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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Responder | A subject having at least a 50% reduction in total seizure frequency compared to the SANTE study 3-month Baseline Phase |
| |
| Non-responder | A subject with a less than 50% reduction in total seizure frequency compared to the SANTE study 3-month Baseline Phase. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| There was no intervention. | Device | There was no intervention. This study was designed as an in-clinic testing protocol to identify recruitment rhythms. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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The study will enroll the number of patients necessary to achieve the required sample size of 18 responders and 18 non-responders at a minimum of six (6) centers participating in the U.S. SANTE study.
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| ID | Term |
|---|---|
| D004827 | Epilepsy |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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