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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.
 
ClinicalTrials.gov Identifier: NCT02813980
Recruitment Status : Recruiting
First Posted : June 27, 2016
Last Update Posted : July 7, 2020
Sponsor:
Collaborator:
American Heart Association
Information provided by (Responsible Party):
Virend Somers, MD, PhD, Mayo Clinic

Tracking Information
First Submitted Date June 22, 2016
First Posted Date June 27, 2016
Last Update Posted Date July 7, 2020
Study Start Date June 2016
Estimated Primary Completion Date May 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 22, 2016)
  • 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 ]
  • 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 ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Neural Circulatory Control and SUDEP Risk.
Official Title Neural Circulatory and Respiratory Control in Patients With Epilepsy and the Risk of Sudden Unexpected Death.
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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
Serum and plasma to be stored for future biomarker based studies.
Sampling Method Probability Sample
Study Population Patients with epilepsy.
Condition
  • Epilepsy
  • Seizures
Intervention Other: There are no interventions. This is a prospective observational study.
Study Groups/Cohorts
  • High SUDEP-7 score
    Patients with epilepsy who have a high SUDEP-7 score
    Intervention: 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
    Intervention: Other: There are no interventions. This is a prospective observational study.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: June 22, 2016)
100
Original Estimated Enrollment Same as current
Estimated Study Completion Date May 2022
Estimated Primary Completion Date May 2022   (Final data collection date for primary outcome measure)
Eligibility 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)
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Lisa D. Block 507 255 0492 CPL@mayo.edu
Contact: Somers CPL Lab CPL@mayo.edu
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02813980
Other Study ID Numbers 15-001421
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Virend Somers, MD, PhD, Mayo Clinic
Study Sponsor Mayo Clinic
Collaborators American Heart Association
Investigators
Principal Investigator: Virend K Somers, MD PhD Mayo Clinic
PRS Account Mayo Clinic
Verification Date July 2020