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

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Mayo Clinic

Status

Active, not recruiting

Conditions

Seizures
Epilepsy

Treatments

Other: There are no interventions. This is a prospective observational study.

Study type

Observational

Funder types

Other

Identifiers

NCT02813980
15-001421

Details and patient eligibility

About

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.

Full 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.

Enrollment

39 patients

Sex

All

Ages

18 to 90 years old

Volunteers

No Healthy Volunteers

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)

Trial design

39 participants in 2 patient groups

High SUDEP-7 score
Description:
Patients with epilepsy who have a high SUDEP-7 score
Low SUDEP-7 score
Description:
Patients with epilepsy who have a low SUDEP-7 score

Trial contacts and locations

1

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Central trial contact

Somers CPL Lab; Laura Hammel

Data sourced from clinicaltrials.gov

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