Vagus Nerve Stimulation Titration Protocol to Improve Tolerance and Accelerate Adaptation

NCT ID: NCT02385526

Last Updated: 2018-07-23

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 67 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-04-28
• Study Completion Date: 2016-10-10

Brief 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.

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.

Conditions

Epilepsy; Seizures

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Group A

Vagus Nerve Stimulation Therapy Standard Titration

Vagus Nerve Stimulation Therapy

Intervention Type: DEVICE

Stimulation of the left tenth cranial nerve via VNS Therapy

Group B

Vagus Nerve Stimulation Therapy Alternate Titration 1

Vagus Nerve Stimulation Therapy

Intervention Type: DEVICE

Stimulation of the left tenth cranial nerve via VNS Therapy

Group C

Vagus Nerve Stimulation Therapy Alternate Titration 2

Vagus Nerve Stimulation Therapy

Intervention Type: DEVICE

Stimulation of the left tenth cranial nerve via VNS Therapy

Interventions

Vagus Nerve Stimulation Therapy

Stimulation of the left tenth cranial nerve via VNS Therapy

Intervention Type: DEVICE

Other Intervention Names

VNS Therapy

Eligibility Criteria

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.

• Minimum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cyberonics, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jeff Way

Role: STUDY_DIRECTOR

Cyberonics, Inc.

Locations

Barrow Neurological Institute

Phoenix, Arizona, United States

Loma Linda University

Loma Linda, California, United States

University of Southern California

Los Angeles, California, United States

Tampa General Hospital

Tampa, Florida, United States

Emory University

Atlanta, Georgia, United States

Northwestern University

Chicago, Illinois, United States

Rush University Medical Center

Chicago, Illinois, United States

St. Joseph's Hospital

Lexington, Kentucky, United States

University of Michigan

Ann Arbor, Michigan, United States

Mercy Medical Research Institue

Springfield, Missouri, United States

University of Nebraska

Omaha, Nebraska, United States

University of Pittsburgh

Pittsburgh, Pennsylvania, United States

Covenant Hospital

Lubbock, Texas, United States

Scott & White Healthcare

Temple, Texas, United States

University of Utah

Salt Lake City, Utah, United States

Countries

United States

References

Bagic AI, Verner R, Afra P, Benbadis S; ASCEND Study Group. ASCEND: A randomized controlled trial of titration strategies for vagus nerve stimulation in drug-resistant epilepsy. Epilepsy Behav. 2023 Aug;145:109333. doi: 10.1016/j.yebeh.2023.109333. Epub 2023 Jul 8.

Reference Type: DERIVED

PMID: 37429122 (View on PubMed)

Other Identifiers

E-40

Identifier Type: -

Identifier Source: org_study_id