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Breathing Rescue for SUDEP Prevention (BreatheS)

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ClinicalTrials.gov Identifier: NCT05981755
Recruitment Status : Recruiting
First Posted : August 8, 2023
Last Update Posted : December 12, 2023
Sponsor:
Collaborator:
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by (Responsible Party):
Nuria Lacuey Lecumberri, The University of Texas Health Science Center, Houston

Study Description
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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
Focal Epilepsy Other: Breathing tasks Device: Brain mapping with stimulation Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Breathing Rescue for SUDEP Prevention (BreatheS)
Actual Study Start Date : July 31, 2023
Estimated Primary Completion Date : June 30, 2028
Estimated Study Completion Date : June 30, 2028
Arms and Interventions
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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
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Primary Outcome Measures :
  1. 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) ]
  2. 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) ]
  3. 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.

  4. 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.

  5. 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.

  6. 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.


Secondary Outcome Measures :
  1. 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) ]
    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).

  2. 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) ]
    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).

  3. 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) ]
    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
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05981755


Contacts
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Contact: Nuria L Lecumberri, MD,PhD 713-500-7785 Nuria.Lacuey@uth.tmc.edu
Contact: Sandhya Rani, PhD 713-500-7499 M.R.Sandhya.Rani@uth.tmc.edu

Locations
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United States, Texas
The University of Texas Health Science Center at Houston Recruiting
Houston, Texas, United States, 77030
Contact: Nuria L Lecumberri, MD,PhD    713-500-7785    Nuria.Lacuey@uth.tmc.edu   
Contact: Sandhya Rani, PhD    713-500-7499    M.R.Sandhya.Rani@uth.tmc.edu   
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
National Institute of Neurological Disorders and Stroke (NINDS)
Investigators
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Principal Investigator: Nuria L Lecumberri, MD,PhD The University of Texas Health Science Center, Houston
More Information
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Responsible Party: Nuria Lacuey Lecumberri, Assistant Professor, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT05981755    
Other Study ID Numbers: HSC-MS-20-1228
R01NS133743 ( U.S. NIH Grant/Contract )
First Posted: August 8, 2023    Key Record Dates
Last Update Posted: December 12, 2023
Last Verified: December 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Epilepsies, Partial
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases