Stimulation of the Anterior Nucleus of the Thalamus for Epilepsy - Recruitment Stimulation of the Anterior Nucleus of the Thalamus for Epilepsy - Recruitment Rhythm

Completed

• Conditions: Epilepsy
• Interventions: Device: There was no intervention.

• Registration Number: NCT00772421
• Lead Sponsor: MedtronicNeuro

Brief Summary

The primary objective is to demonstrate that a higher proportion of responders to deep brain stimulation (DBS) in the anterior nucleus (AN) of the thalamus in refractory epilepsy patients in the SANTE study exhibit a recruitment rhythm relative to non-responders.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-10-14
• Study First Submitted QC: 2008-10-14
• Study First Posted: 2008-10-15
• Study Start: 2009-01
• Primary Completion: 2010-05
• Study Completion: 2010-05
• Status Verified: 2012-01
• Last Update Submitted: 2012-01-27
• Last Update Posted: 2012-01-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 29

Inclusion Criteria

• Enrolled in the SANTÉ study, have been implanted with a complete DBS system, and is currently receiving stimulation in the long-term follow-up phase (post Month 13) of the study
• Patient or legal representative is able to understand and provide signed consent for participating in the study
• Willing and available to attend the visit as scheduled and to comply with the study protocol

Exclusion Criteria

• Patients unable to tolerate stimulation turned OFF during the testing period
• Are pregnant or suspected of being pregnant

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Responder	There was no intervention.	A subject having at least a 50% reduction in total seizure frequency compared to the SANTE study 3-month Baseline Phase
Non-responder	There was no intervention.	A subject with a less than 50% reduction in total seizure frequency compared to the SANTE study 3-month Baseline Phase.

Primary Outcome Measures

Name	Time	Method
To demonstrate that a higher proportion of DBS responders exhibit a RR relative to non-responders, using maximum tolerated voltage settings, at activated electrode contacts used for DBS stimulation in the SANTE study.	Study testing to occur during the long-term follow-up phase of the SANTE trial.

Secondary Outcome Measures

Name	Time	Method
For patients without a RR at their activated DBS electrode contacts used in the SANTE study, demonstrate that activating other electrode contacts generates a RR.	Study testing to occur during the long-term follow-up phase of the SANTE trial.