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

36 Participants Needed

Trial Summary

What is the purpose of this trial?

The goal of this study is to assess the function of the lungs and the muscles are used to breathe after individuals receive respiratory training, spinal cord stimulation, a combination of respiratory training and stimulation, a combination of arm training and stimulation, or a combination of trunk training and stimulation. The respiratory, arm, and trunk training combined with the spinal stimulation interventions are being used to activate the spinal cord below the level of injury. Investigators will be looking for changes in the function of the lungs and trunk muscles before, during, and after these task-specific and non-task-specific interventions for breathing to determine which one has the greatest effect. The results of this study may aid in the development of treatments to help individuals with spinal cord injuries that have impaired lung, arm, and trunk function.

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 data supports the effectiveness of the treatment Transcutaneous Electrical Spinal Cord Stimulation (TcESCS) for spinal cord injury?

Research shows that Transcutaneous Electrical Spinal Cord Stimulation (TcESCS) can help improve muscle activation and voluntary movement in people with spinal cord injuries. Studies have found that this non-invasive treatment can enhance motor function in both the upper and lower limbs, suggesting it may be a promising therapy for recovery. ^{1 2 3 4 5}

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

Transcutaneous spinal cord stimulation (tSCS) is considered relatively safe, with studies showing low rates of complications. Although specific data on tSCS safety is limited, related procedures like cervical spinal cord stimulation have shown low complication rates, suggesting that non-invasive methods may also be safe. ^{2 6 7 8 9}

How is the treatment Transcutaneous Electrical Spinal Cord Stimulation (TcESCS) different from other treatments for spinal cord injury?

Transcutaneous Electrical Spinal Cord Stimulation (TcESCS) is unique because it is a non-invasive treatment that uses electrodes placed on the skin to stimulate the spinal cord, helping to improve motor function in people with spinal cord injuries. Unlike other treatments that may require surgery or medication, TcESCS directly targets spinal circuitries to enhance voluntary movement and muscle strength without the need for invasive procedures. ^{1 2 3 4 10}

Research Team

Alexander Ovechkin, MD, PhD

Principal Investigator

University of Louisville

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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 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]

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]

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]

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]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

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

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

Transcutaneous spinal cord stimulation and motor responses in individuals with spinal cord injury: A methodological review. [2022]

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

Optimizing sensory fiber activation during cervical transcutaneous spinal stimulation using different electrode configurations: A computational analysis. [2022]

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

Transcutaneous Spinal Cord Stimulation and Motor Rehabilitation in Spinal Cord Injury: A Systematic Review. [2021]

5. United States 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. [2023]

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

Incidence and avoidance of neurologic complications with paddle type spinal cord stimulation leads. [2022]

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

Review of Efficacy and Safety of Spinal Cord Stimulation in Veterans. [2023]

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

Rate of perioperative neurological complications after surgery for cervical spinal cord stimulation. [2017]

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

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

10. Netherlands pubmed.ncbi.nlm.nih.gov

The effect of transcutaneous spinal direct current stimulation on corticospinal excitability in chronic incomplete spinal cord injury. [2018]