Brain Stimulation for Epilepsy Long Term Follow-up (SUDEP)
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Purpose
The purpose of this study is to collect subject data to evaluate the rate of sudden unexplained death in epilepsy (SUDEP) with bilateral neurostimulation of the anterior nucleus of the thalamus in people diagnosed with refractory epilepsy. The data obtained from the physician initiated studies will be pooled with data collected in Medtronic-sponsored studies to assess SUDEP risk.
| Condition | Intervention |
|---|---|
|
Epilepsy |
Device: Itrel II™ and Soletra™ Epilepsy Control System |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Only |
| Official Title: | Brain Stimulation for Epilepsy Long Term Follow-up |
- The primary objective is to collect patient data that may be pooled with other data to estimate the SUDEP rate in people with refractory epilepsy receiving bilateral deep brain stimulation of the anterior nucleus of the thalamus. [ Time Frame: 5 years (anticipated) ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 18 |
| Study Start Date: | June 2008 |
| Estimated Primary Completion Date: | June 2013 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
1
Have received bilateral AN stimulation of the anterior nucleus (AN) of the thalamus for epilepsy or are receiving it at the time of enrollment
|
Device: Itrel II™ and Soletra™ Epilepsy Control System
Bilateral neurostimulation of the anterior nucleus of the thalamus
|
Detailed Description:
Medtronic is conducting a pivotal clinical trial entitled Stimulation of the Anterior Nucleus of the Thalamus in Epilepsy (SANTÉ). One of the requirements of the SANTÉ study is to evaluate the rate of sudden unexplained death in epilepsy (SUDEP). Medtronic is aware of approximately 18 subjects with various types of epilepsy that have been treated with neurostimulation of the anterior nucleus of the thalamus outside the SANTÉ trial under five physician-sponsored studies. This protocol will initially collect information regarding the physician-sponsored study subjects' status. The goal of this study is to pool these data with the SANTÉ data for the purpose of estimating the SUDEP rate.
This is a multi-center, retrospective and prospective clinical study in patients previously implanted with devices that provide bilateral neurostimulation of the anterior nucleus of the thalamus during non-Medtronic-sponsored studies.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
The study will initially include five sites that conducted physician-sponsored studies in the US and Canada. Centers may be added as additional patients are identified.
Inclusion Criteria:
- Have received bilateral AN stimulation of the anterior nucleus of the thalamus (AN) for epilepsy or are receiving it at the time of enrollment
- For patients with therapy active at the time of enrollment, ability of the patient or legal representative to understand and provide signed consent for participating in the study
- For patients with therapy permanently discontinued or died at time of enrollment, the IRB/REB has approved a waiver allowing collection of the data OR the ability of the patient or legal representative to understand and provide signed consent/medical authorization
Exclusion Criteria:
- None
Contacts and Locations More Information
No publications provided
| Responsible Party: | MedtronicNeuro |
| ClinicalTrials.gov Identifier: | NCT00736424 History of Changes |
| Other Study ID Numbers: | 1616 |
| Study First Received: | June 24, 2008 |
| Last Updated: | October 5, 2011 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by MedtronicNeuro:
|
Epilepsy SUDEP DBS |
Additional relevant MeSH terms:
|
Epilepsy Brain Diseases Central Nervous System Diseases Nervous System Diseases |
ClinicalTrials.gov processed this record on May 23, 2013