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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

29 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-01-31

Study Completion Date

2010-05-31

Brief Summary

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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.

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Refractory Epilepsy

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Detailed Description

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Conditions

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Epilepsy

Study Design

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Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Responder

A subject having at least a 50% reduction in total seizure frequency compared to the SANTE study 3-month Baseline Phase

There was no intervention.

Intervention Type DEVICE

There was no intervention. This study was designed as an in-clinic testing protocol to identify recruitment rhythms.

Non-responder

A subject with a less than 50% reduction in total seizure frequency compared to the SANTE study 3-month Baseline Phase.

There was no intervention.

Intervention Type DEVICE

There was no intervention. This study was designed as an in-clinic testing protocol to identify recruitment rhythms.

Interventions

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There was no intervention.

There was no intervention. This study was designed as an in-clinic testing protocol to identify recruitment rhythms.

Intervention Type DEVICE

Eligibility Criteria

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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