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Physiological and Biomechanical Data Collection Study in Epilepsy Subjects

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Cyberonics, Inc.
ClinicalTrials.gov Identifier:
NCT01485016
First received: November 21, 2011
Last updated: August 20, 2012
Last verified: August 2012
  Purpose

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


Condition
Epilepsy

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Observational Study Collecting Physiological and Biomechanical Data in Ambulatory Subjects With Epilepsy

Resource links provided by NLM:


Further study details as provided by Cyberonics, Inc.:

Primary Outcome Measures:
  • To gather changes in physiological and biomechanical data in epilepsy subjects [ Time Frame: 72 hours ] [ Designated as safety issue: No ]
    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.


Enrollment: 20
Study Start Date: November 2011
Study Completion Date: July 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
ambulatory epilepsy subjects

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.

  Eligibility

Ages Eligible for Study:   6 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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:

  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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01485016

Locations
United States, Texas
Clinical Trials of Texas, Inc.
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
Cyberonics, Inc.
Investigators
Principal Investigator: Douglas Denham, DO Clinical Trials of Texas, Inc.
Study Director: Bryan Olin, Ph.D Cyberonics, Inc.
  More Information

No publications provided

Responsible Party: Cyberonics, Inc.
ClinicalTrials.gov Identifier: NCT01485016     History of Changes
Other Study ID Numbers: E-32
Study First Received: November 21, 2011
Last Updated: August 20, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Cyberonics, Inc.:
epilepsy
ECG
accelerometer

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

ClinicalTrials.gov processed this record on November 25, 2014