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CompletedNCT00203333Updated Oct 18, 2016

Cardiac Rhythm Abnormalities in Patients With Refractory Epilepsy at High Risk for Sudden Death

An observational study in Refractory Epilepsy, Arrhythmia and Sudden Death, sponsored by Thomas Jefferson University. Completed at 1 site in United States. Open to participants aged 16 Years to 49 Years. Per ClinicalTrials.gov, last updated 2016-10-18.

Sponsored by Thomas Jefferson University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
19
Ages
16 Years to 49 Years
Sex
All
01

Study 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. 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:

  1. the frequency and types of cardiac arrhythmias that occur in this population and
  2. 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:

  1. the frequency and types of cardiac arrhythmias that occur in patients with uncontrolled seizures and
  2. whether these are increased above the general population in the same age group.

The specific aims:

  1. Identify the types, frequency, and duration of cardiac arrhythmias that occur in patients with refractory epilepsy and compare these data to available normative data.

  2. Correlate abnormal heart rates and rhythms to specific clinical data:

    1. seizure type,
    2. seizure frequency,
    3. probable location of seizure onset in the brain, when such data are available,
    4. duration of seizures, and
    5. type(s) and number of anticonvulsant medications being used.
  3. Correlate cardiac arrhythmias to clinical symptoms
02

Conditions studied

  • Refractory Epilepsy
  • Arrhythmia
  • Sudden Death

Keywords

  • Epilepsy
03

In context

Epilepsy

1,805 studies on the registry are indexed under Epilepsy; 417 are open to participants now.

This study's enrollment of 19 is below the median of 102 across 521 observational studies indexed under Epilepsy.

Browse Epilepsy studies →

Lead sponsor

Thomas Jefferson University is the lead sponsor of 384 studies on the registry; 71 are open to participants now.

Of its 44 completed or terminated interventional studies of FDA-regulated products, 20 (45%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
16 Years to 49 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Individuals with refractory focal or generalized epilepsy.

Inclusion criteria

  • Refractory epilepsy

Exclusion criteria

Exclusion Criteria:

  • Other pre-existing heart conditions
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
19 participants (actual)

Interventions

  • DeviceMedtronic REVEAL
06

Study locations

1 site
  • Thomas Jefferson University
    Philadelphia, Pennsylvania 19107, United States
07

References and documents

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 ↗
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 18, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00203333
Lead sponsor
Thomas Jefferson University
Collaborators
Medtronic
Responsible party
Sponsor
First posted
Sep 20, 2005
Start date
Apr 2002
Primary completion
Jun 2007
Completion
Jan 2010
Last update
Oct 18, 2016

Study contacts

Maromi Nei, MD
principal investigator · Thomas Jefferson University

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2016. You cannot join it, but the record below documents what was studied.

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