Vagus Nerve Stimulation Titration Protocol to Improve Tolerance and Accelerate Adaptation
This trial is active, not recruiting.
|Treatment||vagus nerve stimulation therapy|
|Start date||March 2015|
|End date||October 2016|
|Trial size||60 participants|
|Trial identifier||NCT02385526, E-40|
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.
|United States||No locations recruiting|
|Other countries||No locations recruiting|
|Phoenix, AZ||Barrow Neurological Institute||no longer recruiting|
|Loma Linda, CA||Loma Linda University||no longer recruiting|
|Los Angeles, CA||University of Southern California||no longer recruiting|
|Tampa, FL||Tampa General Hospital||no longer recruiting|
|Atlanta, GA||Emory University||no longer recruiting|
|Chicago, IL||Northwestern University||no longer recruiting|
|Chicago, IL||Rush University Medical Center||no longer recruiting|
|Lexington, KY||St. Joseph's Hospital||no longer recruiting|
|Ann Arbor, MI||University of Michigan||no longer recruiting|
|Springfield, MO||Mercy Medical Research Institue||no longer recruiting|
|Omaha, NE||University of Nebraska||no longer recruiting|
|Pittsburgh, PA||University of Pittsburgh||no longer recruiting|
|Lubbock, TX||Covenant Hospital||no longer recruiting|
|Temple, TX||Scott & White Healthcare||no longer recruiting|
|Salt Lake City, UT||University of Utah||no longer recruiting|
Percent patients reaching the defined therapeutic dose
time frame: 12 weeks post implant
All participants at least 12 years old.
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.
|Official title||ASCEND: Vagus Nerve Stimulation Titration Protocol to Improve Tolerance and Accelerate Adaptation|
|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.|
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