Universitätsklinikum Schleswig-Holstein Campus Kiel
Kiel, , Germany
Sheba Medical Center
Ramat Gan, , Israel
Birmingham Children's Hospital
Birmingham, , United Kingdom
Foundation Trust Queen Elizabeth Hospital Birmingham
Birmingham, , United Kingdom
Southmead Hospital Bristol
Bristol, , United Kingdom
Great Ormond Street Hospital for Children NHS Foundation Trust
London, , United Kingdom
National Hospital for Neurology & Neurosurgery - UCLH
London, , United Kingdom
John Radcliffe Hospital
Oxford, , United Kingdom
Salford Royal Hospital
Salford, , United Kingdom
Royal Hallamshire Hospital
Sheffield, , United Kingdom
Countries
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Other Identifiers
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E-103
Identifier Type: OTHER
Identifier Source: secondary_id
Epilepsy (E)-103
Identifier Type: -
Identifier Source: org_study_id
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