- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01612689
3-Dimensional Accelerometer Sub-Study
August 6, 2014 updated by: Cyberonics, Inc.
3-Dimensional Accelerometer Sub-Study for Patients Participating in the E-30 Study: Heart Rate Changes in Subjects With Epilepsy During an Epilepsy Monitoring Unit Admission
This is a prospective, unblinded sub-study to the E-30 to gather physiological data.
Study Overview
Detailed Description
This sub-study to the E-30 is designed to collect vital signs, accelerometer and ECG data on subjects, and will consist of two phases.
Phase 1 is designed to collect data in an Epilepsy Monitoring Unit (EMU) and Phase 2 is designed to collect data in an everyday (ambulatory) setting.
Study Type
Interventional
Enrollment (Actual)
16
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Florida
-
Gainesville, Florida, United States, 32610
-
-
Illinois
-
Chicago, Illinois, United States, 60637
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
6 years and older (ADULT, OLDER_ADULT, CHILD)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
(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
Exclusion Criteria:
(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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Physiologic Data Collection
|
A sensor platform that enables physiological monitoring in routine, home or office environments.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Gather physiological data
Time Frame: Up to 2 weeks
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2012
Primary Completion (ACTUAL)
October 1, 2012
Study Completion (ACTUAL)
July 1, 2014
Study Registration Dates
First Submitted
June 4, 2012
First Submitted That Met QC Criteria
June 5, 2012
First Posted (ESTIMATE)
June 6, 2012
Study Record Updates
Last Update Posted (ESTIMATE)
August 7, 2014
Last Update Submitted That Met QC Criteria
August 6, 2014
Last Verified
August 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- E-30-S
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Epilepsy
-
NaviFUS CorporationTaipei Veterans General Hospital, TaiwanCompletedDrug Resistant Epilepsy | Epilepsy, Drug Resistant | Intractable Epilepsy | Refractory Epilepsy | Drug Refractory Epilepsy | Epilepsy, Drug Refractory | Epilepsy, Intractable | Medication Resistant EpilepsyTaiwan
-
Great Ormond Street Hospital for Children NHS Foundation...Active, not recruitingEpilepsies, Partial | Intractable Epilepsy | Focal Epilepsy | Refractory Epilepsy | Epilepsy Intractable | Epilepsy in Children | Epilepsy, FocalUnited Kingdom
-
University of British ColumbiaTerminatedJuvenile Myoclonic Epilepsy | Childhood Absence Epilepsy | Juvenile Absence EpilepsyCanada
-
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityRecruiting
-
Neuroelectrics CorporationRecruitingEpilepsy | Seizures | Refractory Epilepsy | Epilepsy, Tonic-Clonic | Epilepsy in Children | Seizures, Focal | Focal SeizureSpain, United States, France, Belgium
-
Oslo University HospitalCompletedEpilepsy | Generalized Epilepsy | Focal EpilepsyNorway
-
University Hospital, LilleUnknownFocal Epilepsy | Epilepsy IntractableFrance
-
UCB Pharma SACompletedEpilepsy, Tonic-clonicPoland, Sweden, Hungary, Czechia
-
UCB PharmaCompletedEpilepsy, Tonic-clonic
-
Xuanwu Hospital, BeijingPeking University; Beijing Tiantan Hospital; Qilu Hospital of Shandong University and other collaboratorsRecruitingEpilepsy, Drug ResistantChina
Clinical Trials on Accelerometer Device
-
BioGaia ABAtlantia Food Clinical Trials; ActivInsightsRecruiting
-
Institut de Myologie, FranceCompleted
-
Institut de Myologie, FranceCompleted
-
University Hospital, GrenobleCompletedStress Urinary IncontinenceFrance
-
KU LeuvenUniversitaire Ziekenhuizen KU Leuven; Research Foundation FlandersCompleted
-
Centre Hospitalier Universitaire de Saint EtienneRecruitingFrailty | Fall PatientsFrance
-
University of East AngliaUnknown
-
University Hospital, LimogesRecruiting
-
PepsiCo Global R&DCompletedSleep Quantity | Sleep EfficiencyUnited States
-
Swansea UniversityCompleted