Spinal Cord Stimulation to Shorten Ventilator Dependence in ARDS Patients

Description

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

Respiratory Distress Syndrome

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Study Overview

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Study Details

Study overview

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.

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

Spinal Cord Stimulation to Shorten Ventilator Dependence in ARDS Patients

Condition
Respiratory Distress Syndrome
Intervention / Treatment

-

Contacts and Locations

Los Angeles

University of California, Los Angeles, Los Angeles, California, United States, 90095

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • 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\*.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

University of California, Los Angeles,

Daniel Lu, MD, PhD, PRINCIPAL_INVESTIGATOR, University of California, Los Angeles

Study Record Dates

2029-01-06