Spinal Cord Stimulation to Shorten Ventilator Dependence in ARDS Patients

Not Applicable

Recruiting

• Conditions: Respiratory Distress Syndrome
• Interventions: Device: Transcutaneous Biopac Electrical Stimulator

• Registration Number: NCT05928052
• Lead Sponsor: University of California, Los Angeles

Brief 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.

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.

Study Timeline

• Study Start: 2023-04-18
• Study First Submitted: 2023-05-23
• Study First Submitted QC: 2023-06-22
• Study First Posted: 2023-07-03
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-07
• Last Update Posted: 2025-03-10
• Primary Completion: 2027-01-06
• Study Completion: 2029-01-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

Inclusion 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.

Exclusion Criteria

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*.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Surgery Cohort (Active)	Transcutaneous Biopac Electrical Stimulator	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
ARDS cohort	Transcutaneous Biopac Electrical Stimulator	Patient diagnosed with ARDS. Treated daily for 60 minutes with transcutaneous cervical and/or thoracic spinal stimulation

Primary Outcome Measures

Name	Time	Method
Recording of significant stimulation-induced adverse events (AE)	1-48 months	Although unlikely, we will record and monitor the number of stimulation-induced adverse events per case and per cohort. Our goal is to have an overall AE rate of less than 10% per cohort.

Secondary Outcome Measures

Name	Time	Method
Measurement of respiratory pressure	1-48 months	Peak Inspiratory and Expiratory pressure measurements (in mm Hg) will be recorded from ventilation units to determine if stimulation maintains or improves respiratory airway pressure.
Recording of total ventilation time	1-48 months	The total time that patient is ventilated will be recorded to determine if stimulation reduces total intubation time
Assessment of respiratory tidal volume	1-48 months	Respiratory Tidal Volume (voluntary and resting) will be recorded (in mL) to determine if stimulation assists in maintaining or improving lung capacity.
Measurement of diaphragm thickness	1-48 months	Evidence of maintenance of diaphragm muscle thickness (in mm) by ultrasound
Measurement of ventilator weaning time	1-48 months	Measurements of ventilator weaning time will be recorded to determine if stimulation assists in decreasing the total time from complete intubation to complete extubation.
Assessment of diaphragm and respiratory muscle EMG amplitudes	1-48 months	EMG amplitudes of diaphragm and other muscles involved in respiration (intercostals, trapezius, abdominal) will be measured at a couple time points throughout the study period to determine if stimulation can maintain muscle response.

Trial Locations

Locations (1)

University of California, Los Angeles; 🇺🇸 Los Angeles, California, United States