Neural Circulatory Control and SUDEP Risk. (NCT02813980) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Neural Circulatory Control and SUDEP Risk.
United States39 participantsStarted 2016-06
Plain-language summary
The investigators believe epilepsy alters the way the body controls blood pressure, heart rate and breathing, and these changes increase the risk of sudden unexpected death in patients with epilepsy (SUDEP). SUDEP-7 is a risk scoring tool which may correlate with these changes to the heart and blood vessels. This research study measures those differences which may help identify new markers to help predict those patients at greatest risk in the future.
Who can participate
Age range
18 Years – 90 Years
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:
* Adults aged 18-90
* Able to consent
Exclusion Criteria:
* History of non-epileptic spells/seizures,
* Children/adolescents under age 18 years
* Pregnancy
* Non-compliance with Epilepsy Monitoring Unit safety procedures
* Unable to consent
* History of dysautonomia
* Chronic Obstructive Pulmonary Disease (COPD)
* Asthma (active requiring therapy)
* Pulmonary hypertension
* Known Structural Heart Disease
* Heart failure
* Myocardial infarction
* Stroke
* Seizures due to traumatic injury
* Prior surgery for epilepsy
* Vasculitis
* Raynaud's
* Smoking (current or within the last 6 months)
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.
1My doctor has mentioned SUDEP as a risk with my epilepsy — could you calculate my SUDEP-7 score and explain what it means for my personal risk level, since that score seems to be central to how this study groups patients?
2This trial is actively studying how the heart, blood vessels, and breathing are affected during and around seizures — is there anything in my seizure history or current monitoring that already suggests I might have those kinds of abnormalities?
3Since this study is no longer enrolling new participants, are there other active studies looking at cardiovascular or breathing changes in epilepsy that I might still be able to join, or would standard SUDEP risk management be a better focus for me right now?
4This research is in a phase listed as 'NA,' which suggests it's more about understanding the biology of SUDEP risk than testing a treatment — so how might the findings from a study like this eventually change how my epilepsy is managed, and should that affect decisions I make now?
5If the results of this trial show that abnormal heart and breathing control are linked to higher SUDEP risk, would that change the kinds of tests or monitoring you'd recommend for me going forward?
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
Abnormal neural circulatory control in patients with epilepsy and high SUDEP-7 scores compared to patients with epilepsy and low SUDEP-7 scores.
Timeframe: 24 hours
2
Abnormal neural and respiratory control in the ictal and peri-ictal phase of patients with epilepsy and a high SUDEP-7 score when compared to patients with epilepsy and a low SUDEP-7 score.