Spinal Cord Stimulation to Shorten Ventilator Dependence in ARDS Patients

NCT ID: NCT05928052

Last Updated: 2025-03-10

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-18
• Study Completion Date: 2029-01-06

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.

Conditions

Respiratory Distress Syndrome

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

ARDS cohort

Patient diagnosed with ARDS. Treated daily for 60 minutes with transcutaneous cervical and/or thoracic spinal stimulation

Group Type: EXPERIMENTAL

Transcutaneous Biopac Electrical Stimulator

Intervention Type: DEVICE

A transcutaneous electrical stimulator sends low levels of electrical current through surface hydrogel electrodes directly to the spinal cord to improve function.

Surgery Cohort (Active)

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

Group Type: EXPERIMENTAL

Transcutaneous Biopac Electrical Stimulator

Intervention Type: DEVICE

A transcutaneous electrical stimulator sends low levels of electrical current through surface hydrogel electrodes directly to the spinal cord to improve function.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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*.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of California, Los Angeles

OTHER

Sponsor Role: lead

Responsible Party

Daniel Lu, MD, PhD

Professor, Neurosurgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Daniel Lu, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of California, Los Angeles

Locations

University of California, Los Angeles

Los Angeles, California, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Daniel Lu, MD, PhD

Role: CONTACT

dclu@mednet.ucla.edu

310-825-4321

James C Leiter, MD

Role: CONTACT

jleiter@mednet.ucla.edu

603-650-6130

Facility Contacts

Daniel C Lu, MD, PhD

Role: primary

dclu@mednet.ucla.edu

310-267-2975

Related Links

https://www.uclahealth.org/clinical-trials

UCLA Clinical Trials

Other Identifiers

21-001220

Identifier Type: -

Identifier Source: org_study_id