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Vagus Nerve Stimulation Clinical Outcomes Measured Prospectively in Patients Stimulated (V-COMPAS)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Cyberonics, Inc.
ClinicalTrials.gov Identifier:
NCT01281293
First received: January 5, 2011
Last updated: February 10, 2017
Last verified: February 2017
  Purpose
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.

Condition
Epilepsy

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Post Market, Long Term, Prospective, Observational, Multi-site Outcome Study to Follow the Clinical Course and Seizure Reduction of Patients With Refractory Seizures Who Are Being Treated With Adjunctive VNS Therapy.

Resource links provided by NLM:


Further study details as provided by Cyberonics, Inc.:

Primary Outcome Measures:
  • Two-Year Clinical Follow-up [ Time Frame: 27 months ]
    To follow the clinical course of patients with refractory seizures treated with adjunctive VNS Therapy over a two-year follow-up period.


Secondary Outcome Measures:
  • Efficacy and Safety [ Time Frame: 27 months ]
    1. To evaluate over time the efficacy of best medical practice with adjunctive VNS Therapy in patients with refractory seizures.
    2. To evaluate over time the safety and tolerability of best medical practice with adjunctive VNS Therapy in patients with refractory seizures.


Enrollment: 124
Actual Study Start Date: January 2011
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: October 2018 (Final data collection date for primary outcome measure)
Detailed Description:
Minimum ages eligible for the E-103 study is at least 7 years outside of the US, consistent with "Non-US" labeling and 12 years for sites in the US.
  Eligibility

Ages Eligible for Study:   7 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

Inclusion Criteria:

Patients enrolled in the study must meet all of the following criteria at Visit 1:

(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:

Patients with any of the following will not be eligible for enrollment:

  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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01281293

Locations
United States, Georgia
Emory Healthcare
Atlanta, Georgia, United States, 30322
United States, Illinois
University of Illinois College of Medicine at Peoria
Peoria, Illinois, United States, 61656-1649
United States, Kentucky
University of Louisville Hospital
Louisville, Kentucky, United States, 40202
United States, New York
Cornell University
New York, New York, United States, 10065
United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
United States, Texas
Covenant Hospital
Lubbock, Texas, United States, 79410
United States, Wisconsin
St. Luke's Milwaukee
Milwaukee, Wisconsin, United States, 53215
Belgium
UZ Gasthuisberg
Leuven, Belgium
Germany
Epilepsieklinik Tabor - Ladeburger Straße 15
Berlin, Germany
Albert-Ludwigs-Universität Freiburg
Freiburg, Germany
Universitätsklinikum Schleswig-Holstein Campus Kiel
Kiel, Germany
Israel
Sheba Medical Center
Ramat Gan, Israel
United Kingdom
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
Sponsors and Collaborators
Cyberonics, Inc.
Investigators
Study Director: Wim Van Grunderbeek LivaNova
  More Information

Responsible Party: Cyberonics, Inc.
ClinicalTrials.gov Identifier: NCT01281293     History of Changes
Other Study ID Numbers: Epilepsy (E)-103  E-103 
Study First Received: January 5, 2011
Last Updated: February 10, 2017

Keywords provided by Cyberonics, Inc.:
V-COMPAS; Vagus Nerve Stimulation Clinical Outcomes;

ClinicalTrials.gov processed this record on February 20, 2017