What side effects are associated with this type of intervention?

Common treatments for Respiratory Distress Syndrome (RDS) such as neuromuscular blockade (NMB) and phrenic nerve stimulation have known side effects. NMB can lead to prolonged neuromuscular weakness, while phrenic nerve stimulation may cause potential nerve damage and complications related to electrode placement. These treatments aim to improve respiratory function but come with risks that need to be carefully managed.

What prior FDA approvals exist?

FDA-approved treatments for Respiratory Distress Syndrome (RDS) primarily include surfactant replacement therapy, which helps reduce the surface tension in the lungs and improve oxygenation. While non-invasive spinal cord stimulation is a novel approach being studied to maintain or enhance respiratory muscle function, there are no specific FDA-approved drugs or devices for RDS that use this method. Current treatments focus on mechanical ventilation, supportive care, and pharmacotherapy to manage symptoms and improve patient outcomes.

What other types of research exist?

Promising novel alternatives to non-invasive spinal cord stimulation for ARDS patients include: 1) Neuromuscular Blockade (NMB) with agents like cisatracurium besylate, which may improve oxygenation but should be used cautiously due to potential prolonged neuromuscular weakness. 2) Functional Electrical Stimulation (FES) of the abdominal muscles to enhance cough and assist in respiratory function. 3) Diaphragm Pacing, which involves stimulating the phrenic nerve to maintain diaphragm function and reduce ventilator dependence. Each of these alternatives has shown potential in improving respiratory outcomes in specific patient populations.

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Non-Invasive Spinal Cord Stimulation for Respiratory Distress Syndrome

N/A

Recruiting

Led By Daniel Lu, MD, PhD

Research Sponsored by University of California, Los Angeles

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Able to induce evoked response of diaphragm muscle by spinal cord TES

Enrollment of subject within 48 hours of intubation

Must not have

Compromised skin in back (neck, upper and lower back)

History of seizure disorder or on anti-epileptic medication for the treatment of seizures

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1-48 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a device that sends small electrical signals to the spinal cord to keep breathing muscles strong in patients who need help breathing from machines. It targets patients with ARDS and those having elective surgery.

Who is the study for?

This trial is for ICU patients aged 18-85 who've had non-cardiac surgery or have ARDS, can consent (or their kin can), and were intubated within the last 48 hours. They must be able to respond to spinal cord stimulation with intact anatomy and connections between the spinal cord and respiratory muscles. Excluded are those with seizure histories, skin issues on the back, certain implants, a BMI of 35 or higher, or pregnancy.

What is being tested?

The study tests a non-invasive electrical stimulator on two groups: post-surgery patients and ARDS sufferers. It aims to prevent muscle weakening from long ventilator use by stimulating the spinal cord at specific points using surface electrodes.

What are the potential side effects?

Potential side effects may include discomfort at the electrode site, unintended muscle contractions during stimulation, skin irritation from hydrogel electrodes, and in rare cases could potentially trigger seizures in susceptible individuals.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My diaphragm muscle responds to spinal cord stimulation.

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I was put on a breathing machine within the last 2 days.

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I was admitted to the ICU following a non-heart related surgery.

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My chest, arms, and legs are structurally normal.

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My nerves connecting my spinal cord to my breathing muscles are working.

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I am on a ventilator due to severe lung injury.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have skin issues on my neck or back.

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I have a history of seizures or am on medication for seizures.

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I am currently not undergoing any treatment that involves being medically paralyzed.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1-48 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1-48 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1-48 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Recording of significant stimulation-induced adverse events (AE)

Secondary study objectives

Assessment of diaphragm and respiratory muscle EMG amplitudes

Assessment of respiratory tidal volume

Measurement of diaphragm thickness

+3 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Surgery Cohort (Active)Experimental Treatment1 Intervention

Patient undergoing inpatient non-cardiac surgery admitted to the intensive care unit (ICU) after surgery. Treated daily for 60 minutes with transcutaneous cervical and/or thoracic spinal stimulation

Group II: ARDS cohortExperimental Treatment1 Intervention

Patient diagnosed with ARDS. Treated daily for 60 minutes with transcutaneous cervical and/or thoracic spinal stimulation

0 / 9Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Respiratory Distress Syndrome (RDS) include mechanical ventilation, which supports breathing by delivering oxygen and removing carbon dioxide; fluid management, which aims to maintain optimal fluid balance to prevent fluid overload in the lungs; and pharmacotherapy, which may involve the use of corticosteroids to reduce inflammation. Non-invasive spinal cord stimulation, a novel treatment being studied, works by stimulating the spinal cord to maintain or enhance respiratory muscle function, potentially preventing respiratory muscle atrophy. This is particularly important for RDS patients as it may improve their ability to breathe independently and reduce the duration of mechanical ventilation, thereby decreasing the risk of ventilator-associated complications.

Spinal cord injury and degenerative cervical myelopathy.Review of Epidural Spinal Cord Stimulation for Augmenting Cough after Spinal Cord Injury.Spinal cord stimulation: a new method to produce an effective cough in patients with spinal cord injury.