Neural Circulatory Control and SUDEP Risk.

NCT02813980 | Active Not Recruiting

• 1 other identifier: 15-001421
• Study Type: observational
• Target: 39
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Epilepsy; Seizures

Keywords

SUDEP; Sudden cardiac death; Sudden unexpected death in epilepsy; Sleep; Polysomnography; Autonomic; Cardiovascular

Outcome Measures

Primary Outcomes (2)

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

  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.

  3-7 days

Study Arms (2)

High SUDEP-7 score

Patients with epilepsy who have a high SUDEP-7 score

Low SUDEP-7 score

Patients with epilepsy who have a low SUDEP-7 score

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with epilepsy.

You may qualify if:

• Adults aged 18-90
• Able to consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead
• American Heart Association: collaborator

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum and plasma to be stored for future biomarker based studies.

MeSH Terms

Conditions

Epilepsy; Seizures; Sudden Unexpected Death in Epilepsy; Death, Sudden, Cardiac

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Death, Sudden; Death; Pathologic Processes; Heart Arrest; Heart Diseases; Cardiovascular Diseases

Study Officials

• Virend K Somers, MD PhD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PI

Study Record Dates

• First Submitted: June 22, 2016
• First Posted: June 27, 2016
• Study Start: June 1, 2016
• Primary Completion (Estimated): December 1, 2030
• Study Completion (Estimated): December 1, 2030
• Last Updated: June 18, 2025

Record last verified: 2025-06

Locations

US (1)