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Neural Circulatory Control and SUDEP Risk. (NC-SUDEP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02813980
Recruitment Status : Recruiting
First Posted : June 27, 2016
Last Update Posted : July 7, 2020
American Heart Association
Information provided by (Responsible Party):
Virend Somers, MD, PhD, 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.

Condition or disease Intervention/treatment
Epilepsy Seizures Other: There are no interventions. This is a prospective observational study.

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.

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Neural Circulatory and Respiratory Control in Patients With Epilepsy and the Risk of Sudden Unexpected Death.
Study Start Date : June 2016
Estimated Primary Completion Date : May 2022
Estimated Study Completion Date : May 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Epilepsy

Group/Cohort Intervention/treatment
High SUDEP-7 score
Patients with epilepsy who have a high SUDEP-7 score
Other: There are no interventions. This is a prospective observational study.
Low SUDEP-7 score
Patients with epilepsy who have a low SUDEP-7 score
Other: There are no interventions. This is a prospective observational study.

Primary Outcome Measures :
  1. 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 ]
  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. [ Time Frame: 3-7 days ]

Biospecimen Retention:   Samples Without DNA
Serum and plasma to be stored for future biomarker based studies.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with epilepsy.

Inclusion Criteria:

  • Adults aged 18-50
  • 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02813980

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Contact: Lisa D. Block 507 255 0492
Contact: Somers CPL Lab

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United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Sub-Investigator: Erik K St. Louis, MD         
Sub-Investigator: Anwar A Chahal, MD MRCP         
Sub-Investigator: Michael J Ackerman, MD PhD         
Sub-Investigator: Peter A Brady, MD FRCP FHRS         
Sponsors and Collaborators
Mayo Clinic
American Heart Association
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Principal Investigator: Virend K Somers, MD PhD Mayo Clinic
Additional Information:
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Responsible Party: Virend Somers, MD, PhD, PI, Mayo Clinic Identifier: NCT02813980    
Other Study ID Numbers: 15-001421
First Posted: June 27, 2016    Key Record Dates
Last Update Posted: July 7, 2020
Last Verified: July 2020
Keywords provided by Virend Somers, MD, PhD, Mayo Clinic:
Sudden cardiac death
Sudden unexpected death in epilepsy
Additional relevant MeSH terms:
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Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations