Vagus Nerve Stimulation Titration Protocol to Improve Tolerance and Accelerate Adaptation (ASCEND)

ASCEND: Vagus Nerve Stimulation Titration Protocol to Improve Tolerance and Accelerate Adaptation

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.

Study Overview

• Status: Completed
• Conditions: Epilepsy; Seizures
• Intervention / Treatment: Device: Vagus Nerve Stimulation Therapy

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 67

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85013
      • Barrow Neurological Institute
  • California
    • Loma Linda, California, United States, 92354
      • Loma Linda University
    • Los Angeles, California, United States, 90033
      • University of Southern California
  • Florida
    • Tampa, Florida, United States, 33606
      • Tampa General Hospital
  • Georgia
    • Atlanta, Georgia, United States, 30329
      • Emory University
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern University
    • Chicago, Illinois, United States, 60612
      • Rush University Medical Center
  • Kentucky
    • Lexington, Kentucky, United States, 40504
      • St. Joseph's Hospital
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan
  • Missouri
    • Springfield, Missouri, United States, 65804
      • Mercy Medical Research Institue
  • Nebraska
    • Omaha, Nebraska, United States, 68131
      • University of Nebraska
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • University of Pittsburgh
  • Texas
    • Lubbock, Texas, United States, 79410
      • Covenant Hospital
    • Temple, Texas, United States, 76508
      • Scott & White Healthcare
  • Utah
    • Salt Lake City, Utah, United States, 84132
      • University of Utah

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

The study shall include adults and adolescents over 12 years of age with partial onset seizures that are refractory to antiepileptic medications and eligible for VNS Therapy indicated for use as an adjunctive therapy in reducing the frequency of seizures.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group A; Vagus Nerve Stimulation Therapy Standard Titration	Device: Vagus Nerve Stimulation Therapy; Stimulation of the left tenth cranial nerve via VNS Therapy; Other Names: VNS Therapy
Group B; Vagus Nerve Stimulation Therapy Alternate Titration 1	Device: Vagus Nerve Stimulation Therapy; Stimulation of the left tenth cranial nerve via VNS Therapy; Other Names: VNS Therapy
Group C; Vagus Nerve Stimulation Therapy Alternate Titration 2	Device: Vagus Nerve Stimulation Therapy; Stimulation of the left tenth cranial nerve via VNS Therapy; Other Names: VNS Therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent Patients Reaching the Defined Target Dose	Determination of the proportion (percent) of patients in each VNS Therapy titration group reaching the defined target dose within clinically defined titration time-frame	12 weeks post implant

Collaborators and Investigators

• Sponsor: Cyberonics, Inc.
• Investigators: Study Director: Jeff Way, Cyberonics, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): April 28, 2015
• Primary Completion (Actual): October 10, 2016
• Study Completion (Actual): October 10, 2016

Study Registration Dates

• First Submitted: March 5, 2015
• First Submitted That Met QC Criteria: March 10, 2015
• First Posted (Estimate): March 11, 2015

Study Record Updates

• Last Update Posted (Actual): July 23, 2018
• Last Update Submitted That Met QC Criteria: October 3, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Keywords: Vagus Nerve Stimulation; ASCEND; VNS Titration to Improve Tolerance and Accelerate Adaptation
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Seizures
• Other Study ID Numbers: E-40