VNS Therapy Automatic Magnet Mode Outcomes Study in Epilepsy Patients Exhibiting Ictal Tachycardia (E-37)
NCT ID: NCT01846741
Last Updated: 2015-11-24
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
NA
20 participants
INTERVENTIONAL
2013-07-31
2015-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Model 106 VNS Therapy System
M106 VNS Therapy System
Interventions
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M106 VNS Therapy System
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
12 Years
ALL
No
Sponsors
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Cyberonics, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Jason Begnaud
Role: STUDY_DIRECTOR
Cyberonics, Inc.
Robert Fisher, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Stanford University
Locations
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Phoenix, Arizona, United States
Stanford, California, United States
Tampa, Florida, United States
Atlanta, Georgia, United States
Chicago, Illinois, United States
Ann Arbor, Michigan, United States
Saint Paul, Minnesota, United States
Kansas City, Missouri, United States
Albany, New York, United States
Durham, North Carolina, United States
Pittsburgh, Pennsylvania, United States
Memphis, Tennessee, United States
Dallas, Texas, United States
Houston, Texas, United States
Salt Lake City, Utah, United States
Countries
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Other Identifiers
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Epilepsy (E)-37
Identifier Type: -
Identifier Source: org_study_id