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Physiological and Biomechanical Data Collection Study in Epilepsy Subjects

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.
 
ClinicalTrials.gov Identifier: NCT01485016
Recruitment Status : Completed
First Posted : December 5, 2011
Last Update Posted : August 21, 2012
Sponsor:
Information provided by (Responsible Party):
Cyberonics, Inc.

Tracking Information
First Submitted Date November 21, 2011
First Posted Date December 5, 2011
Last Update Posted Date August 21, 2012
Study Start Date November 2011
Actual Primary Completion Date May 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 1, 2011)
To gather changes in physiological and biomechanical data in epilepsy subjects [ Time Frame: 72 hours ]
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.
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT01485016 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Physiological and Biomechanical Data Collection Study in Epilepsy Subjects
Official Title Observational Study Collecting Physiological and Biomechanical Data in Ambulatory Subjects With Epilepsy
Brief Summary The purpose of this study is to gather changes in physiological and biomechanical data during daily activity and sleep in 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.
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Adult and pediatric epilepsy patients willing to provide physiological and biomechanical data
Condition Epilepsy
Intervention Not Provided
Study Groups/Cohorts ambulatory epilepsy subjects
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: December 1, 2011)
20
Original Estimated Enrollment Same as current
Actual Study Completion Date July 2012
Actual Primary Completion Date May 2012   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 6 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01485016
Other Study ID Numbers E-32
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Cyberonics, Inc.
Study Sponsor Cyberonics, Inc.
Collaborators Not Provided
Investigators
Principal Investigator: Douglas Denham, DO Clinical Trials of Texas, Inc.
Study Director: Bryan Olin, Ph.D Cyberonics, Inc.
PRS Account Cyberonics, Inc.
Verification Date August 2012