Brain Stimulation for Epilepsy Long Term Follow-up (SUDEP)

January 10, 2014 updated by: MedtronicNeuro
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

9

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

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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.

Description

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

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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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)
5 years (anticipated)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

MedtronicNeuro

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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

June 1, 2008

Primary Completion (ACTUAL)

November 1, 2010

Study Completion (ACTUAL)

November 1, 2010

Study Registration Dates

First Submitted

June 24, 2008

First Submitted That Met QC Criteria

August 13, 2008

First Posted (ESTIMATE)

August 15, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

January 14, 2014

Last Update Submitted That Met QC Criteria

January 10, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1616

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.

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