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)
January 27, 2012 updated by: MedtronicNeuro
Stimulation of the Anterior Nucleus of the Thalamus for Epilepsy - Recruitment Rhythm (SANTE RR)
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.
Study Overview
Study Type
Observational
Enrollment (Actual)
29
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
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.
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
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
|
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.
|
There was no intervention.
This study was designed as an in-clinic testing protocol to identify recruitment rhythms.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
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.
|
Study testing to occur during the long-term follow-up phase of the SANTE trial.
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
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.
|
Study testing to occur during the long-term follow-up phase of the SANTE trial.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2009
Primary Completion (Actual)
May 1, 2010
Study Completion (Actual)
May 1, 2010
Study Registration Dates
First Submitted
October 14, 2008
First Submitted That Met QC Criteria
October 14, 2008
First Posted (Estimate)
October 15, 2008
Study Record Updates
Last Update Posted (Estimate)
January 31, 2012
Last Update Submitted That Met QC Criteria
January 27, 2012
Last Verified
January 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1636
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.