Neural Circulatory Control and SUDEP Risk.

Epilepsy Clinical Trial

— NC-SUDEP  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02813980
• Other study ID #: 15-001421
• Status: Active, not recruiting
• Start date: June 2016
• Est. completion date: December 2028

Study information

• Verified date: June 2024
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 39
• Est. completion date: December 2028
• Est. primary completion date: December 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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)

Related Conditions & MeSH terms

• Epilepsy
• Seizures

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Mayo Clinic	American Heart Association

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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

External Links

•   Mayo Clinic Clinical Trials