Brain Stimulation for Epilepsy Long Term Follow-up

NCT00736424 | Completed DMC

• 1 other identifier: 1616
• Study Type: observational
• Target: 9
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Epilepsy

Keywords

Epilepsy; SUDEP; DBS

Outcome Measures

Primary Outcomes (1)

• 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)

Study Arms (1)

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

Interventions

Itrel II™ and Soletra™ Epilepsy Control System DEVICE

Bilateral neurostimulation of the anterior nucleus of the thalamus

1

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• None

Sponsors & Collaborators

• MedtronicNeuro: lead

Related Links

• Related Info

MeSH Terms

Conditions

Epilepsy; Sudden Unexpected Death in Epilepsy

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Death, Sudden; Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2008
• First Posted: August 15, 2008
• Study Start: June 1, 2008
• Primary Completion: November 1, 2010
• Study Completion: November 1, 2010
• Last Updated: January 14, 2014

Record last verified: 2014-01