Clinical trial NCT01485016: Physiological and Biomechanical Data Collection Study in Epilepsy Subjects
Official title: Observational Study Collecting Physiological and Biomechanical Data in Ambulatory Subjects With Epilepsy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Epilepsy
Keywords: epilepsy
ECG
accelerometer
Lead sponsor: Cyberonics, Inc.
Sponsor class: INDUSTRY
First posted: 2011-12-05
Enrollment: 20
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult and pediatric epilepsy patients willing to provide physiological and biomechanical data

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.

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.

Primary outcomes:
measure: To gather changes in physiological and biomechanical data in epilepsy subjects
timeFrame: 72 hours
Secondary outcomes:
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: Clinical Trials of Texas, Inc.
state: Texas
Study officials:
affiliation: Clinical Trials of Texas, Inc.
name: Douglas Denham, DO
role: PRINCIPAL_INVESTIGATOR
affiliation: Cyberonics, Inc.
name: Bryan Olin, Ph.D
role: STUDY_DIRECTOR
References: