Overview

This trial is active, not recruiting.

Conditions epilepsy, seizures
Treatment vagus nerve stimulation therapy
Sponsor Cyberonics, Inc.
Start date March 2015
End date October 2016
Trial size 60 participants
Trial identifier NCT02385526, E-40

Summary

Post-market, on-label, double-blind, randomized, prospective, interventional, tolerability and clinical outcomes study to determine the number of patients achieving their final assigned VNS Therapy dose settings in patients with drug-resistant epilepsy who are being treated with adjunctive VNS Therapy using new titration protocols.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
Vagus Nerve Stimulation Therapy Standard Titration
vagus nerve stimulation therapy VNS Therapy
Stimulation of the left tenth cranial nerve via VNS Therapy
Vagus Nerve Stimulation Therapy Alternate Titration 1
vagus nerve stimulation therapy VNS Therapy
Stimulation of the left tenth cranial nerve via VNS Therapy
Vagus Nerve Stimulation Therapy Alternate Titration 2
vagus nerve stimulation therapy VNS Therapy
Stimulation of the left tenth cranial nerve via VNS Therapy

Primary Outcomes

Measure
Percent patients reaching the defined therapeutic dose
time frame: 12 weeks post implant

Eligibility Criteria

Male or female participants at least 12 years old.

Inclusion Criteria: 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 must be 12 years or older and have partial onset seizures or must follow the indication for use statement for VNS Therapy. 3. Patient and/or caregiver must be able and willing to give accurate side effect reports, global impressions data and complete study instruments with minimal assistance throughout the study. 4. Patient or legal guardian understands study procedures and voluntarily signs an informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization in accordance with institutional policies. In the event the patient is under the age of 18, the patient will also be required to sign an assent affirming agreement to participate in research according to local IRB requirements. 5. Patient must be taking at least 1 anti-epileptic drug treatment 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 MRI using a body coil for transmission of RF during the clinical study. 3. Patient has a progressive neurological condition (e.g. brain tumor etc.). 4. In the investigator's opinion, the patient or legal guardian is unable to comply with the frequency of clinic visits during the study. 5. Patient is currently using an investigational device or pharmacologic medication not approved by the FDA. 6. Patient was previously implanted with VNS Therapy. 7. In the investigator's opinion, the patient is considered a suicide risk or is otherwise not a good candidate for this study. 8. Patient/Caregiver is unable to complete the required study follow-up visits and assessments.

Additional Information

Official title ASCEND: Vagus Nerve Stimulation Titration Protocol to Improve Tolerance and Accelerate Adaptation
Description Post-market, on-label, double-blind, randomized, prospective, interventional, tolerability and clinical outcomes study is designed to determine which VNS Therapy titration paradigm allows more patients to achieve a therapeutic dose within a specified time frame. Additionally, the study will collect data on the acute tolerability and clinical outcomes for patients with drug-resistant epilepsy treated with adjunctive VNS Therapy employing three different titration paradigms.
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Cyberonics, Inc..