Recruiting

Breathing Rescue

Sponsor:

The University of Texas Health Science Center, Houston

Code:

NCT05981755

Conditions

Focal Epilepsy

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Breathing tasks

Brain mapping with stimulation

Study Details

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

Study ID

NCT05981755

Start date

Jul 31, 2023

Status verified date

Jun, 2025

Completion date

Jun 30, 2028

Anticipated

Primary completion date

Jun 30, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

100 participants

Anticipated

Intervention Model

Single group

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Breathing tasks and Brain mapping with stimulation

Interventions

Breathing tasks

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

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 outcome measure

  • 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) ]
  • 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) ]
  • Changes in thoracoabdominal circumference during stimulation as assessed by thoracoabdominal belts, [ Time Frame: Baseline, during the stimulation session (at least 2 hours after baseline) ]
  • 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) ]
  • 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) ]
  • Change in end tidal carbon dioxide (CO2) during stimulation [ Time Frame: Baseline, during the stimulation session (at least 2 hours after baseline) ]

Central Contacts and Locations

Central contacts

Nuria L Lecumberri, MD,PhD

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

Sandhya Rani, PhD

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

Locations

The University of Texas Health Science Center at Houston

Recruiting

Houston, Texas, United States, 77030

Contacts

Nuria L Lecumberri, MD,PhD

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

Sandhya Rani, PhD

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

More Information

Sponsor

The University of Texas Health Science Center, Houston

Last update posted

Jun 18, 2025

Last verified

Jun, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by The University of Texas Health Science Center, Houston on 2025-06-18.