EpilepsyNCT01214707
Heart Rate Changes During Normal Activity, Exercise, and Seizures in Subjects With Epilepsy
An observational study of Epilepsy, run by Cyberonics, Inc. at 2 sites in United States.
Trial summary
Characterization of the cardiac response (ECG) preceding an epileptic seizure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Epilepsy
- What is being tested?
- Exercise
- How many people
- 30 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 2010to Oct 2011
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults with epilepsy already scheduled for an EMU stay.
Who may be able to join
- Patient has a clinical diagnosis of epilepsy requiring additional evaluation in an epilepsy monitoring unit (EMU).
- Patient likely requires an EMU evaluation for a period of at least 3 days.
- In the opinion of the Principal Investigator, the Patient is likely to have 3 - 5 seizures during the EMU stay.
- Patient is currently taking at least one antiepileptic medication.
- Patients must be 18 years or older and may be of either sex and of any race.
- Patient must be in good general health, fully ambulatory, and able to complete the physical aspects of testing requirements.
- Patient must be willing and able to complete informed consent and HIPAA authorization.
- Patient is diagnosed with epilepsy but may also experience pseudo seizures or psychogenic seizures.
Who cannot join
- Patients with severe psychiatric disease that in the investigator's judgment would prevent the patient's successful completion of the study.
- Patients experiencing status epileptic within the last 6 months.
- Patients with cardiovascular, respiratory, neuromuscular or gait disorders that in the investigator's judgment would cause unnecessary risk.
- Patients prescribed drugs specifically for a cardiac or autonomic disorder that in the investigator's opinion would affect heart rate response. Drugs with secondary cardiac or autonomic actions are allowed.
- Patients with cardiovascular arrhythmias or cardiac disease that would preclude the ability to detect intrinsic changes in heart rate due to exercise, stress, or seizure. This would include but not be limited to chronic atrial fibrillation and permanent cardiac pacemaker implantation.
- Patients currently dependent on alcohol or narcotic drugs as defined by DSM IV-R.
- Patients with a history of only psychogenic seizures or pseudo seizures.
- Women who are pregnant. Women of childbearing age must take a pregnancy test.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
KUMC
Kansas City, Kansas, 66160
BNI
Phoenix, Arizona, 85013
About this study
Characterization of the cardiac response (ECG) preceding an epileptic seizure.
Read the detailed description
Characterization of the cardiac response (ECG) to physiologic events and comparison to changes in heart rate that precede an epileptic seizure.
- Conditions
- Epilepsy
- Being tested
- Exercise
- Keywords
- Exercise/No active Treatment
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
Also called Exercise during EMU stay. No treatment intervention.
Exercise during EMU stay
| Study group | Role | What they receive |
|---|---|---|
| Exercise protocol | No arms are required for this study as all subjects complete the entire protocol Receives: Other: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart Rate Changes during Normal Activity, Exercise, and Seizures in Subjects with Epilepsy
Characterization of the cardiac response (ECG) to physiologic events and comparison to changes in heart rate that precede an epileptic seizure.
Measured: 3 to 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2010 (estimated)
- Study startSep 2010
- Primary completionOct 2011
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
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cyberonics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David M Treiman, MD, Principal investigator, Barrow Neurological Institute Phoenix AZIvan Osorio, MD, Principal investigator, KUMC Kansas City, Kansas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01214707
- Sponsor's protocol ID
- E-31
- Status last verified
- Mar 2012
- First submitted
- 1 Oct 2010
- Last updated
- 15 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Heart Rate Changes During Normal Activity, Exercise, and Seizures in Subjects With Epilepsy
- ClinicalTrials.gov ID
- NCT01214707
- Acronym / sponsor ID
- E-31
- Conditions
- Epilepsy
- Keywords
- Exercise/No active Treatment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Cyberonics, Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2010
- Primary completion
- Oct 2011 (actual)
- First posted
- 5 Oct 2010 (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.
Characterization of the cardiac response (ECG) preceding an epileptic seizure.
Detailed description
Characterization of the cardiac response (ECG) to physiologic events and comparison to changes in heart rate that precede an epileptic seizure.
Study design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Exercise protocol | – | Other: ExerciseNo arms are required for this study as all subjects complete the entire protocol |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults with epilepsy already scheduled for an EMU stay.
Key inclusion criteria (8 listed)
- Patient has a clinical diagnosis of epilepsy requiring additional evaluation in an epilepsy monitoring unit (EMU).
- Patient likely requires an EMU evaluation for a period of at least 3 days.
- In the opinion of the Principal Investigator, the Patient is likely to have 3 - 5 seizures during the EMU stay.
- Patient is currently taking at least one antiepileptic medication.
- Patients must be 18 years or older and may be of either sex and of any race.
Key exclusion criteria (8 listed)
- Patients with severe psychiatric disease that in the investigator's judgment would prevent the patient's successful completion of the study.
- Patients experiencing status epileptic within the last 6 months.
- Patients with cardiovascular, respiratory, neuromuscular or gait disorders that in the investigator's judgment would cause unnecessary risk.
- Patients prescribed drugs specifically for a cardiac or autonomic disorder that in the investigator's opinion would affect heart rate response. Drugs with secondary cardiac or autonomic actions are allowed.
- Patients with cardiovascular arrhythmias or cardiac disease that would preclude the ability to detect intrinsic changes in heart rate due to exercise, stress, or seizure. This would include but not be limited to chronic atrial fibrillation and permanent cardiac pacemaker implantation.
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 |
|---|---|---|
| ExerciseAlso: Exercise during EMU stay. No treatment intervention.Exercise during EMU stay | Other | Exercise protocol |
Primary outcome
Heart Rate Changes during Normal Activity, Exercise, and Seizures in Subjects with Epilepsy
Time frame: 3 to 5 days
Characterization of the cardiac response (ECG) to physiologic events and comparison to changes in heart rate that precede an epileptic seizure.
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 15 Mar 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.
David M Treiman, MD principal investigator
Barrow Neurological Institute Phoenix AZ
Ivan Osorio, MD principal investigator
KUMC Kansas City, Kansas
2 sites 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 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 8 inclusion and 8 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 15 Mar 2012. 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?
Heart Rate Changes during Normal Activity, Exercise, and Seizures in Subjects with Epilepsy (time frame: 3 to 5 days). 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 15 Mar 2012.