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3-Dimensional Accelerometer Sub-Study

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Cyberonics, Inc.
ClinicalTrials.gov Identifier:
NCT01612689
First received: June 4, 2012
Last updated: February 15, 2013
Last verified: January 2013
History of Changes
  Purpose

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


Condition Intervention
Epilepsy
 Device: Accelerometer Device

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: Epilepsy
U.S. FDA Resources

Further study details as provided by Cyberonics, Inc.:

Primary Outcome Measures:
  • Gather physiological data [ Time Frame: Up to 2 weeks ] [ Designated as safety issue: No ]
    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).


Estimated Enrollment: 500
Study Start Date: May 2012
Estimated Study Completion Date: April 2013
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Physiologic Data Collection Device: Accelerometer Device
A sensor platform that enables physiological monitoring in routine, home or office environments.

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.

  Eligibility

Ages Eligible for Study:   6 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01612689

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

No publications provided

Responsible Party: Cyberonics, Inc.
ClinicalTrials.gov Identifier: NCT01612689     History of Changes
Other Study ID Numbers: E-30-S
Study First Received: June 4, 2012
Last Updated: February 15, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Cyberonics, Inc.:
Accelerometer
EMU
Ambulatory
ECG
Heart rate

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

ClinicalTrials.gov processed this record on June 18, 2013