Using spinal cord stimulation to reduce ventilator dependence in ARDS patients

Transcutaneous Spinal Cord Stimulation to Improve Respiratory Function and Shorten Ventilator Dependence in Patients with ARDS

This study is testing if a new non-invasive spinal cord stimulation can help patients with Acute Respiratory Distress Syndrome who are on ventilators keep their breathing muscles strong and reduce their dependence on the machine.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University of California, Los Angeles (Academic / other)
• Locations: 1 site (Los Angeles, California)
• Trial ID: NCT05928052 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the safety and feasibility of non-invasive spinal cord stimulation to prevent respiratory muscle atrophy in patients with Acute Respiratory Distress Syndrome (ARDS) who are on mechanical ventilation. The study will recruit 20 participants, including 10 elective surgery patients and 10 ARDS patients, using a prototype stimulator with hydrogel electrodes to stimulate the spinal cord. Stimulation will be synchronized with the ventilator to ensure effective treatment while avoiding interference. The trial aims to assess the evoked EMG responses from respiratory muscles to confirm the effectiveness of the stimulation configuration before applying it for treatment.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-85 who are intubated with a confirmed diagnosis of ARDS and can provide informed consent.

Not a fit: Patients with phrenic nerve or diaphragm pacers, or those with a history of seizure disorders may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly shorten the duration of ventilator dependence for ARDS patients, improving recovery outcomes.

How similar studies have performed: While this approach is innovative, similar studies using spinal cord stimulation for respiratory support have shown promise, indicating potential for success.

Eligibility criteria

Inclusion Criteria:

1. Male or female 18-85 years;
2. Intubated with confirmed diagnosis of ARDS (by Berlin Criteria: acute onset within one week of known insult, bilateral airspace opacities not fully explained by pleural effusions, atelectasis, and/or nodules, respiratory failure not explained by heart failure or fluid overload, PaO2/FiO2 ratio \< 300); or identified as a patient admitted to the intensive care unit (ICU) after non-cardiac surgery;
3. Able to provide informed consent or available next of kin able to provide informed consent;
4. Have intact chest/lung, upper and lower extremity anatomy;
5. The neuromuscular connections between the spinal cord, diaphragm, and intercostal muscles are intact;
6. Enrollment of subject within 48 hours of intubation;
7. Able to induce evoked response of diaphragm muscle by spinal cord TES.

Exclusion Criteria:

1. Phrenic nerve or diaphragm pacer;
2. History of seizure disorder or on anti-epileptic medication for the treatment of seizures;
3. Compromised skin in back (neck, upper and lower back);
4. Pregnancy;
5. Implanted devices: cardiac pacemakers, implanted defibrillators, implanted neurostimulators, phrenic nerve pacers;
6. BMI greater than or equal to 35;
7. Pharmacological paralysis/neuromuscular blockade\*.

Where this trial is running

Los Angeles, California

• University of California, Los Angeles — Los Angeles, California, United States (Recruiting)

Study contacts

• Principal investigator: Daniel Lu, MD, PhD — University of California, Los Angeles
• Study coordinator: Daniel Lu, MD, PhD

Conditions Respiratory Distress Syndrome