Refractory EpilepsyNCT00203333
Cardiac Rhythm Abnormalities in Patients With Refractory Epilepsy at High Risk for Sudden Death
An observational study of Refractory Epilepsy and Arrhythmia, run by Thomas Jefferson University at 1 site in United States.
Trial summary
People with epilepsy are at a higher risk for sudden unexpected death than the general population. Sudden unexpected death in epilepsy (SUDEP) is a major cause of death in this population, accounting for 10-50% of deaths for those with epilepsy. Read more about this study
- Who is it for?
- Ages 16 to 49 years
- Conditions the study is for
- Refractory Epilepsy, Arrhythmia, Sudden Death
- What is being tested?
- Medtronic REVEAL
- Type of treatment
- Medical device
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2002to Jan 2010
- 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 16 to 49 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Individuals with refractory focal or generalized epilepsy.
Who may be able to join
- Refractory epilepsy
Who cannot join
- Other pre-existing heart conditions
Trial locations and contacts
1 site in 1 country.
United States1 site
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
About this study
People with epilepsy are at a higher risk for sudden unexpected death than the general population. Sudden unexpected death in epilepsy (SUDEP) is a major cause of death in this population, accounting for 10-50% of deaths for those with epilepsy. The risk for SUDEP is particularly high for those with refractory epilepsy. Several lines of evidence support a cardiac mechanism for SUDEP.
This study plans to determine:
Read more
- the frequency and types of cardiac arrhythmias that occur in this population and
- whether these are increased above the general population in the same age group.
Additionally, these data will be correlated to specific clinical data, including seizure history, anticonvulsant medications, and any accompanying clinical symptoms.
Read the detailed description
By employing long-term electrocardiographic monitoring, this study plans to determine:
- the frequency and types of cardiac arrhythmias that occur in patients with uncontrolled seizures and
- whether these are increased above the general population in the same age group.
The specific aims:
- Identify the types, frequency, and duration of cardiac arrhythmias that occur in patients with refractory epilepsy and compare these data to available normative data.
- Correlate abnormal heart rates and rhythms to specific clinical data:
- seizure type,
- seizure frequency,
- probable location of seizure onset in the brain, when such data are available,
- duration of seizures, and
- type(s) and number of anticonvulsant medications being used.
- Correlate cardiac arrhythmias to clinical symptoms
- Conditions
- Refractory Epilepsy, Arrhythmia, Sudden Death
- Being tested
- Medtronic REVEAL
- Keywords
- Epilepsy
- Medical subject headings
- Drug Resistant Epilepsy, Arrhythmias, Cardiac, Death, Sudden, Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medtronic REVEALDevice
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startApr 2002
- Primary completionJun 2007
- Study completionJan 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Refractory EpilepsyStudies of the same condition, open and under way.
- More trials run by Thomas Jefferson UniversityThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thomas Jefferson University
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic
- Responsible party
- Sponsor
- Investigators
- Maromi Nei, MD, Principal investigator, Thomas Jefferson University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00203333
- Sponsor's protocol ID
- J05901
- Status last verified
- Oct 2016
- First submitted
- 13 Sep 2005
- Last updated
- 18 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Nei M, Sperling MR, Mintzer S, Ho RT. Long-term cardiac rhythm and repolarization abnormalities in refractory focal and generalized epilepsy. Epilepsia. 2012 Aug;53(8):e137-40. doi: 10.1111/j.1528-1167.2012.03561.x. Epub 2012 Jun 18.
PubMed 22709423
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiac Rhythm Abnormalities in Patients With Refractory Epilepsy at High Risk for Sudden Death
- ClinicalTrials.gov ID
- NCT00203333
- Acronym / sponsor ID
- J05901
- Conditions
- Refractory Epilepsy, Arrhythmia, Sudden Death
- Keywords
- Epilepsy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Thomas Jefferson UniversityUniversity, hospital or other
- Collaborators
- Medtronic
- Study start
- Apr 2002
- Primary completion
- Jun 2007 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 20 Sep 2005 (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.
People with epilepsy are at a higher risk for sudden unexpected death than the general population. Sudden unexpected death in epilepsy (SUDEP) is a major cause of death in this population, accounting for 10-50% of deaths for those with epilepsy. The risk for SUDEP is particularly high for those with refractory epilepsy. Several lines of evidence support a cardiac mechanism for SUDEP.
This study plans to determine:
- the frequency and types of cardiac arrhythmias that occur in this population and
- whether these are increased above the general population in the same age group.
Additionally, these data will be correlated to specific clinical data, including seizure history, anticonvulsant medications, and any accompanying clinical symptoms.
Detailed description
By employing long-term electrocardiographic monitoring, this study plans to determine:
- the frequency and types of cardiac arrhythmias that occur in patients with uncontrolled seizures and
- whether these are increased above the general population in the same age group.
The specific aims:
- Identify the types, frequency, and duration of cardiac arrhythmias that occur in patients with refractory epilepsy and compare these data to available normative data.
- Correlate abnormal heart rates and rhythms to specific clinical data:
- seizure type,
- seizure frequency,
- probable location of seizure onset in the brain, when such data are available,
- duration of seizures, and
- type(s) and number of anticonvulsant medications being used.
- Correlate cardiac arrhythmias to clinical symptoms
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 16 to 49 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Individuals with refractory focal or generalized epilepsy.
Key inclusion criteria (1 listed)
- Refractory epilepsy
Key exclusion criteria (1 listed)
- Other pre-existing heart conditions
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 |
|---|---|---|
| Medtronic REVEAL | Device | – |
Primary outcome
Not reported in the source record.
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 18 Oct 2016.
- Results publication: PubMed 22709423Nei M, Sperling MR, Mintzer S, Ho RT. Long-term cardiac rhythm and repolarization abnormalities in refractory focal and generalized epilepsy. Epilepsia. 2012 Aug;53(8):e137-40. doi: 10.1111/j.1528-1167.2012.03561.x. Epub 2012 Jun 18.
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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.
Maromi Nei, MD principal investigator
Thomas Jefferson University
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 Refractory Epilepsy and Arrhythmia, run by Thomas Jefferson University 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 1 inclusion and 1 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 18 Oct 2016. 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00203333, which also lists 1 linked publication.
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 18 Oct 2016.