Vagus Nerve Stimulation Titration Protocol to Improve Tolerance and Accelerate Adaptation
ASCEND
ASCEND: Vagus Nerve Stimulation Titration Protocol to Improve Tolerance and Accelerate Adaptation
1 other identifier
observational
67
1 country
15
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Apr 2015
15 active sites
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
First Submitted
Initial submission to the registry
March 5, 2015
CompletedFirst Posted
Study publicly available on registry
March 11, 2015
CompletedStudy Start
First participant enrolled
April 28, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 10, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
October 10, 2016
CompletedResults Posted
Study results publicly available
July 23, 2018
CompletedJuly 23, 2018
October 1, 2017
1.5 years
March 5, 2015
May 17, 2017
October 3, 2017
Conditions
Keywords
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
Group B
Vagus Nerve Stimulation Therapy Alternate Titration 1
Group C
Vagus Nerve Stimulation Therapy Alternate Titration 2
Interventions
Stimulation of the left tenth cranial nerve via VNS Therapy
Eligibility Criteria
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
Loma Linda University
Loma Linda, California, 92354, United States
University of Southern California
Los Angeles, California, 90033, United States
Tampa General Hospital
Tampa, Florida, 33606, United States
Emory University
Atlanta, Georgia, 30329, United States
Northwestern University
Chicago, Illinois, 60611, United States
Rush University Medical Center
Chicago, Illinois, 60612, United States
St. Joseph's Hospital
Lexington, Kentucky, 40504, United States
University of Michigan
Ann Arbor, Michigan, 48109, United States
Mercy Medical Research Institue
Springfield, Missouri, 65804, United States
University of Nebraska
Omaha, Nebraska, 68131, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213, United States
Covenant Hospital
Lubbock, Texas, 79410, United States
Scott & White Healthcare
Temple, Texas, 76508, United States
University of Utah
Salt Lake City, Utah, 84132, United States
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
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Peter Sears, Clinical Project Manager
- Organization
- Cyberonics, Inc.
Study Officials
- STUDY DIRECTOR
Jeff Way
Cyberonics, Inc.
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