Neural Circulatory Control and SUDEP Risk. | NCT02813980

Studies
Neural Circulatory Control and SUDEP Risk.

NCT02813980

Sponsor

Mayo Clinic

Status

Active, not recruiting

Last Update Posted

Jun 18, 2025Actual

Enrollment

39Actual

Phase

Not provided

Conditions

Epilepsy
Seizures

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2025

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2016Actual

Primary Completion Date

Dec 2030Estimated

Completion Date

Dec 2030Estimated

First Submitted Date

Jun 22, 2016

First Submission Date that Met QC Criteria

Jun 22, 2016

First Posted Date

Jun 27, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 16, 2025

Last Update Posted Date

Jun 18, 2025Actual

Name	Class
American Heart Association	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

39Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
High SUDEP-7 score		Patients with epilepsy who have a high SUDEP-7 score
Low SUDEP-7 score		Patients with epilepsy who have a low SUDEP-7 score

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Abnormal neural circulatory control in patients with epilepsy and high SUDEP-7 scores compared to patients with epilepsy and low SUDEP-7 scores.		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.		3-7 days

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Patients with epilepsy.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Virend K Somers, MD PhD	Mayo Clinic	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Mayo Clinic		Rochester	Minnesota	55905	United States

Label	URL
Mayo Clinic Clinical Trials	View source

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D004827	Epilepsy
D012640	Seizures
D000080485	Sudden Unexpected Death in Epilepsy
D016757	Death, Sudden, Cardiac

Ancestor Terms

ID	Term
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases
D009461	Neurologic Manifestations

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