Trial record 8 of 1581 for:    "Mayo Clinic" [Exact]

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2016 by Mayo Clinic
Sponsor:
Information provided by (Responsible Party):
Virend Somers, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT02813980
First received: June 22, 2016
Last updated: NA
Last verified: June 2016
History: No changes posted
  Purpose
We 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 Intervention
Epilepsy
Seizures
Other: There are no interventions. This is a prospective observational study.

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Neural Circulatory and Respiratory Control in Patients With Epilepsy and the Risk of Sudden Unexpected Death.

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

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

Estimated Enrollment: 100
Study Start Date: June 2016
Estimated Study Completion Date: May 2018
Estimated Primary Completion Date: May 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

Detailed Description:
Our 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.
  Eligibility

Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Genders Eligible for Study:   Both
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)
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02813980

Contacts
Contact: Somers CPL Lab CPL@mayo.edu

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

Responsible Party: Virend Somers, PI, Mayo Clinic
ClinicalTrials.gov Identifier: NCT02813980     History of Changes
Other Study ID Numbers: 15-001421 
Study First Received: June 22, 2016
Last Updated: June 22, 2016
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on July 21, 2016