Breathing Rescue for SUDEP Prevention

Focal Epilepsy Clinical Trial

— BreatheS  

Official title:

Breathing Rescue for SUDEP Prevention (BreatheS)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05981755
• Other study ID #: HSC-MS-20-1228
• Secondary ID: R01NS133743
• Status: Recruiting
• Phase: N/A
• Start date: July 31, 2023
• Est. completion date: June 30, 2028

Study information

• Verified date: December 2023
• Source: The University of Texas Health Science Center, Houston
• Contact: Nuria L Lecumberri, MD,PhD
• Phone: 713-500-7785
• Email: Nuria.Lacuey[@]uth.tmc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: June 30, 2028
• Est. primary completion date: June 30, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Epilepsies, Partial
• Focal Epilepsy

Intervention

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.

Locations

Country	Name	City	State
United States	The University of Texas Health Science Center at Houston	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston	National Institute of Neurological Disorders and Stroke (NINDS)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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	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)
Secondary	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)
Secondary	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)