Vagus Nerve Stimulation Titration Protocol to Improve Tolerance and Accelerate Adaptation

Completed

Conditions studied: Epilepsy, Seizures

In brief

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.

Key facts

Study ID

NCT02385526

Run by

Cyberonics, Inc.

People needed

67

Starts

2015-04-28

Expected to finish

2016-10-10

Last updated by the study team

2018-07-23

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• Barrow Neurological Institute — Phoenix, Arizona, United States
• Loma Linda University — Loma Linda, California, United States
• University of Southern California — Los Angeles, California, United States
• Tampa General Hospital — Tampa, Florida, United States
• Emory University — Atlanta, Georgia, United States
• Northwestern University — Chicago, Illinois, United States
• Rush University Medical Center — Chicago, Illinois, United States
• St. Joseph's Hospital — Lexington, Kentucky, United States
• University of Michigan — Ann Arbor, Michigan, United States
• Mercy Medical Research Institue — Springfield, Missouri, United States
• University of Nebraska — Omaha, Nebraska, United States
• University of Pittsburgh — Pittsburgh, Pennsylvania, United States
• Covenant Hospital — Lubbock, Texas, United States
• Scott & White Healthcare — Temple, Texas, United States
• University of Utah — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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