Spinal Cord Stimulation for Spinal Cord Injury

Overseen By Andrea Willhite, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Louisville

Disqualifiers: Depression, Cardiovascular, Pulmonary, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore how spinal cord stimulation can improve breathing in people with spinal cord injuries. Researchers are testing whether electrical stimulation of the spine, either alone or combined with respiratory training (breathing exercises), can activate muscle networks involved in breathing. The goal is to find the best way to enhance breathing function and potentially establish this as a standard treatment. Suitable participants have had a stable spinal cord injury, specifically in the neck or upper back, for at least two years and experience breathing difficulties. As an unphased trial, this study offers participants the chance to contribute to groundbreaking research that could lead to new treatment options for breathing difficulties.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this spinal cord stimulation is safe for respiratory rehabilitation?

A previous study examined the safety and effectiveness of epidural spinal cord stimulation (eSCS) in people with spinal cord injuries. The study found that participants generally tolerated eSCS well. Most side effects were mild and temporary, such as skin irritation at the electrode site, while serious side effects were rare.

Research on breathing exercises also supports their safety. Studies have shown no negative effects in adults with spinal cord injuries. These exercises strengthen breathing muscles without causing harm.

Current research has shown both eSCS and breathing exercises to be safe. Reports of significant side effects are few, making them promising options for those considering joining a clinical trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments for spinal cord injuries because they explore innovative ways to improve patients' quality of life. Unlike traditional rehabilitation therapies, spinal cord epidural stimulation directly activates the spinal cord, potentially restoring functions that were thought to be lost. Respiratory training focuses on enhancing breathing capabilities, which is crucial for spinal injury patients who often experience respiratory issues. Combining these approaches might offer a holistic improvement in motor and respiratory functions that standard therapies don't fully address.

What evidence suggests that this trial's treatments could be effective for improving respiratory function in spinal cord injury?

Research has shown that spinal cord stimulation, one of the treatments in this trial, can greatly improve movement in people with spinal cord injuries. Specifically, 44% of patients moved with assistance or independently, and 87% experienced overall improvement in their abilities. Additionally, respiratory training, another treatment option in this trial, has proven to boost lung function in these patients. Studies have found that training the breathing muscles strengthens them and improves breathing capacity. This trial will also explore combining spinal cord stimulation and respiratory training, which may offer even greater benefits for improving breathing in people with spinal cord injuries. ^{2 3 6 7 8}

Who Is on the Research Team?

Alexander Ovechkin, MD, PhD

Principal Investigator

University of Louisville

Are You a Good Fit for This Trial?

This trial is for adults over 18 with stable, non-progressive spinal cord injuries between C3-T1, who have had the injury for at least two years and have a significant deficit in lung function. It's not suitable for those with severe musculoskeletal pain, unhealed fractures, contractures, active infections or major cardiovascular diseases among other exclusions.

Inclusion Criteria

My spinal cord injury is stable and between the C3 and T1 vertebrae.

My health condition is stable.

At least 15%-deficit in pulmonary function outcomes

Exclusion Criteria

I have a significant hormone-related condition.

I have an illness related to HIV/AIDS.

I do not have any major illnesses that would prevent me from doing breathing exercises.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo epidural spinal cord stimulation and respiratory training

12 months

Regular visits for stimulation and training sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Respiratory Training
• Spinal Cord Epidural Stimulation

Trial Overview The study tests how well electrical stimulation of the spine combined with breathing exercises can help control breathing in people with chronic spinal cord injuries. It aims to find specific stimulation settings that improve neural responses and promote recovery of respiratory functions.

How Is the Trial Designed?

Group I: Spinal Cord Stimulation and Respiratory Training Experimental Treatment 2 Interventions

Research subjects with implanted stimulator undergoing stimulation intervention in combination with respiratory training.

Group II: Spinal Cord Stimulation Active Control 1 Intervention

Research subjects with implanted stimulator undergoing stimulation intervention.

Group III: Respiratory Training Active Control 1 Intervention

Research subjects with no implanted stimulator undergoing RT intervention.

Who Is Running the Clinical Trial?

University of Louisville

Lead Sponsor

Trials

353

Recruited

76,400+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Published Research Related to This Trial

Closed-loop epidural stimulation (CL-ES) can restore breathing activity in paralyzed hemidiaphragms in a rat model of cervical spinal cord injury, demonstrating its potential as a therapeutic intervention for respiratory deficits.

After a 20-minute session of CL-ES, some rats exhibited spontaneous diaphragm activity even after stimulation ceased, suggesting that this treatment may lead to lasting improvements in respiratory function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Closed-loop cervical epidural stimulation partially restores ipsilesional diaphragm EMG after acute C2 hemisection. Mickle, AR., Peñaloza-Aponte, JD., Coffey, R., et al.[2023]

In a pilot study involving 6 participants with spinal cord injuries, an 8-week community exercise program that included inspiratory muscle training (IMT) led to significant improvements in functional measures such as transfer times and trunk strength.

Participants reported positive impacts from the program, suggesting that combining IMT with community exercise may help reduce respiratory complications and improve overall health outcomes for individuals with spinal cord injuries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Community exercise for individuals with spinal cord injury with inspiratory muscle training: A pilot study. Leathem, JM., Macht-Sliwinski, M., Boak, S., et al.[2022]

A 4-week expiratory muscle strength training program, using a pressure threshold device, showed up to a 50% improvement in respiratory muscle strength among healthy individuals and those with conditions like multiple sclerosis and spinal cord injury.

