Actively Recruiting
Spinal Cord Stimulation to Shorten Ventilator Dependence in ARDS Patients
Led by University of California, Los Angeles · Updated on 2025-03-10
20
Participants Needed
1
Research Sites
298 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Spinal Cord Stimulation to Shorten Ventilator Dependence in ARDS Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged 18 to 85 years
- Intubated with confirmed diagnosis of ARDS based on Berlin Criteria or admitted to ICU after non-cardiac surgery
- Able to provide informed consent or have a next of kin who can provide consent
- Intact chest/lung and upper and lower extremity anatomy
- Neuromuscular connections between spinal cord, diaphragm, and intercostal muscles intact
- Enrollment within 48 hours of intubation
- Able to induce evoked diaphragm muscle response by spinal cord transcutaneous electrical stimulation
You will not qualify if you...
- Use of phrenic nerve or diaphragm pacer
- History of seizure disorder or currently on anti-epileptic medication
- Compromised skin on neck, upper or lower back
- Pregnancy
- Presence of implanted devices such as cardiac pacemakers, defibrillators, neurostimulators, or phrenic nerve pacers
- Body mass index (BMI) of 35 or higher
- Receiving pharmacological paralysis or neuromuscular blockade
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
University of California, Los Angeles
Los Angeles, California, United States, 90095
Actively Recruiting
Research Team
D
Daniel Lu, MD, PhD
CONTACT
J
James C Leiter, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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