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

Refractory Epilepsy research study

What is the primary objective of 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: 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.

Who is eligible to participate?

Inclusion Criteria: - Refractory epilepsy Exclusion Criteria: - Other pre-existing heart conditions

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Refractory Epilepsy

Arrhythmia

Sudden Death

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Device:Medtronic REVEAL

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Study Status

Completed

Start Date: April 2002

Completed Date: January 2010

Phase: Phase 2/Phase 3

Type: Observational

Design:

Primary Outcome:

Secondary Outcome:

Study sponsors, principal investigator, and references

Principal Investigator: Maromi Nei, MD

Lead Sponsor: Thomas Jefferson University

Collaborator: Medtronic

More information:https://clinicaltrials.gov/show/NCT00203333

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.

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