Breathing Rescue for SUDEP Prevention

NCT ID: NCT05981755

Last Updated: 2025-06-18

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

RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-31

Study Completion Date

2028-06-30

Brief Summary

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The purpose of this study is to precisely delineate human brain networks that modulate respiration and identify specific brain areas and stimulation techniques that can be used to prevent seizure-induced breathing failure.

Detailed Description

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Conditions

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Focal Epilepsy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Breathing tasks and Brain mapping with stimulation

Group Type EXPERIMENTAL

Breathing tasks

Intervention Type OTHER

Breathing tasks include normal breathing through nose or mouth, breathing while resting wakefully, increase and decrease in breathing rate, and breath counting.

Brain mapping with stimulation

Intervention Type DEVICE

Electrical stimulation will be used to find specific areas of the brain involved in breathing function. Stimulation will be applied using a Nihon Kohden MEE-1000A neural function measuring system with the MS-120BK extension unit for brain stimulation.

Interventions

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Breathing tasks

Breathing tasks include normal breathing through nose or mouth, breathing while resting wakefully, increase and decrease in breathing rate, and breath counting.

Intervention Type OTHER

Brain mapping with stimulation

Electrical stimulation will be used to find specific areas of the brain involved in breathing function. Stimulation will be applied using a Nihon Kohden MEE-1000A neural function measuring system with the MS-120BK extension unit for brain stimulation.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* diagnosis of intractable focal epilepsy
* admitted to the Epilepsy Monitoring Unit (EMU) at Memorial Hermann-Texas Medical Center for intracranial subdural strips, grids, or depth electrode placement study (invasive video-EEG)

Exclusion Criteria

* respiratory, cardiac or cerebrovascular disease
* pregnancy
* prisoners
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Neurological Disorders and Stroke (NINDS)

NIH

Sponsor Role collaborator

The University of Texas Health Science Center, Houston

OTHER

Sponsor Role lead

Responsible Party

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Nuria Lacuey Lecumberri

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Nuria L Lecumberri, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

The University of Texas Health Science Center, Houston

Locations

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The University of Texas Health Science Center at Houston

Houston, Texas, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Nuria L Lecumberri, MD,PhD

Role: CONTACT

713-500-7785

Sandhya Rani, PhD

Role: CONTACT

713-500-7499

Facility Contacts

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Nuria L Lecumberri, MD,PhD

Role: primary

713-500-7785

Sandhya Rani, PhD

Role: backup

713-500-7499

Other Identifiers

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R01NS133743

Identifier Type: NIH

Identifier Source: secondary_id

View Link

HSC-MS-20-1228

Identifier Type: -

Identifier Source: org_study_id

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