The training protocol, which involves 15-20 minutes of daily exercises five times a week, is designed to enhance expiratory muscle strength and may also positively impact functional outcomes and brain plasticity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Respiratory muscle strength training: functional outcomes versus plasticity. Sapienza, CM., Wheeler, K.[2022]

Inspiratory muscle training (IMT) was found to be feasible and safe for seven adult patients with acute complete cervical or thoracic spinal cord injuries, with all planned sessions successfully delivered without any adverse events.

Some participants showed improvements in lung function, with increases in maximal inspiratory pressure for four individuals and forced vital capacity for three, suggesting potential efficacy of IMT in enhancing respiratory function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Inspiratory muscle training is feasible and safe for patients with acute spinal cord injury. McDonald, T., Stiller, K.[2020]

Lower thoracic spinal cord stimulation (SCS) effectively activates expiratory muscles in dogs, demonstrating significant changes in airway pressure generation, which could help restore effective coughing in patients with spinal cord injuries.

The study showed that SCS can produce substantial positive airway pressures across various lung volumes, indicating its potential as a clinically useful method for improving respiratory function in individuals with paralysis of expiratory muscles.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Electrical activation of the expiratory muscles to restore cough. DiMarco, AF., Romaniuk, JR., Supinski, GS.[2007]

In a randomized controlled trial with 22 cervical spinal cord injury (cSCI) subjects, transcutaneous spinal cord stimulation (tSCS) combined with inspiratory muscle training (IMT) significantly improved respiratory function, including reduced breathlessness and increased thoracic muscle strength.

Subjects receiving tSCS + IMT showed notable enhancements in maximum inspiratory pressure, maximum expiratory pressure, and forced vital capacity, while those who only underwent IMT did not experience significant changes, highlighting the potential of tSCS as an effective adjunct therapy for respiratory rehabilitation in cSCI.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcutaneous Spinal Cord Stimulation Improves Respiratory Muscle Strength and Function in Subjects with Cervical Spinal Cord Injury: Original Research. Kumru, H., García-Alén, L., Ros-Alsina, A., et al.[2023]

Lower thoracic spinal cord stimulation (SCS) effectively activates expiratory muscles in individuals with tetraplegia, achieving high peak airflow rates and airway pressures similar to those seen in healthy individuals during a strong cough.

In a clinical trial involving 9 participants, combined stimulation of two electrode leads produced the highest airflow rates (8.6 L/s) and airway pressures (137 cmH2O), demonstrating the potential of SCS to enhance respiratory function in patients with cervical spinal cord injuries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lower thoracic spinal cord stimulation to restore cough in patients with spinal cord injury: results of a National Institutes of Health-sponsored clinical trial. Part I: methodology and effectiveness of expiratory muscle activation. DiMarco, AF., Kowalski, KE., Geertman, RT., et al.[2021]

Closed-loop electrical epidural stimulation (CLES) applied after a cervical spinal cord injury in rats showed promising results in enhancing respiratory function by facilitating neuroplasticity in spinal respiratory pathways.

This study is the first to demonstrate that CLES can effectively promote respiratory neuroplasticity following a C2 hemisection injury, suggesting it could be a potential therapy for restoring breathing in patients with cervical spinal cord injuries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Closed-Loop, Cervical, Epidural Stimulation Elicits Respiratory Neuroplasticity after Spinal Cord Injury in Freely Behaving Rats. Malone, IG., Kelly, MN., Nosacka, RL., et al.[2023]

Resistive inspiratory muscle training (RIMT) showed a significant short-term improvement in maximum inspiratory pressure (MIP) in 40 participants with spinal cord injury (SCI) during an 8-week inpatient rehabilitation program.

However, the long-term benefits of RIMT were not sustained after the intervention, and no significant effects were observed on other respiratory or functional outcomes, except for an immediate improvement in mental health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Resistive inspiratory muscle training in people with spinal cord injury during inpatient rehabilitation: a randomized controlled trial. Postma, K., Haisma, JA., Hopman, MT., et al.[2014]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7060446/

Effects of Respiratory Muscle Training on Pulmonary Function ... Our findings demonstrate that RMT can effectively improve spinal cord injury pulmonary function of the patient, which is marked by increasing respiratory ...

2. e-arm.org e-arm.org/journal/view.php?number=4404

The Effects of Inspiratory Muscle Training in Individuals With ... Our results showed that IMT may improve MIP, MEP, and VC, but not FEV1, FVC, or QoL, in patients with cervical SCI. Further large-scale studies ...

3. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK72752/

Respiratory muscle training in persons with spinal cord injury This review aimed to assess the effectiveness of respiratory muscle training on a number of clinical and health outcomes in individuals with spinal cord injury.

4. tandfonline.com tandfonline.com/doi/full/10.1080/09638288.2022.2107085

Full article: The effects of inspiratory muscle training on ... Inspiratory muscle training (IMT) significantly improves respiratory muscle strength in adults with spinal cord injuries—irrespective of time since injury, or ...

5. ccforum.biomedcentral.com ccforum.biomedcentral.com/articles/10.1186/s13054-025-05535-z

a network meta-analysis of randomized controlled trials This network meta-analysis (NMA) compared the efficacy of various respiratory training methods in improving respiratory function in patients with spinal cord ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/35931101/

The effects of inspiratory muscle training on ... Moderate quality evidence suggests IMT improves respiratory strength in adults with an SCI. The mental and physical QOL outcomes provided ...

7. clinicaltrials.gov clinicaltrials.gov/show/NCT02396823

Respiratory Motor Control and Blood Pressure Regulation ... The participants will be instructed to perform inspiratory and expiratory efforts against a resistive load. Training session lasts 45 minutes per day, 5 days ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11089516/

Respiratory muscle training for cervical spinal cord injury - PMC We identified no adverse effects of training the breathing muscles for people with a cervical spinal cord injury.