Neural Circulatory Control and SUDEP Risk.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

39 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-06-30

Study Completion Date

2030-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Epilepsy Seizures

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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High SUDEP-7 score

Patients with epilepsy who have a high SUDEP-7 score

No interventions assigned to this group

Low SUDEP-7 score

Patients with epilepsy who have a low SUDEP-7 score

No interventions assigned to this group

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No