Breathing Rescue for SUDEP Prevention

NCT05981755 | Recruiting FDA Device

• 2 other identifiers: HSC-MS-20-1228R01NS133743
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Focal Epilepsy

Outcome Measures

Primary Outcomes (6)

• Change in percentage of breathing node size as assessed by electroencephalogram (EEG) signal

  baseline (before breathing task), at the time of the breathing task (about 8 minutes after start of baseline)

• Change in presence of breathing nodes as assessed by EEG signal

  Baseline (before breathing task), at the time of the breathing task(about 8 minutes after start of baseline)

• Changes in thoracoabdominal circumference during stimulation as assessed by thoracoabdominal belts,

  Lower and higher frequencies up to 50 Hertz(Hz), current of 1-10 milli ampere (mA), pulse durations of 0.2 milli second (msec) and stimulation periods of 10 to 40 seconds will be used.

  Baseline, during the stimulation session (at least 2 hours after baseline)

• Changes airflow during stimulation as assessed by the nasal/oral pressure transducer [BiNAPS]

  Lower and higher frequencies up to 50Hz, current of 1-10mA, pulse durations of 0.2 msec and stimulation periods of 10 to 40 seconds will be used.

  Baseline, during the stimulation session (at least 2 hours after baseline)

• Change in Saturation of peripheral oxygen (SpO2) during stimulation as assessed by the pulse oximetry

  Lower and higher frequencies up to 50Hz, current of 1-10mA, pulse durations of 0.2 msec and stimulation periods of 10 to 40 seconds will be used.

  Baseline, during the stimulation session (at least 2 hours after baseline)

• Change in end tidal carbon dioxide (CO2) during stimulation

  Lower and higher frequencies up to 50Hz, current of 1-10mA, pulse durations of 0.2 msec and stimulation periods of 10 to 40 seconds will be used.

  Baseline, during the stimulation session (at least 2 hours after baseline)

Secondary Outcomes (3)

• Quantification of the breathing changes as assessed by the change in breathing rate

  baseline (before stimulation), at the time of stimulation (about 8 minutes after start of baseline)

• Quantification of the breathing changes as assessed by the change in breathing depth

  baseline (before stimulation), at the time of stimulation (about 8 minutes after start of baseline)

• Quantification of the breathing changes as assessed by the change in breathing minute ventilation (MV)

  baseline (before stimulation), at the time of stimulation (about 8 minutes after start of baseline)

Study Arms (1)

Breathing tasks and Brain mapping with stimulation

EXPERIMENTAL

Other: Breathing tasks; Device: Brain mapping with stimulation

Interventions

Breathing tasks OTHER

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

Breathing tasks and Brain mapping with stimulation

Brain mapping with stimulation 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.

Breathing tasks and Brain mapping with stimulation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• respiratory, cardiac or cerebrovascular disease
• pregnancy
• prisoners

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead
• National Institute of Neurological Disorders and Stroke (NINDS): collaborator

Study Sites (1)

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

RECRUITING

MeSH Terms

Conditions

Epilepsies, Partial

Interventions

Brain Mapping

Condition Hierarchy (Ancestors)

Epilepsy; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Functional Neuroimaging; Neuroimaging; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Neurological; Investigative Techniques

Study Officials

• Nuria L Lecumberri, MD,PhD

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nuria L Lecumberri, MD,PhD

CONTACT

713-500-7785; Nuria.Lacuey@uth.tmc.edu

Sandhya Rani, PhD

CONTACT

713-500-7499; M.R.Sandhya.Rani@uth.tmc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: July 21, 2023
• First Posted: August 8, 2023
• Study Start: July 31, 2023
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): June 30, 2028
• Last Updated: June 18, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)