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

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ClinicalTrials.gov Identifier: NCT02813980
Recruitment Status : Recruiting
First Posted : June 27, 2016
Last Update Posted : March 22, 2019
Sponsor:
Collaborator:
American Heart Association
Information provided by (Responsible Party):
Virend Somers, 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 2020
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

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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.
Criteria

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 ClinicalTrials.gov identifier (NCT number): NCT02813980


Contacts
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Contact: Lisa D. Block 507 255 0492 CPL@mayo.edu
Contact: Somers CPL Lab CPL@mayo.edu

Locations
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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
Investigators
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Principal Investigator: Virend K Somers, MD PhD Mayo Clinic

Additional Information:
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Responsible Party: Virend Somers, PI, Mayo Clinic
ClinicalTrials.gov Identifier: NCT02813980     History of Changes
Other Study ID Numbers: 15-001421
First Posted: June 27, 2016    Key Record Dates
Last Update Posted: March 22, 2019
Last Verified: March 2019

Keywords provided by Virend Somers, Mayo Clinic:
SUDEP
Sudden cardiac death
Sudden unexpected death in epilepsy
Sleep
Polysomnography
Autonomic
Cardiovascular

Additional relevant MeSH terms:
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Epilepsy
Seizures
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms