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CompletedNCT01612689Updated Aug 7, 2014

3-Dimensional Accelerometer Sub-Study

An interventional study of Accelerometer Device in Epilepsy, sponsored by Cyberonics, Inc.. Completed at 2 sites in United States. Open to participants aged 6 Years and older. Per ClinicalTrials.gov, last updated 2014-08-07.

Sponsored by Cyberonics, Inc. · Not applicable and Interventional

Phase
Not applicable
Study type
Interventional
Enrollment
16
Allocation
Not applicable
Ages
6 Years and older
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Epilepsy

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Keywords

  • Accelerometer
  • EMU
  • Ambulatory
  • ECG
  • Heart rate
03

In context

Epilepsy

1,805 studies on the registry are indexed under Epilepsy; 417 are open to participants now.

This study's enrollment of 16 is below the median of 50 across 1,206 interventional studies indexed under Epilepsy.

Browse Epilepsy studies →

Lead sponsor

Cyberonics, Inc. is the lead sponsor of 22 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Years and older
Sexes eligible
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

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
05

Study design

Phase
Not applicable
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
16 participants (actual)

Study arms

  • Experimental
    Physiologic Data Collection

    Device: Accelerometer Device

Interventions

  • DeviceAccelerometer Device

    A sensor platform that enables physiological monitoring in routine, home or office environments.

06

What researchers measure

Primary outcomes

  1. Gather physiological data

    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).

    Time frame: Up to 2 weeks

07

Study locations

2 sites
  • Gainesville, Florida 32610, United States
  • Chicago, Illinois 60637, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 7, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01612689
Lead sponsor
Cyberonics, Inc.
Responsible party
Sponsor
First posted
Jun 6, 2012
Start date
May 2012
Primary completion
Oct 2012
Completion
Jul 2014
Last update
Aug 7, 2014

Study contacts

Bryan Olin
study director · Cyberonics, Inc.

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2014. You cannot join it, but the record below documents what was studied.

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Discussion

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