VNS Therapy Automatic Magnet Mode Outcomes Study in Epilepsy Patients Exhibiting Ictal Tachycardia (E-37)

NCT01846741 | Completed Results

• 1 other identifier: Epilepsy (E)-37
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 15

Brief Summary

Obtain baseline clinical outcome data (Stage 1) upon which to base a subsequent study (Stage 2) of the Model 106 VNS implantable pulse generator

Conditions

Epilepsy

Keywords

Automatic Magnet Mode (AMM); Vagus Nerve Stimulation (VNS)

Outcome Measures

Primary Outcomes (1)

• Estimate the Effect Size Associated With Objective Measures and Patient Self-reports of Clinical Outcomes Including Seizure Frequency, Seizure Severity, Seizure Duration, Seizure Intensity, and Post-ictal Duration.

  The purpose for determining the effect size was to power a stage 2 study. At the conclusion of stage 1 of the E-37 study, it was determined that another study would not be necessary as it would not provide incremental clinical benefit information above what has already been collected. Therefore, computation of effect size was not necessary.

  Up to 18 Month Visit-End of Study

Secondary Outcomes (17)

• Summary of Seizures Reported by Investigators and Triple Review

  Epilepsy Monitoring Unit (EMU) Stay

• Assess Performance of the Tachycardia Detection Algorithm (Sensitivity) During an EMU Stay Based on ITT Population-Observed

  Epilepsy Monitoring Unit (EMU) Stay

• Assess Performance of the Tachycardia Detection Algorithm (Sensitivity) During an EMU Stay Based on ITT Population-Modeled

  Epilepsy Monitoring Unit (EMU) Stay

• Assess Non-seizure Related Stimulation Rate Per Hour During EMU Stay and Stair Stepper Exercise Periods

  Epilepsy Monitoring Unit (EMU) Stay

• Assess Characterization of Seizures (Duration and Cessation)

  Epilepsy Monitoring Unit (EMU) Stay

Study Arms (1)

Model 106 VNS Therapy System

OTHER

Device: M106 VNS Therapy System

Interventions

M106 VNS Therapy System DEVICE

Model 106 VNS Therapy System

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with a clinical diagnosis of medically refractory epilepsy with partial onset seizures suitable for implantation with the VNS Therapy System.
• Patients willing to undergo an EMU evaluation for a period of at least three days with activation of the AMM feature during that time.
• Patients must be at least 12 years old.
• Patients must be in good general health and ambulatory.
• Patient or guardian must be willing and able to complete informed consent/assent.

You may not qualify if:

• Patients have had a bilateral or left cervical vagotomy.
• Patients currently using, or are expected to use, short-wave diathermy, microwave diathermy, or therapeutic ultrasound diathermy.
• A VNS Therapy System implant would (in the investigator's judgment) pose an unacceptable surgical or medical risk for the patient.
• Patients expected to require full body magnetic resonance imaging (MRI).
• Patients have a history of implantation of the VNS Therapy.
• Patients with an IQ known or estimated to be \< 70, history of depression requiring hospitalization, or suicidality as defined by DSM IV-TR that in the investigator's judgment would pose an unacceptable risk for the patient or prevent the patient's successful completion of the study.
• Patients with a history of status epilepticus within 1 year of study enrollment.
• Patients with known clinically meaningful cardiovascular arrhythmias as well as patients with clinically meaningful cardiovascular arrhythmias determined by a 24-hour Holter recording obtained during the baseline period.
• Patients dependent on alcohol or narcotic drugs as defined by DSM IV-TR within the past 2 years.
• Patients with a history of psychogenic non-epileptic seizures.
• Women who are pregnant. Women of childbearing age must take a pregnancy test and agree to use an approved method of contraception during the study.
• Patients currently enrolled in another investigational study.

Sponsors & Collaborators

• Cyberonics, Inc.: lead

Study Sites (15)

Unknown Facility

Phoenix, Arizona, United States

Location

Unknown Facility

Stanford, California, United States

Location

Unknown Facility

Tampa, Florida, United States

Location

Unknown Facility

Atlanta, Georgia, United States

Location

Unknown Facility

Chicago, Illinois, United States

Location

Unknown Facility

Ann Arbor, Michigan, United States

Location

Unknown Facility

Saint Paul, Minnesota, United States

Location

Unknown Facility

Kansas City, Missouri, United States

Location

Unknown Facility

Albany, New York, United States

Location

Unknown Facility

Durham, North Carolina, United States

Location

Unknown Facility

Pittsburgh, Pennsylvania, United States

Location

Unknown Facility

Memphis, Tennessee, United States

Location

Unknown Facility

Dallas, Texas, United States

Location

Unknown Facility

Houston, Texas, United States

Location

Unknown Facility

Salt Lake City, Utah, United States

Location

MeSH Terms

Conditions

Epilepsy

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Limitations and Caveats

The small sample size and the absence of randomization did not allow conclusions about whether the AutoStim alone, or the combination of AutoStim and traditional VNS therapy modes, or some other factor was a cause of the observed beneficial effects.

Results Point of Contact

• Title: Bita Najimipour, Clinical Study Manager
• Organization: Cyberonics, Inc.

bita.najimipour@cyberonics.com

(281) 228-7370

Study Officials

• Jason Begnaud

  Cyberonics, Inc.

  STUDY DIRECTOR

• Robert Fisher, MD, PhD

  Stanford University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2013
• First Posted: May 3, 2013
• Study Start: July 1, 2013
• Primary Completion: August 1, 2014
• Study Completion: August 1, 2015
• Last Updated: November 24, 2015
• Results First Posted: July 14, 2015

Record last verified: 2015-10

Locations

US (15)