Focal EpilepsyBreatheSNCT05981755
Breathing Rescue for SUDEP Prevention
A study testing Breathing tasks and Brain mapping with stimulation in people with Focal Epilepsy, run by The University of Texas Health Science Center, Houston at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Focal Epilepsy
- What is being tested?
- Breathing tasks and Brain mapping with stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Jul 2023to 30 Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- respiratory, cardiac or cerebrovascular disease
- pregnancy
- prisoners
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
Nuria L Lecumberri, MD,PhD, 713-500-7785, Nuria.Lacuey@uth.tmc.edu
Sandhya Rani, PhD, 713-500-7499, M.R.Sandhya.Rani@uth.tmc.edu
About this study
Official title: Breathing Rescue for SUDEP Prevention (BreatheS)
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.
- Conditions
- Focal Epilepsy
- Being tested
- Breathing tasks, Brain mapping with stimulation
- Medical subject headings
- Epilepsies, Partial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breathing tasksOther
Breathing tasks include normal breathing through nose or mouth, breathing while resting wakefully, increase and decrease in breathing rate, and breath counting.
Brain mapping with stimulationDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Breathing tasks and Brain mapping with stimulation | Experimental | Not described Receives: Other: Breathing tasks; Device: Brain mapping with stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in percentage of breathing node size as assessed by electroencephalogram (EEG) signal
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, during the stimulation session (at least 2 hours after baseline)
Secondary outcomes (3)
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).
Measured: 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).
Measured: 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).
Measured: baseline (before stimulation), at the time of stimulation (about 8 minutes after start of baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2023
- Study start31 Jul 2023
- Primary completion30 Jun 2028 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Focal EpilepsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Texas Health Science Center, Houston
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS)
- Responsible party
- Principal investigator, Nuria Lacuey Lecumberri, The University of Texas Health Science Center, Houston
- Investigators
- Nuria L Lecumberri, MD,PhD, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05981755
- Sponsor's protocol ID
- HSC-MS-20-1228
- Other IDs
- R01NS133743
- Acronym
- BreatheS
- Status last verified
- Jun 2025
- First submitted
- 21 Jul 2023
- Last updated
- 18 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Breathing Rescue for SUDEP Prevention (BreatheS)
- ClinicalTrials.gov ID
- NCT05981755
- Acronym / sponsor ID
- BreatheS / HSC-MS-20-1228
- Conditions
- Focal Epilepsy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS)
- Study start
- 31 Jul 2023 (actual)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 8 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Breathing tasks and Brain mapping with stimulation | Experimental | Other: Breathing tasks, Device: Brain mapping with stimulation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (3 listed)
- respiratory, cardiac or cerebrovascular disease
- pregnancy
- prisoners
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Breathing tasksBreathing tasks include normal breathing through nose or mouth, breathing while resting wakefully, increase and decrease in breathing rate, and breath counting. | Other | Breathing tasks and Brain mapping with stimulation |
| Brain mapping with stimulationElectrical 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. | Device | Breathing tasks and Brain mapping with stimulation |
Primary outcome
Change in percentage of breathing node size as assessed by electroencephalogram (EEG) signal
Time frame: 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
Time frame: 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,
Time frame: 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]
Time frame: 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
Time frame: 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
Time frame: 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.
3 secondary outcomes
Quantification of the breathing changes as assessed by the change in breathing rate
Time frame: 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
Time frame: 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)
Time frame: baseline (before stimulation), at the time of stimulation (about 8 minutes after start of baseline)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nuria L Lecumberri, MD,PhD principal investigator
The University of Texas Health Science Center, Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Breathing tasks and Brain mapping with stimulation in people with Focal Epilepsy, run by The University of Texas Health Science Center, Houston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nuria L Lecumberri, MD,PhD (713-500-7785, Nuria.Lacuey@uth.tmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in percentage of breathing node size as assessed by electroencephalogram (EEG) signal (time frame: baseline (before breathing task), at the time of the breathing task (about 8 minutes after start of baseline)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2025.