Brain Stimulation for Epilepsy Long Term Follow-up

Epilepsy Clinical Trial

— SUDEP  

Official title:

Brain Stimulation for Epilepsy Long Term Follow-up

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00736424
• Other study ID #: 1616
• Status: Completed
• Phase: N/A
• First received: June 24, 2008
• Last updated: January 10, 2014
• Start date: June 2008
• Est. completion date: November 2010

Study information

• Verified date: January 2014
• Source: MedtronicNeuro
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: November 2010
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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:

Study Design

Observational Model: Case-Only

Related Conditions & MeSH terms

• Epilepsy

Intervention

Device:
• Itrel II™ and Soletra™ Epilepsy Control System
Bilateral neurostimulation of the anterior nucleus of the thalamus

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
MedtronicNeuro

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		5 years (anticipated)	No

External Links

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