Status:
COMPLETED
Physiological and Biomechanical Data Collection Study in Epilepsy Subjects
Lead Sponsor:
Cyberonics, Inc.
Conditions:
Epilepsy
Eligibility:
All Genders
6+ years
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 ...
Eligibility Criteria
Inclusion
- Subject must be six (6) years of age or older
- Subject has a clinical diagnosis of epilepsy
- Subject is currently taking at least one antiepileptic medication.
- Subject must be in good general health and fully ambulatory.
- Subject or guardian must be willing and able to complete informed consent and/or assent for children and HIPAA authorization.
Exclusion
- Subjects with chest circumference smaller than 29 inches or greater than 47 inches.
- 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.
- Subjects with a medical condition that in the opinion of the investigator would affect his/her ability to participate in the study.
- Subjects with implanted defibrillators, pacemakers or neurostimulators (e.g., vagus nerve stimulators or pain stimulators).
- 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 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.
- Subjects currently participating in another clinical study.
Key Trial Info
Start Date :
November 1 2011
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 1 2012
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT01485016
Start Date
November 1 2011
End Date
July 1 2012
Last Update
August 21 2012
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Clinical Trials of Texas, Inc.
San Antonio, Texas, United States, 78229