Spinal Cord Stimulation to Shorten Ventilator Dependence in ARDS Patients

Respiratory Distress Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05928052
• Other study ID #: 21-001220
• Status: Recruiting
• Phase: N/A
• Start date: January 7, 2022
• Est. completion date: January 6, 2029

Study information

• Verified date: June 2023
• Source: University of California, Los Angeles
• Contact: Daniel Lu, MD, PhD
• Phone: 310-825-4321
• Email: dclu[@]mednet.ucla.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: January 6, 2029
• Est. primary completion date: January 6, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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*.

Related Conditions & MeSH terms

• Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Newborn

Intervention

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.

Locations

Country	Name	City	State
United States	University of California, Los Angeles	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Los Angeles

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recording of significant stimulation-induced adverse events (AE)	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.	1-48 months
Secondary	Recording of total ventilation time	The total time that patient is ventilated will be recorded to determine if stimulation reduces total intubation time	1-48 months
Secondary	Measurement of diaphragm thickness	Evidence of maintenance of diaphragm muscle thickness (in mm) by ultrasound	1-48 months
Secondary	Assessment of diaphragm and respiratory muscle EMG amplitudes	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.	1-48 months
Secondary	Measurement of respiratory pressure	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.	1-48 months
Secondary	Assessment of respiratory tidal volume	Respiratory Tidal Volume (voluntary and resting) will be recorded (in mL) to determine if stimulation assists in maintaining or improving lung capacity.	1-48 months
Secondary	Measurement of ventilator weaning time	Measurements of ventilator weaning time will be recorded to determine if stimulation assists in decreasing the total time from complete intubation to complete extubation.	1-48 months

External Links

•   UCLA Clinical Trials