Physiological and Biomechanical Data Collection Study in Epilepsy Subjects

Completed

Conditions studied: Epilepsy

In brief

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

Key facts

Study ID

NCT01485016

Run by

Cyberonics, Inc.

People needed

20

Starts

2011-11-01

Expected to finish

2012-07-01

Last updated by the study team

2012-08-21

Who can join

Age: 6 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Clinical Trials of Texas, Inc. — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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