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Breathing Rescue for SUDEP Prevention (BreatheS)

Primary Purpose

Focal Epilepsy

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Breathing tasks
Brain mapping with stimulation
Sponsored by
The University of Texas Health Science Center, Houston
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Focal Epilepsy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The University of Texas Health Science Center at HoustonRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Breathing tasks and Brain mapping with stimulation

Arm Description

Outcomes

Primary Outcome Measures

Change in percentage of breathing node size as assessed by electroencephalogram (EEG) signal
Change in presence of breathing nodes as assessed by EEG signal
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.
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.
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.
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.

Secondary Outcome Measures

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).
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).
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).

Full Information

First Posted
July 21, 2023
Last Updated
September 7, 2023
Sponsor
The University of Texas Health Science Center, Houston
Collaborators
National Institute of Neurological Disorders and Stroke (NINDS)
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1. Study Identification

Unique Protocol Identification Number
NCT05981755
Brief Title
Breathing Rescue for SUDEP Prevention
Acronym
BreatheS
Official Title
Breathing Rescue for SUDEP Prevention (BreatheS)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 31, 2023 (Actual)
Primary Completion Date
June 30, 2028 (Anticipated)
Study Completion Date
June 30, 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Texas Health Science Center, Houston
Collaborators
National Institute of Neurological Disorders and Stroke (NINDS)

4. Oversight

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

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Focal Epilepsy

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Breathing tasks and Brain mapping with stimulation
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Breathing tasks
Intervention Description
Breathing tasks include normal breathing through nose or mouth, breathing while resting wakefully, increase and decrease in breathing rate, and breath counting.
Intervention Type
Device
Intervention Name(s)
Brain mapping with stimulation
Intervention Description
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.
Primary Outcome Measure Information:
Title
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)
Title
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)
Title
Changes in thoracoabdominal circumference during stimulation as assessed by thoracoabdominal belts,
Description
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.
Time Frame
Baseline, during the stimulation session (at least 2 hours after baseline)
Title
Changes airflow during stimulation as assessed by the nasal/oral pressure transducer [BiNAPS]
Description
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.
Time Frame
Baseline, during the stimulation session (at least 2 hours after baseline)
Title
Change in Saturation of peripheral oxygen (SpO2) during stimulation as assessed by the pulse oximetry
Description
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.
Time Frame
Baseline, during the stimulation session (at least 2 hours after baseline)
Title
Change in end tidal carbon dioxide (CO2) during stimulation
Description
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.
Time Frame
Baseline, during the stimulation session (at least 2 hours after baseline)
Secondary Outcome Measure Information:
Title
Quantification of the breathing changes as assessed by the change in breathing rate
Description
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).
Time Frame
baseline (before stimulation), at the time of stimulation (about 8 minutes after start of baseline)
Title
Quantification of the breathing changes as assessed by the change in breathing depth
Description
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).
Time Frame
baseline (before stimulation), at the time of stimulation (about 8 minutes after start of baseline)
Title
Quantification of the breathing changes as assessed by the change in breathing minute ventilation (MV)
Description
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).
Time Frame
baseline (before stimulation), at the time of stimulation (about 8 minutes after start of baseline)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nuria L Lecumberri, MD,PhD
Phone
713-500-7785
Email
Nuria.Lacuey@uth.tmc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Jaison Hampson
Phone
713-500-7754
Email
Jaison.S.Hampson@uth.tmc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nuria L Lecumberri, MD,PhD
Organizational Affiliation
The University of Texas Health Science Center, Houston
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Texas Health Science Center at Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nuria L Lecumberri, MD,PhD
Phone
713-500-7785
Email
Nuria.Lacuey@uth.tmc.edu
First Name & Middle Initial & Last Name & Degree
Jaison Hampson
Phone
713-500-7754
Email
Jaison.S.Hampson@uth.tmc.edu

12. IPD Sharing Statement

Plan to Share IPD
No

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Breathing Rescue for SUDEP Prevention

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