3-Dimensional Accelerometer Sub-Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01612689
Recruitment Status : Completed
First Posted : June 6, 2012
Last Update Posted : August 7, 2014
Information provided by (Responsible Party):
Cyberonics, Inc.

Brief Summary:
This is a prospective, unblinded sub-study to the E-30 to gather physiological data.

Condition or disease Intervention/treatment Phase
Epilepsy Device: Accelerometer Device Not Applicable

Detailed Description:
This sub-study to the E-30 is designed to collect vital signs, accelerometer and ECG data on subjects, and will consist of two phases. Phase 1 is designed to collect data in an Epilepsy Monitoring Unit (EMU) and Phase 2 is designed to collect data in an everyday (ambulatory) setting.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: 3-Dimensional Accelerometer Sub-Study for Patients Participating in the E-30 Study: Heart Rate Changes in Subjects With Epilepsy During an Epilepsy Monitoring Unit Admission
Study Start Date : May 2012
Actual Primary Completion Date : October 2012
Actual Study Completion Date : July 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Epilepsy
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Physiologic Data Collection Device: Accelerometer Device
A sensor platform that enables physiological monitoring in routine, home or office environments.

Primary Outcome Measures :
  1. Gather physiological data [ Time Frame: Up to 2 weeks ]
    The purpose of this sub-study is to gather physiological data in consenting subjects who were previously enrolled in the "parent" E-30 study (NCT01202669).

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

(Phase 1)

  • Subject be scheduled to participated in the E-30 parent study for a minimum of 48 hours
  • Subject has a clinical diagnosis of epilepsy based on a prior EMU visit

(Phase 1&2)

  • Subject is currently enrolled or previously participated in the E-30 study
  • Subject must be 6 years of age or older

(Sleep State: Optional)

  • Subject must be 12 years of age
  • Subject is currently enrolled in the E-30S sub-study and is willing to stay in a light controlled environment in the EMU for up to 120 hours

Exclusion Criteria:

(Phase 1&2)

  • Subjects with a medical condition that in the opinion of the investigator would affect his/her ability to participate in the sub-study.
  • Subject who has implanted defibrillator, pacemaker or Vagus Nerve Stimulation Therapy® (VNS) System
  • Subjects who are pregnant or lactating
  • Subjects with severe psychiatric disease that in the opinion of the investigator would prevent the subject's successful completion of the sub-study.
  • Subjects 6 to 16 years of age with moderate/severe learning difficulties or those who may be at risk of self-harm.
  • Subjects prescribed drugs specifically for a cardiac or autonomic disorder that in the investigator's opinion would affect heart rate response unless the patient has ictal tachycardia while taking said drugs. These include, but are not limited to, beta adrenergic antagonists ("beta blockers").
  • Subjects with cardiovascular arrhythmias or cardiac disease that would preclude the ability to detect intrinsic changes in heart rate due to activity, stress, or seizure. This would include but not be limited to chronic atrial fibrillation or chronotropic incompetence.
  • Subjects with a history of dependence on alcohol or narcotic drugs within the past 2 years as defined by DSM IV-R.

(Sleep State: Optional)

  • Subjects with a history if gastrointestinal disease (GI)or GI surgery
  • Subjects with a history of difficulty swallowing
  • Subjects with diabetes mellitus
  • Subjects with uncontrolled hypertension
  • Subjects with planned MRI during EMU stay

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01612689

United States, Florida
Gainesville, Florida, United States, 32610
United States, Illinois
Chicago, Illinois, United States, 60637
Sponsors and Collaborators
Cyberonics, Inc.
Study Director: Bryan Olin Cyberonics, Inc.

Responsible Party: Cyberonics, Inc. Identifier: NCT01612689     History of Changes
Other Study ID Numbers: E-30-S
First Posted: June 6, 2012    Key Record Dates
Last Update Posted: August 7, 2014
Last Verified: August 2014

Keywords provided by Cyberonics, Inc.:
Heart rate

Additional relevant MeSH terms:
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases