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
1 other identifier
observational
29
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Jan 2009
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 14, 2008
CompletedFirst Posted
Study publicly available on registry
October 15, 2008
CompletedStudy Start
First participant enrolled
January 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2010
CompletedJanuary 31, 2012
January 1, 2012
1.3 years
October 14, 2008
January 27, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
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.
Study Arms (2)
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.
Interventions
There was no intervention. This study was designed as an in-clinic testing protocol to identify recruitment rhythms.
Eligibility Criteria
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.
You may qualify if:
- 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
You may not qualify if:
- Patients unable to tolerate stimulation turned OFF during the testing period
- Are pregnant or suspected of being pregnant
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- MedtronicNeurolead
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 14, 2008
First Posted
October 15, 2008
Study Start
January 1, 2009
Primary Completion
May 1, 2010
Study Completion
May 1, 2010
Last Updated
January 31, 2012
Record last verified: 2012-01