3-Dimensional Accelerometer Sub-Study

NCT01612689 | Completed

• 1 other identifier: E-30-S
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 2

Brief Summary

This is a prospective, unblinded sub-study to the E-30 to gather physiological data.

Conditions

Epilepsy

Keywords

Accelerometer; EMU; Ambulatory; ECG; Heart rate

Outcome Measures

Primary Outcomes (1)

• Gather physiological data

  The purpose of this sub-study is to gather physiological data in consenting subjects who were previously enrolled in the "parent" E-30 study (NCT01202669).

  Up to 2 weeks

Study Arms (1)

Physiologic Data Collection

EXPERIMENTAL

Device: Accelerometer Device

Interventions

Accelerometer Device DEVICE

A sensor platform that enables physiological monitoring in routine, home or office environments.

Physiologic Data Collection

Eligibility Criteria

• Age: 6 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• (Phase 1)
• Subject be scheduled to participated in the E-30 parent study for a minimum of 48 hours
• Subject has a clinical diagnosis of epilepsy based on a prior EMU visit
• (Phase 1\&2)
• Subject is currently enrolled or previously participated in the E-30 study
• Subject must be 6 years of age or older
• (Sleep State: Optional)
• Subject must be 12 years of age
• Subject is currently enrolled in the E-30S sub-study and is willing to stay in a light controlled environment in the EMU for up to 120 hours

You may not qualify if:

• (Phase 1\&2)
• Subjects with a medical condition that in the opinion of the investigator would affect his/her ability to participate in the sub-study.
• Subject who has implanted defibrillator, pacemaker or Vagus Nerve Stimulation Therapy® (VNS) System
• 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 sub-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.
• (Sleep State: Optional)
• Subjects with a history if gastrointestinal disease (GI)or GI surgery
• Subjects with a history of difficulty swallowing
• Subjects with diabetes mellitus
• Subjects with uncontrolled hypertension
• Subjects with planned MRI during EMU stay

Sponsors & Collaborators

• Cyberonics, Inc.: lead

Study Sites (2)

Unknown Facility

Gainesville, Florida, 32610, United States

Location

Unknown Facility

Chicago, Illinois, 60637, United States

Location

MeSH Terms

Conditions

Epilepsy

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Bryan Olin

  Cyberonics, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2012
• First Posted: June 6, 2012
• Study Start: May 1, 2012
• Primary Completion: October 1, 2012
• Study Completion: July 1, 2014
• Last Updated: August 7, 2014

Record last verified: 2014-08

Locations

US (2)