Epilepsy Clinical Trial
Official title:
Brain Stimulation for Epilepsy Long Term Follow-up
The purpose of this study is to collect subject data to evaluate the rate of sudden unexplained death in epilepsy (SUDEP) with bilateral neurostimulation of the anterior nucleus of the thalamus in people diagnosed with refractory epilepsy. The data obtained from the physician initiated studies will be pooled with data collected in Medtronic-sponsored studies to assess SUDEP risk.
Medtronic is conducting a pivotal clinical trial entitled Stimulation of the Anterior
Nucleus of the Thalamus in Epilepsy (SANTÉ). One of the requirements of the SANTÉ study is
to evaluate the rate of sudden unexplained death in epilepsy (SUDEP). Medtronic is aware of
approximately 18 subjects with various types of epilepsy that have been treated with
neurostimulation of the anterior nucleus of the thalamus outside the SANTÉ trial under five
physician-sponsored studies. This protocol will initially collect information regarding the
physician-sponsored study subjects' status. The goal of this study is to pool these data
with the SANTÉ data for the purpose of estimating the SUDEP rate.
This is a multi-center, retrospective and prospective clinical study in patients previously
implanted with devices that provide bilateral neurostimulation of the anterior nucleus of
the thalamus during non-Medtronic-sponsored studies.
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Observational Model: Case-Only
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