EpilepsyNCT01612689
3-Dimensional Accelerometer Sub-Study
A study testing Accelerometer Device in people with Epilepsy, run by Cyberonics, Inc. at 2 sites in United States.
Trial summary
This is a prospective, unblinded sub-study to the E-30 to gather physiological data. Read more about this study
- Who is it for?
- Ages 6 years and older
- Conditions the study is for
- Epilepsy
- What is being tested?
- Accelerometer Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 2 sitesUnited States
- Study dates
- May 2012to Jul 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- (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
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- (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
Who cannot join
- (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.
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- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Study site
Chicago, Illinois, 60637
Study site
Gainesville, Florida, 32610
About this study
Official title: 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.
Read the 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.
- Conditions
- Epilepsy
- Being tested
- Accelerometer Device
- Keywords
- Accelerometer, EMU, Ambulatory, ECG, Heart rate
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Accelerometer DeviceDevice
A sensor platform that enables physiological monitoring in routine, home or office environments.
| Study group | Role | What they receive |
|---|---|---|
| Physiologic Data Collection | Experimental | Not described Receives: Device: Accelerometer Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Up to 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2012 (estimated)
- Study startMay 2012
- Primary completionOct 2012
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cyberonics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bryan Olin, Study director, Cyberonics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01612689
- Sponsor's protocol ID
- E-30-S
- Status last verified
- Aug 2014
- First submitted
- 4 Jun 2012
- Last updated
- 7 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT01612689
- Acronym / sponsor ID
- E-30-S
- Conditions
- Epilepsy
- Keywords
- Accelerometer, EMU, Ambulatory, ECG, Heart rate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Cyberonics, Inc.Industry (pharma, biotech, devices)
- Study start
- May 2012
- Primary completion
- Oct 2012 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 6 Jun 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a prospective, unblinded sub-study to the E-30 to gather physiological data.
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 design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Physiologic Data Collection | Experimental | Device: Accelerometer Device |
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- (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
Key exclusion criteria (15 listed)
- (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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Accelerometer DeviceA sensor platform that enables physiological monitoring in routine, home or office environments. | Device | Physiologic Data Collection |
Primary outcome
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bryan Olin study director
Cyberonics, Inc.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Accelerometer Device in people with Epilepsy, run by Cyberonics, Inc. at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gather physiological data (time frame: Up to 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2014.