Non-Invasive Spinal Cord Stimulation for Respiratory Distress Syndrome

Overseen by Daniel C Lu, MD, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of California, Los Angeles

Must not be taking: Anti-epileptics

Disqualifiers: Seizure disorder, Pregnancy, BMI ≥ 35, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial is testing a device that sends small electrical signals to the spinal cord to keep breathing muscles strong in patients who need help breathing from machines. It targets patients with ARDS and those having elective surgery.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but if you are on anti-epileptic medication for seizures, you cannot participate.

What data supports the effectiveness of the treatment Transcutaneous Biopac Electrical Stimulator for Respiratory Distress Syndrome?

Research shows that transcutaneous electrical spinal cord stimulation can influence vital functions like respiratory and cardiovascular systems, suggesting potential benefits for conditions like Respiratory Distress Syndrome. ^{1 2 3 4 5}

Is non-invasive spinal cord stimulation generally safe for humans?

Transcutaneous spinal direct current stimulation (tsDCS), a type of non-invasive spinal cord stimulation, is considered a new and safe technique for modulating spinal cord activity. ^{1 5 6 7 8}

How does non-invasive spinal cord stimulation differ from other treatments for respiratory distress syndrome?

Non-invasive spinal cord stimulation is unique because it uses direct current through skin electrodes to improve motor and autonomic functions, which may help with respiratory distress by enhancing spinal cord activity without surgery or drugs. This approach is different from traditional treatments that might rely on medication or invasive procedures. ^{8 9 10 11 12}

Research Team

Daniel C Lu, MD, PhD

Principal Investigator

University of California, Los Angeles

Eligibility Criteria

This trial is for ICU patients aged 18-85 who've had non-cardiac surgery or have ARDS, can consent (or their kin can), and were intubated within the last 48 hours. They must be able to respond to spinal cord stimulation with intact anatomy and connections between the spinal cord and respiratory muscles. Excluded are those with seizure histories, skin issues on the back, certain implants, a BMI of 35 or higher, or pregnancy.

Inclusion Criteria

Able to provide informed consent or available next of kin able to provide informed consent

My diaphragm muscle responds to spinal cord stimulation.

I was put on a breathing machine within the last 2 days.

Exclusion Criteria

You have a phrenic nerve or diaphragm pacer.

I have skin issues on my neck or back.

I have a history of seizures or am on medication for seizures.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Daily transcutaneous spinal cord stimulation for 60 minutes to improve respiratory function in ARDS and surgery cohorts

4-8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

48 months

Treatment Details

Interventions

• Transcutaneous Biopac Electrical Stimulator (Procedure)

Trial Overview The study tests a non-invasive electrical stimulator on two groups: post-surgery patients and ARDS sufferers. It aims to prevent muscle weakening from long ventilator use by stimulating the spinal cord at specific points using surface electrodes.

Participant Groups

Group I: Surgery Cohort (Active) Experimental Treatment 1 Intervention

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 II: ARDS cohort Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

University of California, Los Angeles

Lead Sponsor

Trials

1,594

Recruited

10,430,000+

Dr. Thomas Rando

University of California, Los Angeles

Chief Medical Officer since 2023

MD from UCLA

Amir Naiberg

University of California, Los Angeles

Chief Executive Officer since 2024

JD from UCLA

Findings from Research

Transcutaneous electrical spinal cord stimulation is being explored for both experimental studies and rehabilitation in patients with spinal cord injuries, highlighting its potential to enhance motor function.

This method not only targets motor functions but also influences vital systems such as cardiovascular, respiratory, and digestive functions, indicating a broader impact on overall health during rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Mehanisms of Influences of Electrical Spinal Cord Stimulation on Autonomic Functions.] Moshonkina, TR., Stolbkov, YK., Kozlovskaya, IB., et al.[2019]

In a pilot study involving 7 individuals with chronic spinal cord injury, the use of transcutaneous electrical spinal cord stimulation (TSCS) combined with functional training led to improvements in upper and lower extremity function, with all participants showing progress on the Capabilities of Upper Extremity Test (CUE-T).

Notably, two participants improved their ASIA impairment scale classification, and five individuals experienced enhanced sensation, demonstrating that TSCS can facilitate recovery even after a plateau in rehabilitation progress, without any serious adverse events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcutaneous Electrical Spinal Cord Stimulation to Promote Recovery in Chronic Spinal Cord Injury. Tefertiller, C., Rozwod, M., VandeGriend, E., et al.[2022]

In a study of 19 patients with diabetic foot, spinal cord electrical stimulator implantation significantly reduced pain levels and improved quality of life, as indicated by lower visual analog scale scores and higher QOL scores post-surgery.

The procedure also enhanced nerve conduction velocities and increased blood flow to the lower limbs, achieving a high limb salvage rate of 94.74%, suggesting it is an effective treatment option for preventing toe amputation in diabetic foot patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical Effect Analysis of Spinal Cord Electrical Stimulator Implantation for Diabetic Foot. Zhou, PB., Bao, M.[2023]

In a study of 149 patients with spinal cord stimulators, changing body positions significantly affected stimulation thresholds, with constant-current stimulators showing a greater increase in thresholds (44% to 82%) compared to constant-voltage stimulators (22% to 34%).

Postural changes from lying to sitting or standing often led to discomfort, especially with constant-current stimulators, indicating that patient positioning is crucial for optimizing spinal cord stimulation therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Postural Changes in Spinal Cord Stimulation Thresholds: Current and Voltage Sources. North, RB., Sung, JH., Matthews, LA., et al.[2023]

Transcutaneous spinal direct current stimulation (tsDCS) is a safe technique that can effectively modulate spinal cord excitability, as shown by changes in motor-evoked potentials (MEPs) in healthy subjects after stimulation.

