Non-Invasive Spinal Cord Stimulation for Spinal Cord Injury

Overseen By Eddie Brown, MS, MBA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Louisville

Disqualifiers: Ventilator dependence, Major pulmonary, Cardiovascular, others

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

Compensation: Varies

Number of Visits: 12

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method to improve breathing and muscle function in people with spinal cord injuries using electrical spinal cord stimulation (Transcutaneous Electrical Spinal Cord Stimulation, TcESCS). It examines various combinations of training and stimulation to determine which best aids the lungs and muscles used for breathing. Individuals with spinal cord injuries who have experienced reduced lung function for over a year and are not on a ventilator may be suitable candidates. The goal is to discover better treatments for those facing breathing and movement challenges due to spinal cord injuries. As an unphased trial, this study allows participants to contribute to groundbreaking research that could lead to innovative treatments for spinal cord injuries.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Studies have shown that Transcutaneous Electrical Spinal Cord Stimulation (TcESCS) is generally safe for people with spinal cord injuries. Research indicates that using TcESCS alongside rehabilitation maintains a good safety record, with no major safety issues reported. For example, one study found that participants experienced improved strength and control without serious side effects. Another study examined TcESCS in a clinical setting and found it both safe and practical.

Overall, available evidence suggests that TcESCS is well-tolerated. However, as with any treatment, individual experiences may vary, so discussing any concerns with a healthcare provider is important. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about transcutaneous electrical spinal cord stimulation (TcESCS) because it offers a non-invasive approach to enhancing physical function in individuals with spinal cord injuries. Unlike traditional treatments, which might include medications or surgical interventions, TcESCS uses electrical impulses applied through the skin to stimulate the spinal cord, potentially improving respiratory, arm, and trunk functions without the need for invasive procedures. This method also allows for combining stimulation with specific physical training, such as respiratory, arm, or trunk training, which could lead to more comprehensive rehabilitation outcomes. The ability to tailor stimulation and training combinations makes TcESCS a promising avenue for personalized treatment strategies in spinal cord injury rehabilitation.

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

Research has shown that transcutaneous electrical spinal cord stimulation (TcESCS) can help people with spinal cord injuries regain movement. In this trial, some participants will receive TcESCS alone, while others will receive it combined with specific physical exercises, such as respiratory, arm, or trunk training. Some studies have found that combining TcESCS with physical exercises can lead to better recovery, especially after many sessions. This method activates nerves below the injury, potentially improving movement and strength. Researchers are also investigating how pairing TcESCS with exercises like breathing or arm workouts can benefit lung and muscle function. Overall, TcESCS shows promise for aiding recovery after spinal cord injuries. ^{3 6 7 8 9}

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 with stable, non-progressive spinal cord injuries at T5 or above, who've had the injury for over a year and have reduced lung function. It's not suitable for those with untreated musculoskeletal issues, fractures, contractures, sores, ventilator dependence, severe mental health issues or substance abuse problems.

Inclusion Criteria

My lung function tests show healthy breathing capacity.

I am 21 years old or older.

I am not disabled and meet the study's gender criteria.

Exclusion Criteria

You have not received treatment for depression, have a mental health condition, or are currently using drugs excessively.

I have a bone that hasn't healed yet.

I have not received treatment for a muscle or joint problem.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive non-invasive transcutaneous electrical spinal-cord stimulation (TcESCS) combined with various training interventions such as respiratory, arm, and trunk training.

12 weeks

Up to 12 visits for TcESCS mapping and assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments of motor and respiratory functions.

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Transcutaneous Electrical Spinal Cord Stimulation (TcESCS)

Trial Overview The study tests how different combinations of respiratory training and electrical stimulation affect lung and muscle function in people with spinal cord injuries. The effectiveness of these therapies will be measured by changes in lung capacity and trunk muscle performance.

How Is the Trial Designed?

