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

Epilepsy Clinical Trial

— SANTE RR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00772421
• Other study ID #: 1636
• Status: Completed
• Phase: N/A
• First received: October 14, 2008
• Last updated: January 27, 2012
• Start date: January 2009
• Est. completion date: May 2010

Study information

• Verified date: January 2012
• Source: MedtronicNeuro
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: May 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Epilepsy

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
MedtronicNeuro

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Yes
Secondary	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.	Yes