Neural Circulatory Control and SUDEP Risk.

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Epilepsy Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Death Death, Sudden Death, Sudden, Cardiac Heart Arrest Heart Diseases Nervous System Diseases Neurologic Manifestations Pathologic Processes Pathological Conditions, Signs and Symptoms Seizures Signs and Symptoms Sudden Unexpected Death in Epilepsy

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Mayo Clinic

Rochester, Minnesota, 55905, United States

About this study

The investigators overall goals are to determine whether measures of neural-circulatory control during the interictal waking and sleep states, as well as during the ictal/peri-ictal periods, are associated with SUDEP-7 score risk profiles in refractory epilepsy patients, and to translate these measures into tools for risk-stratification and preventative strategies for SUDEP.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

Abnormal neural circulatory control in patients with epilepsy and high SUDEP-7 scores compared to patients with epilepsy and low SUDEP-7 scores.

Time frame: 24 hours
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.

Time frame: 3-7 days

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Collaborators

American Heart Association

Registry information

Official study title

Neural Circulatory and Respiratory Control in Patients With Epilepsy and the Risk of Sudden Unexpected Death.

Acronym: NC-SUDEP

Important dates

Study start: 2016
Primary completion: 2030
Study completion: 2030
First posted: Jun 27, 2016
Registry last updated: Jun 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Recruiting