Physiological and Biomechanical Data Collection Study in Epilepsy Subjects

Epilepsy Clinical Trial

Official title:

Observational Study Collecting Physiological and Biomechanical Data in Ambulatory Subjects With Epilepsy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01485016
• Other study ID #: E-32
• Status: Completed
• Phase: N/A
• First received: November 21, 2011
• Last updated: August 20, 2012
• Start date: November 2011
• Est. completion date: July 2012

Study information

• Verified date: August 2012
• Source: Cyberonics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: July 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years and older

Eligibility

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.

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Epilepsy

Locations

Country	Name	City	State
United States	Clinical Trials of Texas, Inc.	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Cyberonics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To gather changes in physiological and biomechanical data in epilepsy subjects	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.	72 hours	No