Brain Stimulation for Epilepsy Long Term Follow-up (NCT00736424) | Clinical Trial Compass
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
Sex
ALL
See this in plain English?
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this study has already been completed and was focused on collecting long-term data about a specific risk called SUDEP — sudden unexpected death in epilepsy — can you explain what SUDEP is, how real that risk is for someone with my type of epilepsy, and what my personal risk level looks like?
2This trial involved deep brain stimulation targeting a specific part of the brain called the anterior nucleus of the thalamus — is that type of brain stimulation something that might be appropriate for my situation, and how would I even find out if I'm a candidate?
3Because this was a long-term follow-up study rather than a standard treatment trial, the data collected here was mainly about tracking safety outcomes over time — does that mean there's enough evidence now about the risks and benefits of this approach for my doctor to feel confident recommending it, or is it still considered experimental?
4Since this study enrolled people described as having 'refractory epilepsy,' meaning seizures that haven't responded well to medications, would my doctor consider my epilepsy to fall into that category, and if so, what treatment paths — including or beyond brain stimulation — should I be exploring?
5Are there standard treatments or other clinical trials currently enrolling that my doctor thinks I should consider before or alongside looking into deep brain stimulation?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
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.