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Spinal Cord Stimulation to Shorten Ventilator Dependence in ARDS Patients

Recruiting

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

Who can join

Ages 18 and older · All sexes

Full 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\*.

About the study

This is an early phase, proof-of-concept clinical trial assessing the safety and feasibility of non-invasive spinal cord stimulation to prevent respiratory muscle atrophy in mechanically ventilated ARDS patients. The investigators will recruit 10 elective surgery patients (surgery cohort) and 10 ARDS patients (ARDS cohort) for this study. A non-invasive, alpha-prototype Restore Technology stimulator using hydrogel surface electrodes will be used to stimulate the spinal cord at the cervical or thoracic level.

What is being tested

Sponsor: University of California, Los Angeles · Participants: 20 · Started: Apr 18, 2023

Contact the study team

Official record on ClinicalTrials.gov — NCT05928052

Locations in the U.S.

CaliforniaUniversity of California, Los Angeles, Los Angeles

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.