Vagus Nerve Stimulation Clinical Outcomes Measured Prospectively in Patients Stimulated

NCT01281293 | Completed

• 2 other identifiers: Epilepsy (E)-103E-103
• Study Type: observational
• Target: 124
• Locations: 5 countries
• Sites: 20

Brief Summary

Vagus Nerve Stimulation (VNS) Therapy has been approved marked for the treatment of epilepsy since 1994. This post-market study is designed to follow the clinical course and outcomes for patients with refractory seizures treated with adjunctive VNS Therapy. Seizure frequency, seizure severity, side effects burden, depressive symptoms, global impressions, and health care utilization will be evaluated. The results of this study will provide data to guide physicians and their patients in the use of VNS Therapy for patients with refractory seizures who have failed initial trials of anti-epileptic drug (AED) therapy. The data being collected is not for the purposes of confirmatory assessment.

Conditions

Epilepsy

Keywords

V-COMPAS; Vagus Nerve Stimulation Clinical Outcomes;

Outcome Measures

Primary Outcomes (1)

• Two-Year Clinical Follow-up

  To follow the clinical course of patients with refractory seizures treated with adjunctive VNS Therapy over a two-year follow-up period.

  27 months

Secondary Outcomes (1)

• Efficacy and Safety

  27 months

Eligibility Criteria

• Age: 7 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will consist of patients with a diagnosis of refractory seizures that are treated with adjunctive VNS Therapy.

You may qualify if:

• Patients enrolled in the study must meet all of the following criteria at Visit 1:
• (Baseline) if Screening Incl/Excl is omitted:
• 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.
• 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.
• Patient and/or caregiver must be able to give accurate seizure counts, health outcomes information, and complete study instruments with minimal assistance.
• 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):
• 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.)
• 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.
• Patient must have no more than 4 weeks between seizures (over 2 months) prior to baseline.

You may not qualify if:

• Patients with any of the following will not be eligible for enrollment:
• Patient currently uses, or is expected to use during the study, short-wave diathermy, microwave diathermy, or therapeutic ultrasound diathermy.
• Patient is expected to require full body magnetic resonance imaging during the clinical study.
• Patient has a progressive neurological condition (e.g. brain tumor etc.).
• 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.
• In the investigator's opinion, the patient has a history of noncompliance for seizure diary completion.
• Patient is currently using an investigational device or pharmacologic medication not approved by either EU or US regulatory authority.
• Patient has had a previous VNS Therapy implant.
• In the investigator's opinion, the patient is suicidal.

Sponsors & Collaborators

• Cyberonics, Inc.: lead

Study Sites (20)

Emory Healthcare

Atlanta, Georgia, 30322, United States

Location

University of Illinois College of Medicine at Peoria

Peoria, Illinois, 61656-1649, United States

Location

University of Louisville Hospital

Louisville, Kentucky, 40202, United States

Location

Cornell University

New York, New York, 10065, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

Covenant Hospital

Lubbock, Texas, 79410, United States

Location

St. Luke's Milwaukee

Milwaukee, Wisconsin, 53215, United States

Location

UZ Gasthuisberg

Leuven, Belgium

Location

Epilepsieklinik Tabor - Ladeburger Straße 15

Berlin, Germany

Location

Albert-Ludwigs-Universität Freiburg

Freiburg im Breisgau, Germany

Location

Universitätsklinikum Schleswig-Holstein Campus Kiel

Kiel, Germany

Location

Sheba Medical Center

Ramat Gan, Israel

Location

Birmingham Children's Hospital

Birmingham, United Kingdom

Location

Foundation Trust Queen Elizabeth Hospital Birmingham

Birmingham, United Kingdom

Location

Southmead Hospital Bristol

Bristol, United Kingdom

Location

Great Ormond Street Hospital for Children NHS Foundation Trust

London, United Kingdom

Location

National Hospital for Neurology & Neurosurgery - UCLH

London, United Kingdom

Location

John Radcliffe Hospital

Oxford, United Kingdom

Location

Salford Royal Hospital

Salford, United Kingdom

Location

Royal Hallamshire Hospital

Sheffield, United Kingdom

Location

MeSH Terms

Conditions

Epilepsy

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Jason Jones

  LivaNova

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 5, 2011
• First Posted: January 21, 2011
• Study Start: January 1, 2011
• Primary Completion: August 16, 2018
• Study Completion: August 16, 2018
• Last Updated: September 23, 2019

Record last verified: 2019-09

Locations

GB (8); US (7); BE (1); DE (3); IL (1)