Epilepsy
Conditions
Keywords
Epilepsy, Recruitment rhythm, DBS
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.
Interventions
There was no intervention. This study was designed as an in-clinic testing protocol to identify recruitment rhythms.
Sponsors
MedtronicNeuro
Study design
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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. |
Secondary
| Measure | 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. |
Outcome results
None listed