Health TrialsbyHealthPanel

Breathing Rescue for SUDEP Prevention

ConditionFocal Epilepsy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorThe University of Texas Health Science Center, Houston

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

respiratory, cardiac or cerebrovascular disease

pregnancy

prisoners

Trial design

Design model

Single group

Treatments tested in this trial

  • Breathing tasks

    Other intervention

    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 stimulation

    Device

    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.

Treatment groups

100 Participants
are divided into 1 treatment group
Group A: Breathing tasks and Brain mapping with stimulationExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

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,

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)
4

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.

Time frame
Baseline, during the stimulation session (at least 2 hours after baseline)

Secondary outcomes

1

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).

Time frame
baseline (before stimulation), at the time of stimulation (about 8 minutes after start of baseline)
2

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).

Time frame
baseline (before stimulation), at the time of stimulation (about 8 minutes after start of baseline)
3

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).

Time frame
baseline (before stimulation), at the time of stimulation (about 8 minutes after start of baseline)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

The University of Texas Health Science Center, Houston

Lead sponsor

National Institute of Neurological Disorders and Stroke (NINDS)

Collaborator

Source ClinicalTrials.gov
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