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

Medtronic

Status: Completed

Conditions: Epilepsy

Treatments: Device: Itrel II™ and Soletra™ Epilepsy Control System

Study type: Observational

Funder types: Industry

Identifiers

NCT00736424

1616

Details and patient eligibility

About

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.

Full 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.

Enrollment: 9 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

9 participants in 1 patient group

1

Description:

Have received bilateral AN stimulation of the anterior nucleus (AN) of the thalamus for epilepsy or are receiving it at the time of enrollment

Treatment:

Device: Itrel II™ and Soletra™ Epilepsy Control System