Recruiting

Spinal Cord Stimulation

Sponsor:

UCLA

Code:

NCT05928052

Conditions

Respiratory Distress Syndrome

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Transcutaneous Biopac Electrical Stimulator

Study Details

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.

Conditions

Respiratory Distress Syndrome

Study ID

NCT05928052

Start date

Apr 18, 2023

Status verified date

Mar, 2025

Completion date

Jan 6, 2029

Anticipated

Primary completion date

Jan 6, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

20 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: ARDS cohort

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

experimental: 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

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.

Primary outcome measure

  • Recording of significant stimulation-induced adverse events (AE) [ Time Frame: 1-48 months ]

Central Contacts and Locations

Central contacts

Daniel Lu, MD, PhD

310-825-4321dclu@mednet.ucla.edu

James C Leiter, MD

603-650-6130jleiter@mednet.ucla.edu

Locations

University of California, Los Angeles

Recruiting

Los Angeles, California, United States, 90095

Contacts

Daniel C Lu, MD, PhD

310-267-2975dclu@mednet.ucla.edu

More Information

Sponsor

University of California, Los Angeles

Last update posted

Mar 10, 2025

Last verified

Mar, 2025

Keywords

  • Respiratory Distress Syndrome

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of California, Los Angeles on 2025-03-10.