Spinal Cord Stimulation to Shorten Ventilator Dependence in ARDS Patients

Part of paid clinical trials in Los Angeles, California.

Sponsor
University of California, Los Angeles
Study ID
NCT05928052
Status
Recruiting
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Conditions

  • Respiratory Distress Syndrome

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Transcutaneous Biopac Electrical Stimulator — DEVICE
    A transcutaneous electrical stimulator sends low levels of electrical current through surface hydrogel electrodes directly to the spinal cord to improve function.

Study Details

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.

Key Dates

Start date
Apr 18, 2023
Status verified
Mar 2025
Primary completion
Jan 6, 2027
Completion
Jan 6, 2029

Study Design

Enrollment
20 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: ARDS cohort
    Patient diagnosed with ARDS. Treated daily for 60 minutes with transcutaneous cervical and/or thoracic spinal stimulation
  • Experimental: Surgery Cohort (Active)
    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

Primary Outcome Measure

Recording of significant stimulation-induced adverse events (AE) [ Time Frame: 1-48 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of California, Los AngelesLos AngelesCalifornia90095
Daniel C Lu, MD, PhD
[email protected]
310-267-2975

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By research site
University of California, Los Angeles· Los Angeles, CA

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