Spinal Cord Stimulation to Shorten Ventilator Dependence in ARDS Patients

a study on Respiratory Distress Syndrome

Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at Los Angeles, California
Dates
study started
completion around
Principal Investigator
by Daniel Lu, MD, PhD

Description

Summary

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.

Official Title

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

Details

Stimulation will be conducted in closed-loop fashion at the start of inspiratory cycle. Signal from a chest belt will be used to synchronize stimulation with ventilator and prevent interference with ventilator (see Protection of Human Subjects). Prior to treatment stimulation, mapping will be conducted at 1 Hz with electrodes placed in locations identified to be optimal in the surgery cohort. Assessment of evoked EMG responses from respiratory muscles will be conducted. Once this electrode configuration is confirmed as effective (capable of evoking EMG activity), stimulation with this configuration will be applied for treatment.

Keywords

Respiratory Distress Syndrome, Newborn Respiratory Distress Syndrome, Transcutaneous Biopac Electrical Stimulator

Eligibility

You can join if…

Open to people ages 18 years and up

  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.

You CAN'T join if...

  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*.

Location

  • University of California, Los Angeles accepting new patients
    Los Angeles California 90095 United States

Lead Scientist at UCLA

  • Daniel Lu, MD, PhD
    Professor, Neurosurgery, Medicine. Authored (or co-authored) 100 research publications

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, Los Angeles
Links
UCLA Clinical Trials
ID
NCT05928052
Study Type
Interventional
Participants
Expecting 20 study participants
Last Updated