Clinical trial NCT05981755: Breathing Rescue for SUDEP Prevention
Official title: Breathing Rescue for SUDEP Prevention (BreatheS)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Focal Epilepsy
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
Collaborators: name: National Institute of Neurological Disorders and Stroke (NINDS)
First posted: 2023-08-08
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in percentage of breathing node size as assessed by electroencephalogram (EEG) signal
timeFrame: baseline (before breathing task), at the time of the breathing task (about 8 minutes after start of baseline)
measure: Change in presence of breathing nodes as assessed by EEG signal
timeFrame: Baseline (before breathing task), at the time of the breathing task(about 8 minutes after start of baseline)
measure: Changes in thoracoabdominal circumference during stimulation as assessed by thoracoabdominal belts,
timeFrame: Baseline, during the stimulation session (at least 2 hours after baseline)
measure: Changes airflow during stimulation as assessed by the nasal/oral pressure transducer [BiNAPS]
timeFrame: Baseline, during the stimulation session (at least 2 hours after baseline)
measure: Change in Saturation of peripheral oxygen (SpO2) during stimulation as assessed by the pulse oximetry
timeFrame: Baseline, during the stimulation session (at least 2 hours after baseline)
measure: Change in end tidal carbon dioxide (CO2) during stimulation
timeFrame: Baseline, during the stimulation session (at least 2 hours after baseline)
Secondary outcomes:
measure: Quantification of the breathing changes as assessed by the change in breathing rate
timeFrame: baseline (before stimulation), at the time of stimulation (about 8 minutes after start of baseline)
measure: Quantification of the breathing changes as assessed by the change in breathing depth
timeFrame: baseline (before stimulation), at the time of stimulation (about 8 minutes after start of baseline)
measure: Quantification of the breathing changes as assessed by the change in breathing minute ventilation (MV)
timeFrame: baseline (before stimulation), at the time of stimulation (about 8 minutes after start of baseline)
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Nuria L Lecumberri, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: