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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)

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ClinicalTrials.gov Identifier: NCT00772421
Recruitment Status : Completed
First Posted : October 15, 2008
Last Update Posted : January 31, 2012
Sponsor:
Information provided by (Responsible Party):
MedtronicNeuro

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.

Condition or disease Intervention/treatment
Epilepsy Device: There was no intervention.

Study Type : Observational
Actual Enrollment : 29 participants
Time Perspective: Cross-Sectional
Official Title: Stimulation of the Anterior Nucleus of the Thalamus for Epilepsy - Recruitment Rhythm (SANTE RR)
Study Start Date : January 2009
Actual Primary Completion Date : May 2010
Actual Study Completion Date : May 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Epilepsy
U.S. FDA Resources

Group/Cohort Intervention/treatment
Responder
A subject having at least a 50% reduction in total seizure frequency compared to the SANTE study 3-month Baseline Phase
Device: There was no intervention.
There was no intervention. This study was designed as an in-clinic testing protocol to identify recruitment rhythms.
Non-responder
A subject with a less than 50% reduction in total seizure frequency compared to the SANTE study 3-month Baseline Phase.
Device: There was no intervention.
There was no intervention. This study was designed as an in-clinic testing protocol to identify recruitment rhythms.



Primary Outcome Measures :
  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. [ Time Frame: Study testing to occur during the long-term follow-up phase of the SANTE trial. ]

Secondary Outcome Measures :
  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. [ Time Frame: Study testing to occur during the long-term follow-up phase of the SANTE trial. ]


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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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.
Criteria

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

Responsible Party: MedtronicNeuro
ClinicalTrials.gov Identifier: NCT00772421     History of Changes
Other Study ID Numbers: 1636
First Posted: October 15, 2008    Key Record Dates
Last Update Posted: January 31, 2012
Last Verified: January 2012

Keywords provided by MedtronicNeuro:
Epilepsy
Recruitment rhythm
DBS

Additional relevant MeSH terms:
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases