Cardiac Rhythm Abnormalities in Patients With Refractory Epilepsy at High Risk for Sudden Death
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.
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
Study Design
Time Perspective: Prospective
Conditions
Refractory Epilepsy
Intervention
Medtronic REVEAL
Location
Thomas Jefferson University
Philadelphia
Pennsylvania
United States
19107
Status
Recruiting
Source
Thomas Jefferson University
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00203333
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Vagus Nerve Stimulation
An adjunctive treatment for PARTIAL EPILEPSY and refractory DEPRESSION that delivers electrical impulses to the brain via the VAGUS NERVE. A battery implanted under the skin supplies the energy.
Anemia, Refractory, With Excess Of Blasts
Chronic refractory anemia with granulocytopenia, and/or thrombocytopenia. Myeloblasts and progranulocytes constitute 5 to 40 percent of the nucleated marrow cells.
Refractory Period, Electrophysiological
The period of time following the triggering of an ACTION POTENTIAL when the CELL MEMBRANE has changed to an unexcitable state and is gradually restored to the resting (excitable) state. During the absolute refractory period no other stimulus can trigger a response. This is followed by the relative refractory period during which the cell gradually becomes more excitable and the stronger impulse that is required to illicit a response gradually lessens to that required during the resting state.
Myoclonic Epilepsy, Juvenile
A disorder characterized by the onset of myoclonus in adolescence, a marked increase in the incidence of absence seizures (see EPILEPSY, ABSENCE), and generalized major motor seizures (see EPILEPSY, TONIC-CLONIC). The myoclonic episodes tend to occur shortly after awakening. Seizures tend to be aggravated by sleep deprivation and alcohol consumption. Hereditary and sporadic forms have been identified. (From Adams et al., Principles of Neurology, 6th ed, p323)
Epilepsy
A disorder characterized by recurrent episodes of paroxysmal brain dysfunction due to a sudden, disorderly, and excessive neuronal discharge. Epilepsy classification systems are generally based upon: (1) clinical features of the seizure episodes (e.g., motor seizure), (2) etiology (e.g., post-traumatic), (3) anatomic site of seizure origin (e.g., frontal lobe seizure), (4) tendency to spread to other structures in the brain, and (5) temporal patterns (e.g., nocturnal epilepsy). (From Adams et al., Principles of Neurology, 6th ed, p313)
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