Vagus Nerve Stimulation Titration Protocol to Improve Tolerance and Accelerate Adaptation

Epilepsy Clinical Trial

— ASCEND  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02385526
• Other study ID #: E-40
• Status: Completed
• Start date: April 28, 2015
• Est. completion date: October 10, 2016

Study information

• Verified date: October 2017
• Source: LivaNova
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 67
• Est. completion date: October 10, 2016
• Est. primary completion date: October 10, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Epilepsy
• Seizures

Intervention

Device:
• Vagus Nerve Stimulation Therapy
Stimulation of the left tenth cranial nerve via VNS Therapy

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan
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	Loma Linda University	Loma Linda	California
United States	University of Southern California	Los Angeles	California
United States	Covenant Hospital	Lubbock	Texas
United States	University of Nebraska	Omaha	Nebraska
United States	Barrow Neurological Institute	Phoenix	Arizona
United States	University of Pittsburgh	Pittsburgh	Pennsylvania
United States	University of Utah	Salt Lake City	Utah
United States	Mercy Medical Research Institue	Springfield	Missouri
United States	Tampa General Hospital	Tampa	Florida
United States	Scott & White Healthcare	Temple	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Cyberonics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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