The study found that cathodal tsDCS increased MEP amplitudes indicating enhanced inhibitory GABA(A)ergic drive, while anodal tsDCS had the opposite effect, suggesting tsDCS could be a promising rehabilitation strategy for patients with acute brain lesions or spinal diseases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Spinal Direct Current Stimulation Modulates Short Intracortical Inhibition. Bocci, T., Barloscio, D., Vergari, M., et al.[2022]

In a study of 68 patients who had spinal cord stimulation paddle electrodes removed, the most common reason for removal was loss of coverage or effect (75%), indicating that while SCS is effective, it may not always provide lasting relief.

Postoperative complications occurred in 11.75% of patients, with two major complications requiring reoperation, highlighting that while SCS removal is generally safe, it does carry some risks that patients should be aware of.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rate of Complications Following Spinal Cord Stimulation Paddle Electrode Removal. Maldonado-Naranjo, AL., Frizon, LA., Sabharwal, NC., et al.[2022]

In a pilot study involving 20 patients with idiopathic Restless Legs Syndrome (RLS) and 14 healthy subjects, transcutaneous spinal direct current stimulation (tsDCS) was shown to reduce symptoms of RLS, indicating its potential as a non-invasive treatment option.

Anodal stimulation specifically decreased spinal excitability, as measured by the H2/H1-ratio, and led to significant reductions in RLS symptoms, while sham stimulation had no effect, supporting the idea that spinal cord hyperexcitability contributes to RLS.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of transcutaneous spinal direct current stimulation in idiopathic restless legs patients. Heide, AC., Winkler, T., Helms, HJ., et al.[2018]

Transdermal micropolarization using local direct current in patients with spinal cord injuries or tuberculous spondylitis led to significant improvements in both motor and autonomic functions.

The treatment positively affected the spinal cord's condition and cardiac activity, suggesting that direct current may enhance recovery in spinal cord damage cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[The use micro-polarization in spinal cord lesions]. Sheliakin, AM., Preobrazhenskaia, IG., Komantsev, VN., et al.[2016]

The novel closed-loop spinal cord stimulation (SCS) system effectively reduced pain intensity in patients with chronic pain, showing significant decreases from a baseline score of 8.4 to 2.0 after 12 months, with 85% patient satisfaction reported.

This real-world study involving 22 patients supports the efficacy of the ECAP-controlled SCS system, maintaining pain relief comparable to results from previous clinical trials, indicating its potential as a reliable treatment option for persistent spinal pain syndrome.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

First Report on Real-World Outcomes with Evoked Compound Action Potential (ECAP)-Controlled Closed-Loop Spinal Cord Stimulation for Treatment of Chronic Pain. Nijhuis, HJA., Hofsté, WJ., Krabbenbos, IP., et al.[2023]

Percutaneous spinal cord epidural stimulation (SCES) allowed two individuals with chronic complete spinal cord injuries to achieve voluntary muscle activation and movement below their injury level, demonstrating its potential for motor control restoration.

One participant was able to stand independently and walk with minimal assistance just one day after temporary SCES implantation, highlighting the rapid benefits of this intervention for rehabilitation in spinal cord injury patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A case study of percutaneous epidural stimulation to enable motor control in two men after spinal cord injury. Gorgey, AS., Trainer, R., Sutor, TW., et al.[2023]

Transdermal micropolarization using local direct currents improved motor and autonomic functions in patients with spinal cord trauma and tuberculous spondylitis, indicating its potential as a therapeutic intervention.

The study monitored clinical and electrophysiological changes, suggesting that direct currents can positively affect the functional state of the spinal cord and heart activity, highlighting the mechanism of action for this treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The use of micropolarization in the treatment of spinal cord lesions. Shelyakin, AM., Preobrazhenskaya, IG., Komantsev, VN., et al.[2019]

References

1. Saudi Arabia pubmed.ncbi.nlm.nih.gov

Spinal direct current stimulation with locomotor training in chronic spinal cord injury. [2021]

2. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[Mehanisms of Influences of Electrical Spinal Cord Stimulation on Autonomic Functions.] [2019]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Transcutaneous Electrical Spinal Cord Stimulation to Promote Recovery in Chronic Spinal Cord Injury. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Clinical Effect Analysis of Spinal Cord Electrical Stimulator Implantation for Diabetic Foot. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Postural Changes in Spinal Cord Stimulation Thresholds: Current and Voltage Sources. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Spinal Direct Current Stimulation Modulates Short Intracortical Inhibition. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Rate of Complications Following Spinal Cord Stimulation Paddle Electrode Removal. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Effects of transcutaneous spinal direct current stimulation in idiopathic restless legs patients. [2018]

9. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[The use micro-polarization in spinal cord lesions]. [2016]

10. New Zealand pubmed.ncbi.nlm.nih.gov

First Report on Real-World Outcomes with Evoked Compound Action Potential (ECAP)-Controlled Closed-Loop Spinal Cord Stimulation for Treatment of Chronic Pain. [2023]

11. England pubmed.ncbi.nlm.nih.gov

A case study of percutaneous epidural stimulation to enable motor control in two men after spinal cord injury. [2023]

12. United States pubmed.ncbi.nlm.nih.gov

The use of micropolarization in the treatment of spinal cord lesions. [2019]