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

Completed · Not applicable

Conditions studied: Epilepsy

In brief

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

Key facts

Study ID

NCT01846741

Run by

Cyberonics, Inc.

People needed

20

Starts

2013-07-01

Expected to finish

2015-08-01

Last updated by the study team

2015-11-24

Who can join

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

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.

Where it is running

• Study site — Phoenix, Arizona, United States
• Study site — Stanford, California, United States
• Study site — Tampa, Florida, United States
• Study site — Atlanta, Georgia, United States
• Study site — Chicago, Illinois, United States
• Study site — Ann Arbor, Michigan, United States
• Study site — Saint Paul, Minnesota, United States
• Study site — Kansas City, Missouri, United States
• Study site — Albany, New York, United States
• Study site — Durham, North Carolina, United States
• Study site — Pittsburgh, Pennsylvania, United States
• Study site — Memphis, Tennessee, United States
• Study site — Dallas, Texas, United States
• Study site — Houston, Texas, United States
• Study site — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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