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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
MedtronicNeuro
ClinicalTrials.gov Identifier:
NCT00736424
First received: June 24, 2008
Last updated: January 10, 2014
Last verified: January 2014
  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

Resource links provided by NLM:


Further study details as provided by MedtronicNeuro:

Primary Outcome Measures:
  • 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 ]

Enrollment: 9
Study Start Date: June 2008
Study Completion Date: November 2010
Primary Completion Date: November 2010 (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
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.

Criteria

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
No Contacts or Locations Provided
  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: January 10, 2014
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 April 23, 2014