Breathing Rescue for SUDEP Prevention

Study Overview
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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.

Official Title
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Breathing Rescue for SUDEP Prevention (BreatheS)

Conditions
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Focal Epilepsy

Intervention / Treatment
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* Other: Breathing tasks
* Device: Brain mapping with stimulation


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Breathing tasks and Brain mapping with stimulation<br> | Other: Breathing tasks<br>* Breathing tasks include normal breathing through nose or mouth, breathing while resting wakefully, increase and decrease in breathing rate, and breath counting.<br>Device: Brain mapping with stimulation<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quantification of the breathing changes as assessed by the change in breathing rate | 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). | 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 | 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). | 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) | 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). | baseline (before stimulation), at the time of stimulation (about 8 minutes after start of baseline) |