RECRUITING

Spinal Cord Stimulation to Shorten Ventilator Dependence in ARDS Patients

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Conditions

Respiratory Distress Syndrome

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2022-01-07
Study Completion:2029-01-06
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05928052

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Male or female 18-85 years;
  2. 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. 3. Able to provide informed consent or available next of kin able to provide informed consent;
  4. 4. Have intact chest/lung, upper and lower extremity anatomy;
  5. 5. The neuromuscular connections between the spinal cord, diaphragm, and intercostal muscles are intact;
  6. 6. Enrollment of subject within 48 hours of intubation;
  7. 7. Able to induce evoked response of diaphragm muscle by spinal cord TES.
  1. 1. Phrenic nerve or diaphragm pacer;
  2. 2. History of seizure disorder or on anti-epileptic medication for the treatment of seizures;
  3. 3. Compromised skin in back (neck, upper and lower back);
  4. 4. Pregnancy;
  5. 5. Implanted devices: cardiac pacemakers, implanted defibrillators, implanted neurostimulators, phrenic nerve pacers;
  6. 6. BMI greater than or equal to 35;
  7. 7. Pharmacological paralysis/neuromuscular blockade\*.

Contacts and Locations

Study Contact

Daniel Lu, MD, PhD
CONTACT
310-825-4321
dclu@mednet.ucla.edu
James C Leiter, MD
CONTACT
603-650-6130
jleiter@mednet.ucla.edu

Principal Investigator

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

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: University of California, Los Angeles

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-01-07
Study Completion Date2029-01-06

Study Record Updates

Study Start Date2022-01-07
Study Completion Date2029-01-06

Terms related to this study

Keywords Provided by Researchers

  • Respiratory Distress Syndrome

Additional Relevant MeSH Terms

  • Respiratory Distress Syndrome