Group I: Spinal Cord Injured (SCI) intervention groups Experimental Treatment 1 Intervention

The respiratory training (RT) group (n=6) will receive the respiratory training intervention only); the transcutaneous electrical spinal cord stimulation (TcESCS) group (n=6) will receive transcutaneous spinal cord stimulation only; TcESCS + RT group (n=6) will receive TcESCS combined with RT; TcESCS + Arm Training (AT) group (n=6) will receive TcESCS combined with AT; and TcESCS + Trunk Training (TT) group (n=6) will receive TcESCS combined with TT.

Group II: Non-Disabled (ND) and Spinal Cord Injured (SCI) controls Experimental Treatment 1 Intervention

The ND Control group (n=6) and SCI Control group (n=6) will be used to assess related values as acute effects of transcutaneous electrical spinal cord stimulation (TcESCS) itself and will not receive any training intervention. The ND group will receive baseline assessments, then up to 12 (4-Respiratory function, 4-Arm function, and 4-Trunk function) TcESCS mapping experiments, followed by repeating the assessments in the presence of TcESCS. The investigators will decide which stimulation type should be used for the post-mapping assessments.

Who Is Running the Clinical Trial?

University of Louisville

Lead Sponsor

Trials

353

Recruited

76,400+

Published Research Related to This Trial

Cervical transcutaneous spinal cord stimulation (tSCS) can effectively activate sensory fibers at lower stimulation intensities when the cathode electrode is positioned at the C7 or T1 vertebra, compared to C6, which may enhance rehabilitation outcomes for upper-limb motor recovery after spinal cord injury.

Using smaller electrode sizes not only lowers the activation threshold for sensory fibers but also optimizes the recruitment of these fibers before α-motor fibers, suggesting a strategic approach to improve hand muscle activation during tSCS therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Optimizing sensory fiber activation during cervical transcutaneous spinal stimulation using different electrode configurations: A computational analysis. de Freitas, RM., Capogrosso, M., Nomura, T., et al.[2022]

In a study of 25 patients with chronic motor complete spinal cord injury, spinal cord epidural stimulation (scES) was found to be safe, with only 8% experiencing infections and 12% requiring additional procedures, while all participants achieved voluntary movement after the intervention.

The majority of patients (85%) reported that scES met or exceeded their expectations, and 100% expressed willingness to undergo the procedure again, indicating significant improvements in motor function and quality of life after treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Spinal cord epidural stimulation for motor and autonomic function recovery after chronic spinal cord injury: A case series and technical note. Boakye, M., Ball, T., Dietz, N., et al.[2023]

Noninvasive transcutaneous spinal cord stimulation (tSCS) has been shown to effectively induce muscle activation in individuals with spinal cord injury, based on a systematic review of 13 studies involving 55 participants.

While tSCS appears to enhance voluntary movement, muscle strength, and function, further research is needed to determine the optimal electrode placement and current intensity for maximum efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcutaneous Spinal Cord Stimulation and Motor Rehabilitation in Spinal Cord Injury: A Systematic Review. Megía García, A., Serrano-Muñoz, D., Taylor, J., et al.[2021]

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]

Transcutaneous spinal cord stimulation (tSCS) shows potential for generating motor activity in individuals with spinal cord injury, but the overall quality of the studies reviewed was poor-to-fair, indicating a need for more rigorous research.

The review identified significant variability in stimulation parameters and outcome measurements across the 25 studies analyzed, highlighting the necessity for standardized methods to improve the reliability and comparability of tSCS research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcutaneous spinal cord stimulation and motor responses in individuals with spinal cord injury: A methodological review. Taylor, C., McHugh, C., Mockler, D., et al.[2022]

The risk of neurologic injury from the surgical implantation of paddle type spinal cord stimulation electrodes is low, estimated at below 0.6%, based on primary data analysis.

