BreatheS: Breathing Rescue for SUDEP Prevention
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Breathing tasks and Brain mapping with stimulation
|
Other: Breathing tasks
Breathing tasks include normal breathing through nose or mouth, breathing while resting wakefully, increase and decrease in breathing rate, and breath counting.
Device: 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.
|
Outcome Measures
Primary Outcome Measures
- 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
- 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 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 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).
Eligibility Criteria
Criteria
Inclusion Criteria:
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diagnosis of intractable focal epilepsy
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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:
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respiratory, cardiac or cerebrovascular disease
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pregnancy
-
prisoners
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | The University of Texas Health Science Center at Houston | Houston | Texas | United States | 77030 |
Sponsors and Collaborators
- The University of Texas Health Science Center, Houston
- National Institute of Neurological Disorders and Stroke (NINDS)
Investigators
- Principal Investigator: Nuria L Lecumberri, MD,PhD, The University of Texas Health Science Center, Houston
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- HSC-MS-20-1228
- R01NS133743