Respiratory Distress SyndromeNCT05928052
Spinal Cord Stimulation to Shorten Ventilator Dependence in ARDS Patients
A study testing Transcutaneous Biopac Electrical Stimulator in people with Respiratory Distress Syndrome, run by University of California, Los Angeles at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Respiratory Distress Syndrome
- What is being tested?
- Transcutaneous Biopac Electrical Stimulator
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Apr 2023to 6 Jan 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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*.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of California, Los Angeles
Los Angeles, California, 90095
Daniel C Lu, MD, PhD, 310-267-2975, dclu@mednet.ucla.edu
About this study
Official title: Transcutaneous Spinal Cord Stimulation to Improve Respiratory Function and Shorten Ventilator Dependence in Patients with ARDS
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.
Read the 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
- Being tested
- Transcutaneous Biopac Electrical Stimulator
- Keywords
- Respiratory Distress Syndrome
- Medical subject headings
- Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| ARDS cohort | Experimental | Patient diagnosed with ARDS. Treated daily for 60 minutes with transcutaneous cervical and/or thoracic spinal stimulation Receives: 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 Receives: Device: Transcutaneous Biopac Electrical Stimulator |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1-48 months
Secondary outcomes (6)
Recording of total ventilation time
The total time that patient is ventilated will be recorded to determine if stimulation reduces total intubation time
Measured: 1-48 months
Measurement of diaphragm thickness
Evidence of maintenance of diaphragm muscle thickness (in mm) by ultrasound
Measured: 1-48 months
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.
Measured: 1-48 months
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.
Measured: 1-48 months
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.
Measured: 1-48 months
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.
Measured: 1-48 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2023
- Study start18 Apr 2023
- Primary completion6 Jan 2027 (estimated)
- Study completion6 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Distress SyndromeStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniel Lu, MD, PhD, University of California, Los Angeles
- Investigators
- Daniel Lu, MD, PhD, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05928052
- Sponsor's protocol ID
- 21-001220
- Status last verified
- Mar 2025
- First submitted
- 23 May 2023
- Last updated
- 10 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcutaneous Spinal Cord Stimulation to Improve Respiratory Function and Shorten Ventilator Dependence in Patients with ARDS
- ClinicalTrials.gov ID
- NCT05928052
- Acronym / sponsor ID
- 21-001220
- Conditions
- Respiratory Distress Syndrome
- Keywords
- Respiratory Distress Syndrome
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Study start
- 18 Apr 2023 (actual)
- Primary completion
- 6 Jan 2027 (estimated)
- Study completion
- 6 Jan 2029 (estimated)
- First posted
- 3 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ARDS cohort | Experimental | Device: Transcutaneous Biopac Electrical StimulatorPatient diagnosed with ARDS. Treated daily for 60 minutes with transcutaneous cervical and/or thoracic spinal stimulation |
| Surgery Cohort (Active) | Experimental | Device: Transcutaneous Biopac Electrical StimulatorPatient 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcutaneous Biopac Electrical StimulatorA transcutaneous electrical stimulator sends low levels of electrical current through surface hydrogel electrodes directly to the spinal cord to improve function. | Device | ARDS cohort, Surgery Cohort (Active) |
Primary outcome
Recording of significant stimulation-induced adverse events (AE)
Time frame: 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.
6 secondary outcomes
Recording of total ventilation time
Time frame: 1-48 months
Measurement of diaphragm thickness
Time frame: 1-48 months
Assessment of diaphragm and respiratory muscle EMG amplitudes
Time frame: 1-48 months
Measurement of respiratory pressure
Time frame: 1-48 months
Assessment of respiratory tidal volume
Time frame: 1-48 months
Measurement of ventilator weaning time
Time frame: 1-48 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2025.
- UCLA Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Daniel Lu, MD, PhD principal investigator
University of California, Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcutaneous Biopac Electrical Stimulator in people with Respiratory Distress Syndrome, run by University of California, Los Angeles at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Daniel Lu, MD, PhD (310-825-4321, dclu@mednet.ucla.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recording of significant stimulation-induced adverse events (AE) (time frame: 1-48 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2025.