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NCT Number: NCT05981755

Breathing Rescue for SUDEP Prevention

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.

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Key information

Conditions

Focal Epilepsy Brain Diseases Central Nervous System Diseases Epilepsies, Partial Epilepsy Nervous System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

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

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

  2. Change in presence of breathing nodes as assessed by EEG signal

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

  3. Changes in thoracoabdominal circumference during stimulation as assessed by thoracoabdominal belts,

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

    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.

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

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

    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.

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

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

    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.

  6. Change in end tidal carbon dioxide (CO2) during stimulation

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

    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.

Secondary outcomes

  1. Quantification of the breathing changes as assessed by the change in breathing rate

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

    Breathing rate is the number of breaths taken per minute. Breathing changes will be visually identified live during stimulation sessions using thoraco-abdominal plethysmography and pressure transducer signal (nasal/oral airflow).

  2. Quantification of the breathing changes as assessed by the change in breathing depth

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

    Breathing depth, or tidal volume (TV), is the amount of air that normally enters the lungs during quiet breathing. Breathing changes will be visually identified live during stimulation sessions using thoraco-abdominal plethysmography and pressure transducer signal (nasal/oral airflow).

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

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

    Minute ventilation, also known as total ventilation, is a measurement of the amount of air that enters the lungs per minute. It is the product of respiratory rate and tidal volume. Breathing changes will be visually identified live during stimulation sessions using thoraco-abdominal plethysmography and pressure transducer signal (nasal/oral airflow).

Study contacts

Contact information is provided by the study sponsor or research team.

Nuria L Lecumberri, MD,PhD

CONTACT

[email protected]

713-500-7785

Sandhya Rani, PhD

CONTACT

[email protected]

713-500-7499

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Collaborators

  • National Institute of Neurological Disorders and Stroke (NINDS)

Registry information

Official study title

Breathing Rescue for SUDEP Prevention (BreatheS)

Acronym: BreatheS

Important dates

Study start
2023
Primary completion
2028
Study completion
2028
First posted
Aug 8, 2023
Registry last updated
Jun 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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