EpilepsyNCT01485016
Physiological and Biomechanical Data Collection Study in Epilepsy Subjects
An observational study of Epilepsy, run by Cyberonics, Inc. at 1 site in United States.
Trial summary
The purpose of this study is to gather changes in physiological and biomechanical data during daily activity and sleep in epilepsy subjects. Read more about this study
- Who is it for?
- Ages 6 years and older
- Conditions the study is for
- Epilepsy
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2011to Jul 2012
- Phase
- Observational
- 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
Study population: Adult and pediatric epilepsy patients willing to provide physiological and biomechanical data
Who may be able to join
- Subject must be six (6) years of age or older
- Subject has a clinical diagnosis of epilepsy
- Subject is currently taking at least one antiepileptic medication.
- Subject must be in good general health and fully ambulatory.
- Subject or guardian must be willing and able to complete informed consent and/or assent for children and HIPAA authorization.
Who cannot join
- Subjects with chest circumference smaller than 29 inches or greater than 47 inches.
- 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.
- Subjects with a medical condition that in the opinion of the investigator would affect his/her ability to participate in the study.
- Subjects with implanted defibrillators, pacemakers or neurostimulators (e.g., vagus nerve stimulators or pain stimulators).
- 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 study.
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- 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.
- Subjects currently participating in another clinical study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Clinical Trials of Texas, Inc.
San Antonio, Texas, 78229
About this study
Official title: Observational Study Collecting Physiological and Biomechanical Data in Ambulatory Subjects With Epilepsy
The purpose of this study is to gather changes in physiological and biomechanical data during daily activity and sleep in epilepsy subjects.
Read the 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.
- Conditions
- Epilepsy
- Keywords
- epilepsy, ECG, accelerometer
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| ambulatory epilepsy subjects | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2011 (estimated)
- Study startNov 2011
- Primary completionMay 2012
- Study completionJul 2012
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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cyberonics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Douglas Denham, DO, Principal investigator, Clinical Trials of Texas, Inc.Bryan Olin, Ph.D, Study director, Cyberonics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01485016
- Sponsor's protocol ID
- E-32
- Status last verified
- Aug 2012
- First submitted
- 21 Nov 2011
- Last updated
- 21 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study Collecting Physiological and Biomechanical Data in Ambulatory Subjects With Epilepsy
- ClinicalTrials.gov ID
- NCT01485016
- Acronym / sponsor ID
- E-32
- Conditions
- Epilepsy
- Keywords
- epilepsy, ECG, accelerometer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Cyberonics, Inc.Industry (pharma, biotech, devices)
- Study start
- Nov 2011
- Primary completion
- May 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 5 Dec 2011 (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.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ambulatory epilepsy subjects | – | – |
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Adult and pediatric epilepsy patients willing to provide physiological and biomechanical data
Key inclusion criteria (5 listed)
- Subject must be six (6) years of age or older
- Subject has a clinical diagnosis of epilepsy
- Subject is currently taking at least one antiepileptic medication.
- Subject must be in good general health and fully ambulatory.
- Subject or guardian must be willing and able to complete informed consent and/or assent for children and HIPAA authorization.
Key exclusion criteria (11 listed)
- Subjects with chest circumference smaller than 29 inches or greater than 47 inches.
- 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.
- Subjects with a medical condition that in the opinion of the investigator would affect his/her ability to participate in the study.
- Subjects with implanted defibrillators, pacemakers or neurostimulators (e.g., vagus nerve stimulators or pain stimulators).
- Subjects who are pregnant or lactating.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To gather changes in physiological and biomechanical data in epilepsy subjects
Time frame: 72 hours
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.
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 21 Aug 2012.
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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.
Douglas Denham, DO principal investigator
Clinical Trials of Texas, Inc.
Bryan Olin, Ph.D study director
Cyberonics, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Epilepsy, run by Cyberonics, Inc. at 1 site 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 5 inclusion and 11 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 21 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
To gather changes in physiological and biomechanical data in epilepsy subjects (time frame: 72 hours). 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 21 Aug 2012.