Clinical trial NCT02385526: Vagus Nerve Stimulation Titration Protocol to Improve Tolerance and Accelerate Adaptation
Official title: ASCEND: Vagus Nerve Stimulation Titration Protocol to Improve Tolerance and Accelerate Adaptation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Epilepsy
Seizures
Keywords: Vagus Nerve Stimulation
ASCEND
VNS Titration to Improve Tolerance and Accelerate Adaptation
Lead sponsor: LivaNova
Sponsor class: INDUSTRY
First posted: 2015-03-11
Enrollment: 67
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Primary outcomes:
measure: Percent Patients Reaching the Defined Target Dose
timeFrame: 12 weeks post implant
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Barrow Neurological Institute
state: Arizona
city: Loma Linda
country: United States
facility: Loma Linda University
state: California
city: Los Angeles
country: United States
facility: University of Southern California
state: California
city: Tampa
country: United States
facility: Tampa General Hospital
state: Florida
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Lexington
country: United States
facility: St. Joseph's Hospital
state: Kentucky
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Springfield
country: United States
facility: Mercy Medical Research Institue
state: Missouri
city: Omaha
country: United States
facility: University of Nebraska
state: Nebraska
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
city: Lubbock
country: United States
facility: Covenant Hospital
state: Texas
city: Temple
country: United States
facility: Scott & White Healthcare
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
Study officials:
affiliation: Cyberonics, Inc.
name: Jeff Way
role: STUDY_DIRECTOR
References: