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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2015 by Cyberonics, Inc.
Information provided by (Responsible Party):
Cyberonics, Inc. Identifier:
First received: January 5, 2011
Last updated: March 23, 2015
Last verified: March 2015

Vagal 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.


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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.

Estimated Enrollment: 600
Study Start Date: January 2011
Estimated Study Completion Date: October 2016
Estimated Primary Completion Date: April 2016 (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.


Ages Eligible for Study:   7 Years and older
Genders Eligible for Study:   Both
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.


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 identifier: NCT01281293

Contact: Mark Bunker, PharmD 281-228-7223

United States, Georgia
Emory Healthcare Recruiting
Atlanta, Georgia, United States, 30322
Contact: Melanee Newman, RN    404-778-4249   
Principal Investigator: Sandra Helmers, MD         
United States, Illinois
University of Illinois College of Medicine at Peoria Terminated
Peoria, Illinois, United States, 61656-1649
United States, Kentucky
University of Louisville Hospital Active, not recruiting
Louisville, Kentucky, United States, 40202
United States, New York
Columbia University Recruiting
New York, New York, United States, 10032
Contact: James Carter    212-746-2474   
Principal Investigator: Steven Karceski, MD         
United States, Pennsylvania
University of Pennsylvania Withdrawn
Philidelphia, Pennsylvania, United States, 19104
United States, Tennessee
Vanderbilt University Medical Center Recruiting
Nashville, Tennessee, United States, 37232
Contact: Kelly Lowen    615-936-0209    kelly.m.lowen@Vanderbilt.Edu   
Principal Investigator: Bassel Abou-Khalil, MD         
United States, Texas
Dell Children's Medical Center of Central Texas Withdrawn
Austin, Texas, United States, 78723
Texas Children's Hospital Withdrawn
Houston, Texas, United States, 77030
Covenant Hospital Recruiting
Lubbock, Texas, United States, 79410
Contact: Roy Hendley   
Principal Investigator: Kalarickal Oommen, MD         
United States, Wisconsin
St. Luke's Milwaukee Active, not recruiting
Milwaukee, Wisconsin, United States, 53215
Neurologische Abteilung Krankenhaus Rosenhügel Withdrawn
Wien, Austria
UZ Gasthuisberg Recruiting
Leuven, Belgium
Contact: An Verstrepen    0032 16 34 38 45   
Principal Investigator: Lieven Lagae         
Epilepsieklinik Tabor - Ladeburger Straße 15 Recruiting
Berlin, Germany
Contact: Martina Steinke, R.N.    0049+3338 752401   
Principal Investigator: Hans-Beatus Straub         
Albert-Ludwigs-Universität Freiburg Recruiting
Freiburg, Germany
Contact: Alena Tränkle    +49 761 270 53660   
Principal Investigator: Andreas Schulze-Bonhage         
Universitatsklinikum Schleswig-Holstein Campus Kiel Recruiting
Kiel, Germany
Contact: Birte Hackelberg    0049(0)431 597-8519   
Principal Investigator: Nicolas Lang         
Sheba Medical Center Recruiting
Ramat Gan, Israel
Contact: Efra Rogowski    +972 54 4610683   
Principal Investigator: Dr. Bruria Ben Zeev         
United Kingdom
Birmingham Children's Hospital Recruiting
Birmingham, United Kingdom
Contact: Alison Corbett    +44 (0) 121 333 8739   
Contact: Bernie Concannon    +44 (0) 121 333 8739   
Principal Investigator: Dr. Sunny Philip         
Foundation Trust Queen Elizabeth Hospital Birmingham Recruiting
Birmingham, United Kingdom
Contact: Rachel Hornabrook    +44 121 371 4821   
Principal Investigator: Imad Soryal         
Southmead Hospital Bristol Recruiting
Bristol, United Kingdom
Contact: Samantha Travis    +44 (0) 117 414 6686   
Principal Investigator: Dr. Kasia Sieradzan         
John Radcliffe Hospital Recruiting
Oxford, United Kingdom
Contact: Samantha Chilcott    +44 (0) 186 523 2556   
Contact: Claire Hall    +44 (0) 186 523 2556   
Principal Investigator: Dr. Arjune Sen         
Salford Royal Hospital Recruiting
Salford, United Kingdom
Contact: Victoria Parker    +44(0) 161 206 0531   
Principal Investigator: Dr. Rajiv Mohanraj         
Royal Hallamshire Hospital Recruiting
Sheffield, United Kingdom
Contact: Pene Fati    +44 (0) 114 271 3339   
Contact: Kamel Bouakline    +44 (0) 114 271 3339   
Principal Investigator: Dr. Markus Reuber         
Sponsors and Collaborators
Cyberonics, Inc.
Study Director: Mark Bunker, PharmD Cyberonics, Inc.
  More Information

No publications provided

Responsible Party: Cyberonics, Inc. Identifier: NCT01281293     History of Changes
Other Study ID Numbers: Epilepsy (E)-103, E-103
Study First Received: January 5, 2011
Last Updated: March 23, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by Cyberonics, Inc.:
V-COMPAS; Vagus Nerve Stimulation Clinical Outcomes; processed this record on March 26, 2015