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

Medtronic

Status: Completed

Conditions: Epilepsy

Treatments: Device: There was no intervention.

Study type: Observational

Funder types: Industry

Identifiers

NCT00772421

1636

Details and patient eligibility

About

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.

Enrollment: 29 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

29 participants in 2 patient groups

Responder

Description:

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

Treatment:

Device: There was no intervention.

Non-responder

Description:

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

Treatment:

Device: There was no intervention.