Status:
COMPLETED
Brain Stimulation for Epilepsy Long Term Follow-up
Lead Sponsor:
MedtronicNeuro
Conditions:
Epilepsy
Eligibility:
All Genders
Brief Summary
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 peo...
Detailed Description
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...
Eligibility Criteria
Inclusion
- Have received bilateral AN stimulation of the anterior nucleus of the thalamus (AN) for epilepsy or are receiving it at the time of enrollment
- For patients with therapy active at the time of enrollment, ability of the patient or legal representative to understand and provide signed consent for participating in the study
- For patients with therapy permanently discontinued or died at time of enrollment, the IRB/REB has approved a waiver allowing collection of the data OR the ability of the patient or legal representative to understand and provide signed consent/medical authorization
Exclusion
- None
Key Trial Info
Start Date :
June 1 2008
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 1 2010
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT00736424
Start Date
June 1 2008
End Date
November 1 2010
Last Update
January 14 2014
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