Breathing Rescue for SUDEP Prevention

Not Applicable

Recruiting

• Conditions: Focal Epilepsy
• Interventions: Other: Breathing tasks; Device: Brain mapping with stimulation

• Registration Number: NCT05981755
• Lead Sponsor: The University of Texas Health Science Center, Houston

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-07-21
• Study Start: 2023-07-31
• Study First Submitted QC: 2023-07-31
• Study First Posted: 2023-08-08
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-11
• Last Update Posted: 2023-12-12
• Primary Completion: 2028-06-30
• Study Completion: 2028-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Breathing tasks and Brain mapping with stimulation	Breathing tasks	-
Breathing tasks and Brain mapping with stimulation	Brain mapping with stimulation	-

Primary Outcome Measures

Name	Time	Method
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,	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.
Changes airflow during stimulation as assessed by the nasal/oral pressure transducer [BiNAPS]	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.
Change in Saturation of peripheral oxygen (SpO2) during stimulation as assessed by the pulse oximetry	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.
Change in end tidal carbon dioxide (CO2) during stimulation	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 Outcome Measures

Name	Time	Method
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)	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).
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)	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).
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)	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).

Trial Locations

Locations (1)

The University of Texas Health Science Center at Houston; 🇺🇸 Houston, Texas, United States