Despite the rarity of these complications, the study emphasizes the importance of implementing preoperative, intraoperative, and postoperative measures to further minimize risks and improve procedural safety, along with careful patient follow-up.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Incidence and avoidance of neurologic complications with paddle type spinal cord stimulation leads. Levy, R., Henderson, J., Slavin, K., et al.[2022]

In a study analyzing 2053 cases of cervical spinal cord stimulation (cSCS) from 2002 to 2011, the rate of spinal cord injury was found to be 0.5%, which is higher than previously reported, indicating a need for careful patient selection and counseling.

Despite the spinal cord injury rate, cSCS remains a relatively safe procedure with low rates of other complications (1.1% neurological, 1.4% medical, and 11.7% general perioperative complications), making it a viable option for pain management in patients, especially in an aging population reliant on opioids.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rate of perioperative neurological complications after surgery for cervical spinal cord stimulation. Chan, AK., Winkler, EA., Jacques, L.[2017]

Transcutaneous spinal direct current stimulation (tsDCS) can modulate corticospinal excitability in individuals with chronic incomplete spinal cord injury, showing trends of increased excitability on one side and decreased on the other, depending on the stimulation polarity.

In a study with six participants, no significant differences were found between stimulation conditions, but the results suggest that further research is needed to optimize electrode placement and explore the potential for improved movement function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of transcutaneous spinal direct current stimulation on corticospinal excitability in chronic incomplete spinal cord injury. Powell, ES., Carrico, C., Salyers, E., et al.[2018]

In a study of 69 patients with implanted spinal cord stimulators (SCSs) who underwent 78 MRI scans, the overall adverse event rate for off-label MRI use was low at 9.72%, with no serious adverse events reported.

All reported clinical adverse events were minor and resolved, suggesting that the benefits of MRI for pain management in patients with older SCS models may outweigh the associated risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Off-Label Magnetic Resonance Imaging (MRI) in Patients with Persistent Pain with Spinal Cord Stimulators: A Case Series. Ragukonis, T.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12548825/

Protocol for a Systematic Review and Meta-Analysis - PMC Transcutaneous spinal cord stimulation (tSCS) has emerged as a promising neuromodulation technique for enhancing motor recovery and walking ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S1094715925000078

Safety and Effectiveness of Multisite Transcutaneous ... Combined tSCS + ABT facilitated functional recovery after chronic SCI. Improvements required ≥60 tSCS-ABT sessions, with further exposure to tSCS facilitating ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT03137108

Effects of Transcutaneous Spinal Cord Stimulation on ... The aim of this study is to investigate the immediate effects of tSCS with different stimulation modalities on voluntary motor control in patients with ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9396932/

Transcutaneous Electrical Spinal Cord Stimulation to ... All outcome data ... Injury volume extracted from MRI predicts neurologic outcome in acute spinal cord injury: a prospective TRACK-SCI pilot study ...

5. frontiersin.org frontiersin.org/journals/rehabilitation-sciences/articles/10.3389/fresc.2021.740307/full

Transcutaneous Electrical Spinal Cord Stimulation to ... All outcome data ... Injury volume extracted from MRI predicts neurologic outcome in acute spinal cord injury: a prospective TRACK-SCI pilot study ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39893085/

Cardiovascular safety of transcutaneous spinal cord ... This study supports the safety profile of cervical tSCS paired with rehabilitation in individuals with cervical spinal cord injury.

7. sciencedirect.com sciencedirect.com/science/article/pii/S1878747925000066

Cardiovascular safety of transcutaneous spinal cord ... This study supports the safety profile of cervical tSCS paired with rehabilitation in individuals with cervical spinal cord injury.

8. neuromodulationjournal.org neuromodulationjournal.org/article/S1094-7159(23)00648-7/fulltext

Safety and Feasibility of Cervical and Thoracic ... In adults with cervical spinal cord injury (SCI), transcutaneous spinal stimulation (scTS) has improved upper extremity strength and control ...

9. clinicaltrials.gov clinicaltrials.gov/study/NCT01949285

NCT01949285 | Transcutaneous Electrical Spinal Cord ... This study is to determine if non-invasive electrical stimulation of the spinal cord can be used to: 1) assess spared function following a spinal cord injury; ...