NCT05928052

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
32mo left

Started Apr 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress54%
Apr 2023Jan 2029

Study Start

First participant enrolled

April 18, 2023

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 23, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 3, 2023

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 6, 2027

Expected
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 6, 2029

Last Updated

March 10, 2025

Status Verified

March 1, 2025

Enrollment Period

3.7 years

First QC Date

May 23, 2023

Last Update Submit

March 7, 2025

Conditions

Respiratory Distress Syndrome

Keywords

Respiratory Distress Syndrome

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • Recording of total ventilation time

    1-48 months

  • Measurement of diaphragm thickness

    1-48 months

  • Assessment of diaphragm and respiratory muscle EMG amplitudes

    1-48 months

  • Measurement of respiratory pressure

    1-48 months

  • Assessment of respiratory tidal volume

    1-48 months

  • +1 more secondary outcomes

Study Arms (2)

ARDS cohort

EXPERIMENTAL

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

Device: Transcutaneous Biopac Electrical Stimulator

Surgery Cohort (Active)

EXPERIMENTAL

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

Device: Transcutaneous Biopac Electrical Stimulator

Interventions

Transcutaneous Biopac Electrical StimulatorDEVICE

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

ARDS cohortSurgery Cohort (Active)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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\*.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California, Los Angeles

Los Angeles, California, 90095, United States

RECRUITING

Related Links

MeSH Terms

Conditions

Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesRespiration Disorders

Study Officials

  • Daniel Lu, MD, PhD

    University of California, Los Angeles

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Daniel Lu, MD, PhD

CONTACT

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

James C Leiter, MD

CONTACT

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, Neurosurgery

Study Record Dates

First Submitted

May 23, 2023

First Posted

July 3, 2023

Study Start

April 18, 2023

Primary Completion (Estimated)

January 6, 2027

Study Completion (Estimated)

January 6, 2029

Last Updated

March 10, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)