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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)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
MedtronicNeuro
ClinicalTrials.gov Identifier:
NCT00772421
First received: October 14, 2008
Last updated: January 27, 2012
Last verified: January 2012
History of Changes
  Purpose

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 Intervention
Epilepsy
 Device: There was no intervention.

Study Type: Observational
Study Design: Time Perspective: Cross-Sectional
Official Title: Stimulation of the Anterior Nucleus of the Thalamus for Epilepsy - Recruitment Rhythm (SANTE RR)

Resource links provided by NLM:

MedlinePlus related topics: Epilepsy
U.S. FDA Resources

Further study details as provided by MedtronicNeuro:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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. ] [ Designated as safety issue: Yes ]

Enrollment: 29
Study Start Date: January 2009
Study Completion Date: May 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

  Eligibility

Genders Eligible for Study:   Both
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
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: MedtronicNeuro
ClinicalTrials.gov Identifier: NCT00772421     History of Changes
Other Study ID Numbers: 1636
Study First Received: October 14, 2008
Last Updated: January 27, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by MedtronicNeuro:
Epilepsy
Recruitment rhythm
DBS

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

ClinicalTrials.gov processed this record on May 19, 2013