Neural Circulatory Control and SUDEP Risk.

Active, not recruiting

• Conditions: Epilepsy; Seizures

• Registration Number: NCT02813980
• Lead Sponsor: Mayo Clinic

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.

Detailed Description

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.

Study Timeline

• Study Start: 2016-06
• Study First Submitted: 2016-06-22
• Study First Submitted QC: 2016-06-22
• Study First Posted: 2016-06-27
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-07
• Last Update Posted: 2024-06-10
• Primary Completion: 2028-12
• Study Completion: 2028-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 39

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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
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

Trial Locations

Locations (1)

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States