Stimulation of the Anterior Nucleus of the Thalamus for Epilepsy - Recruitment Rhythm (SANTE RR)

MedtronicNeuro0 sites29 target enrollmentJanuary 2009

ConditionsEpilepsy

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Epilepsy
Sponsor: MedtronicNeuro
Enrollment: 29
Primary Endpoint: 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.
Status: Completed
Last Updated: 14 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

January 2009

End Date

May 2010

Last Updated

14 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

MedtronicNeuro

Responsible Party

Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

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.

Time Frame: Study testing to occur during the long-term follow-up phase of the SANTE trial.

Secondary Outcomes

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.)