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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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 November 25, 2014