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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02385526
Recruitment Status : Completed
First Posted : March 11, 2015
Results First Posted : July 23, 2018
Last Update Posted : July 23, 2018
Sponsor:
Information provided by (Responsible Party):
LivaNova ( Cyberonics, Inc. )

Study Description
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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.

Condition or disease Intervention/treatment
Epilepsy Seizures 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 Design
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Study Type : Observational
Actual Enrollment : 67 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: ASCEND: Vagus Nerve Stimulation Titration Protocol to Improve Tolerance and Accelerate Adaptation
Actual Study Start Date : April 28, 2015
Actual Primary Completion Date : October 10, 2016
Actual Study Completion Date : October 10, 2016

Resource links provided by the National Library of Medicine


Groups and Cohorts
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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 Name: 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 Name: 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 Name: VNS Therapy


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


Eligibility Criteria
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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02385526


Locations
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United States, Arizona
Barrow Neurological Institute
Phoenix, Arizona, United States, 85013
United States, California
Loma Linda University
Loma Linda, California, United States, 92354
University of Southern California
Los Angeles, California, United States, 90033
United States, Florida
Tampa General Hospital
Tampa, Florida, United States, 33606
United States, Georgia
Emory University
Atlanta, Georgia, United States, 30329
United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
Rush University Medical Center
Chicago, Illinois, United States, 60612
United States, Kentucky
St. Joseph's Hospital
Lexington, Kentucky, United States, 40504
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
United States, Missouri
Mercy Medical Research Institue
Springfield, Missouri, United States, 65804
United States, Nebraska
University of Nebraska
Omaha, Nebraska, United States, 68131
United States, Pennsylvania
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213
United States, Texas
Covenant Hospital
Lubbock, Texas, United States, 79410
Scott & White Healthcare
Temple, Texas, United States, 76508
United States, Utah
University of Utah
Salt Lake City, Utah, United States, 84132
Sponsors and Collaborators
Cyberonics, Inc.
Investigators
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Study Director: Jeff Way Cyberonics, Inc.
More Information
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Responsible Party: Cyberonics, Inc.
ClinicalTrials.gov Identifier: NCT02385526    
Other Study ID Numbers: E-40
First Posted: March 11, 2015    Key Record Dates
Results First Posted: July 23, 2018
Last Update Posted: July 23, 2018
Last Verified: October 2017
Keywords provided by LivaNova ( Cyberonics, Inc. ):
Vagus Nerve Stimulation
ASCEND
VNS Titration to Improve Tolerance and Accelerate Adaptation
Additional relevant MeSH terms:
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Seizures
Nervous System Diseases
Neurologic Manifestations