CompletedNot Applicable

Brain Stimulation for Epilepsy Long Term Follow-up

9 participantsStarted 2008-06

Plain-language 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.

Who can participate

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

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.

Timeframe: 5 years (anticipated)

Trial details

NCT IDNCT00736424

SponsorMedtronicNeuro

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2010-11

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