CompletedNot Applicable

Physiological and Biomechanical Data Collection Study in Epilepsy Subjects

United States20 participantsStarted 2011-11

Plain-language summary

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

Age range6 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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.

✕. 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").

To gather changes in physiological and biomechanical data in epilepsy subjects

Timeframe: 72 hours

NCT IDNCT01485016

SponsorCyberonics, Inc.

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2012-05

Who can participate

Age range6 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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.

✕. 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").