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CompletedNCT01485016Updated Aug 21, 2012

Physiological and Biomechanical Data Collection Study in Epilepsy Subjects

An observational study in Epilepsy, sponsored by Cyberonics, Inc.. Completed at 1 site in United States. Open to participants aged 6 Years and older. Per ClinicalTrials.gov, last updated 2012-08-21.

Sponsored by Cyberonics, Inc. · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
20
Ages
6 Years and older
Sex
All
01

Study summary

The purpose of this study is to gather changes in physiological and biomechanical data during daily activity and sleep in epilepsy subjects.

Read the detailed description

The purpose of this study is to gather changes in physiological and biomechanical data such as ECG, respiration, and accelerometry data during daily activity and sleep in pediatric and adult subjects with epilepsy. Subjects will use a device that enables monitoring of the human state in everyday, free-living environments.

02

Conditions studied

  • Epilepsy

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Keywords

  • epilepsy
  • ECG
  • accelerometer
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 20 is below the median of 102 across 521 observational 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
Sampling method
Non-probability sample

Study population

Adult and pediatric epilepsy patients willing to provide physiological and biomechanical data

Inclusion criteria

  1. Subject must be six (6) years of age or older
  2. Subject has a clinical diagnosis of epilepsy
  3. Subject is currently taking at least one antiepileptic medication.
  4. Subject must be in good general health and fully ambulatory.
  5. Subject or guardian must be willing and able to complete informed consent and/or assent for children and HIPAA authorization.

Exclusion criteria

Exclusion Criteria:

  1. Subjects with chest circumference smaller than 29 inches or greater than 47 inches.
  2. Subjects with existing signs of skin irritation, rash, damage or infection on the torso that in the opinion of the investigator would prevent the subject's participation in the study.
  3. Subjects with a medical condition that in the opinion of the investigator would affect his/her ability to participate in the study.
  4. Subjects with implanted defibrillators, pacemakers or neurostimulators (e.g., vagus nerve stimulators or pain stimulators).
  5. Subjects who are pregnant or lactating.
  6. Subjects with severe psychiatric disease that in the opinion of the investigator would prevent the subject's successful completion of the study.
  7. Subjects 6 to 16 years of age with moderate/severe learning difficulties or those who may be at risk of self-harm.
  8. 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").
  9. 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.
  10. Subjects with a history of dependence on alcohol or narcotic drugs within the past 2 years as defined by DSM IV-R.
  11. Subjects currently participating in another clinical study.
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
20 participants (actual)

Groups and cohorts

  • ambulatory epilepsy subjects
06

What researchers measure

Primary outcomes

  1. To gather changes in physiological and biomechanical data in epilepsy subjects

    The E-32 study was designed to capture the subject's physiological and biomechanical data such as ECG data and rate, respiratory data and rate, and body orientation, motion and movement (accelerometry) during typical events such as walking, sitting, running and sleeping in order to help build a database of stereotypical human activity.

    Time frame: 72 hours

07

Study locations

1 site
  • Clinical Trials of Texas, Inc.
    San Antonio, Texas 78229, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 21, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01485016
Lead sponsor
Cyberonics, Inc.
Responsible party
Sponsor
First posted
Dec 5, 2011
Start date
Nov 2011
Primary completion
May 2012
Completion
Jul 2012
Last update
Aug 21, 2012

Study contacts

Douglas Denham, DO
principal investigator · Clinical Trials of Texas, Inc.
Bryan Olin, Ph.D
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 2012. You cannot join it, but the record below documents what was studied.

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