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Recruiting NCT05928052

Spinal Cord Stimulation to Shorten Ventilator Dependence in ARDS Patients

No phase Interventional Respiratory Distress Syndrome

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Transcutaneous Biopac Electrical Stimulator.
Who it may be relevant to
Registry conditions: Respiratory Distress Syndrome. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

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.

Detailed description

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.

Interventions

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

Primary outcome measures

  • Recording of significant stimulation-induced adverse events (AE) [Time frame: 1-48 months]
Secondary outcome measures (6)
  • Recording of total ventilation time [Time frame: 1-48 months]
  • Measurement of diaphragm thickness [Time frame: 1-48 months]
  • Assessment of diaphragm and respiratory muscle EMG amplitudes [Time frame: 1-48 months]
  • Measurement of respiratory pressure [Time frame: 1-48 months]
  • Assessment of respiratory tidal volume [Time frame: 1-48 months]
  • Measurement of ventilator weaning time [Time frame: 1-48 months]

Eligibility criteria

Inclusion criteria

  • Male or female 18-85 years;
  • 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;
  • Able to provide informed consent or available next of kin able to provide informed consent;
  • Have intact chest/lung, upper and lower extremity anatomy;
  • The neuromuscular connections between the spinal cord, diaphragm, and intercostal muscles are intact;
  • Enrollment of subject within 48 hours of intubation;
  • Able to induce evoked response of diaphragm muscle by spinal cord TES.

Exclusion criteria

  • Phrenic nerve or diaphragm pacer;
  • History of seizure disorder or on anti-epileptic medication for the treatment of seizures;
  • Compromised skin in back (neck, upper and lower back);
  • Pregnancy;
  • Implanted devices: cardiac pacemakers, implanted defibrillators, implanted neurostimulators, phrenic nerve pacers;
  • BMI greater than or equal to 35;
  • Pharmacological paralysis/neuromuscular blockade\*.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Prevention

Study locations

United States · 1 center
  • University of California, Los Angeles — Los Angeles

Identifiers

NCT: NCT05928052 · 21-001220

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