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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P25-P50 for all trials

Timeline

Completed

Started Apr 2015

Geographic Reach

1 country

15 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

1.5 years study duration

First Submitted

Initial submission to the registry

March 5, 2015

Completed

6 days until next milestone

First Posted

Study publicly available on registry

March 11, 2015

Completed

2 months until next milestone

Study Start

First participant enrolled

April 28, 2015

Completed

1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 10, 2016

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 10, 2016

Completed

1.8 years until next milestone

Results Posted

Study results publicly available

July 23, 2018

Completed

Last Updated

July 23, 2018

Status Verified

October 1, 2017

Enrollment Period

1.5 years

First QC Date

March 5, 2015

Results QC Date

May 17, 2017

Last Update Submit

October 3, 2017

Conditions

Epilepsy Seizures

Keywords

Vagus Nerve StimulationASCENDVNS Titration to Improve Tolerance and Accelerate Adaptation

Outcome Measures

Primary Outcomes (1)

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

Study Arms (3)

Group A

Vagus Nerve Stimulation Therapy Standard Titration

Device: Vagus Nerve Stimulation Therapy

Group B

Vagus Nerve Stimulation Therapy Alternate Titration 1

Device: Vagus Nerve Stimulation Therapy

Group C

Vagus Nerve Stimulation Therapy Alternate Titration 2

Device: Vagus Nerve Stimulation Therapy

Interventions

Vagus Nerve Stimulation TherapyDEVICE

Stimulation of the left tenth cranial nerve via VNS Therapy

Also known as: VNS Therapy

Group AGroup BGroup C

Eligibility Criteria

Age12 Years+

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

Sampling MethodProbability 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.

You may qualify if:

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.
Patients must be 12 years or older and have partial onset seizures or must follow the indication for use statement for VNS Therapy.
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.
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.
Patient must be taking at least 1 anti-epileptic drug treatment

You may not qualify if:

Patient currently uses, or is expected to use during the study, short-wave diathermy, microwave diathermy, or therapeutic ultrasound diathermy.
Patient is expected to require MRI using a body coil for transmission of RF during the clinical study.
Patient has a progressive neurological condition (e.g. brain tumor etc.).
In the investigator's opinion, the patient or legal guardian is unable to comply with the frequency of clinic visits during the study.
Patient is currently using an investigational device or pharmacologic medication not approved by the FDA.
Patient was previously implanted with VNS Therapy.
In the investigator's opinion, the patient is considered a suicide risk or is otherwise not a good candidate for this study.
Patient/Caregiver is unable to complete the required study follow-up visits and assessments.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Cyberonics, Inc.lead

Study Sites (15)

Barrow Neurological Institute

Phoenix, Arizona, 85013, United States

Location

Loma Linda University

Loma Linda, California, 92354, United States

Location

University of Southern California

Los Angeles, California, 90033, United States

Location

Tampa General Hospital

Tampa, Florida, 33606, United States

Location

Emory University

Atlanta, Georgia, 30329, United States

Location

Northwestern University

Chicago, Illinois, 60611, United States

Location

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

St. Joseph's Hospital

Lexington, Kentucky, 40504, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Mercy Medical Research Institue

Springfield, Missouri, 65804, United States

Location

University of Nebraska

Omaha, Nebraska, 68131, United States

Location

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

Covenant Hospital

Lubbock, Texas, 79410, United States

Location

Scott & White Healthcare

Temple, Texas, 76508, United States

Location

University of Utah

Salt Lake City, Utah, 84132, United States

Location

Related Publications (1)

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.
PMID: 37429122DERIVED

MeSH Terms

Conditions

EpilepsySeizures

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Results Point of Contact

Title: Peter Sears, Clinical Project Manager
Organization: Cyberonics, Inc.

Study Officials

Jeff Way
Cyberonics, Inc.
STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee: No
Restriction Type: GT60
Restrictive Agreement: Yes

Study Design

Study Type: observational
Observational Model: COHORT
Time Perspective: PROSPECTIVE
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

March 5, 2015

First Posted

March 11, 2015

Study Start

April 28, 2015

Primary Completion

October 10, 2016

Study Completion

October 10, 2016

Last Updated

July 23, 2018

Results First Posted

July 23, 2018

Record last verified: 2017-10

Locations

US(15)

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Study Arms (3)

Group A

Group B

Group C

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (15)

Related Publications (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Study Design

Study Record Dates

Locations