Clinical trial NCT01281293: Vagus Nerve Stimulation Clinical Outcomes Measured Prospectively in Patients Stimulated
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.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Epilepsy
Keywords: V-COMPAS; Vagus Nerve Stimulation Clinical Outcomes;
Lead sponsor: LivaNova
Sponsor class: INDUSTRY
First posted: 2011-01-21
Enrollment: 124
Sex: ALL
Minimum age (years): 7
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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 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.

Primary outcomes:
measure: Two-Year Clinical Follow-up
timeFrame: 27 months
Secondary outcomes:
measure: Efficacy and Safety
timeFrame: 27 months
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory Healthcare
state: Georgia
city: Peoria
country: United States
facility: University of Illinois College of Medicine at Peoria
state: Illinois
city: Louisville
country: United States
facility: University of Louisville Hospital
state: Kentucky
city: New York
country: United States
facility: Cornell University
state: New York
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Lubbock
country: United States
facility: Covenant Hospital
state: Texas
city: Milwaukee
country: United States
facility: St. Luke's Milwaukee
state: Wisconsin
city: Leuven
country: Belgium
facility: UZ Gasthuisberg
city: Berlin
country: Germany
facility: Epilepsieklinik Tabor - Ladeburger Straße 15
city: Freiburg
country: Germany
facility: Albert-Ludwigs-Universität Freiburg
city: Kiel
country: Germany
facility: Universitätsklinikum Schleswig-Holstein Campus Kiel
city: Ramat Gan
country: Israel
facility: Sheba Medical Center
city: Birmingham
country: United Kingdom
facility: Birmingham Children's Hospital
city: Birmingham
country: United Kingdom
facility: Foundation Trust Queen Elizabeth Hospital Birmingham
city: Bristol
country: United Kingdom
facility: Southmead Hospital Bristol
city: London
country: United Kingdom
facility: Great Ormond Street Hospital for Children NHS Foundation Trust
city: London
country: United Kingdom
facility: National Hospital for Neurology & Neurosurgery - UCLH
city: Oxford
country: United Kingdom
facility: John Radcliffe Hospital
city: Salford
country: United Kingdom
facility: Salford Royal Hospital
city: Sheffield
country: United Kingdom
facility: Royal Hallamshire Hospital
Study officials:
affiliation: LivaNova
name: Jason Jones
role: STUDY_DIRECTOR
References: