Transcutaneous Spinal Stimulation for Spinal Cord Injury

Overseen By Lisa Clayton, B.S.

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of Louisville

Must not be taking: Botox, Baclofen

Disqualifiers: Unhealed fracture, Scoliosis surgery, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 43

What You Need to Know Before You Apply

What is the purpose of this trial?

The trial aims to test a new method called Transcutaneous Spinal Stimulation (TcStim) to improve trunk control in children with spinal cord injuries. This method applies gentle electrical stimulation over the skin to the nerves and spinal cord, which might enhance the ability to sit upright when combined with special physical training. The trial evaluates whether this method is both safe and feasible. Children who have experienced a spinal cord injury, have difficulty sitting up, and have already undergone specific physical therapy might be suitable candidates. As an unphased trial, this study offers a unique opportunity for children to potentially benefit from innovative therapy while contributing to important research.

Will I have to stop taking my current medications?

The trial requires that you stop using baclofen if you are currently taking it, as it is listed in the exclusion criteria.

What prior data suggests that Transcutaneous Spinal Stimulation is safe for children with spinal cord injury?

Research has shown that transcutaneous spinal stimulation (TcStim) is generally safe. This method involves applying stimulation over the skin to the nerves and spinal cord. Studies have found that people with spinal cord injuries tolerate it well. For example, one study found that TcStim was safe for children, with safety results similar to a fake (inactive) treatment, indicating a low risk of side effects. Another study on adults showed that TcStim improved muscle control and strength without major safety issues. While more research is always beneficial, current evidence supports the safety of TcStim for aiding trunk control in spinal cord injury cases. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatment for spinal cord injury, which often involves surgery and rehabilitation, transcutaneous spinal stimulation is a non-invasive technique that stimulates the spinal cord through the skin. This method aims to improve trunk control and mobility by delivering electrical impulses to the spinal cord, potentially enhancing neural activity and promoting recovery. Researchers are excited about this approach because it could offer a safer and more convenient alternative to invasive procedures, with the possibility of being integrated into regular physical therapy sessions to boost outcomes.

What evidence suggests that Transcutaneous Spinal Stimulation is effective for improving trunk control in children with spinal cord injury?

Research has shown that transcutaneous spinal stimulation (TcStim), which participants in this trial will receive, may improve movement in people with spinal cord injuries. Studies have found that combining TcStim with exercises can enhance recovery, though many sessions are often necessary for significant improvements. Specifically, individuals with spinal injuries have demonstrated better upper body control and an improved ability to sit. TcStim is considered safe, with most participants experiencing positive outcomes. Overall, evidence suggests that TcStim could effectively help people with spinal cord injuries regain movement. ^{2 3 4 6 7}

Who Is on the Research Team?

Andrea L Behrman, PhD, PT

Principal Investigator

University of Louisville

Are You a Good Fit for This Trial?

This trial is for children with chronic spinal cord injury who have completed at least 60 sessions of locomotor training. They should struggle to sit upright without arm support and not be using certain muscle relaxants or have unhealed fractures, recent Botox treatments, total ventilator dependence, or other complications that limit participation.

Inclusion Criteria

I have been discharged from in-patient rehab.

I have been discharged from in-patient rehab.

I have a long-term spinal cord injury affecting my muscle control.

Exclusion Criteria

You rely completely on a ventilator to breathe.

I am currently taking baclofen.

You were born with a spinal cord injury.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

Acute Response Assessment

Participants are assessed for immediate response to transcutaneous spinal stimulation, including safety, comfort, and trunk position.

3 days

3 visits (in-person)

Cumulative Response Assessment

Participants undergo 40 sessions of activity-based locomotor training combined with transcutaneous spinal stimulation to assess cumulative response.

9 weeks

40 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Transcutaneous Spinal Stimulation

Trial Overview

The study tests the safety and feasibility of Transcutaneous Spinal Stimulation (TcStim) in improving trunk control when sitting. It involves immediate response testing in eight children and a longer-term test with about 40 sessions combined with locomotor training in two children.

How Is the Trial Designed?

Group I: Transcutaneous spinal stimulation Experimental Treatment 1 Intervention

Safety and feasibility outcome measures are collected during application of transcutaneous spinal stimulation while trunk control is assessed at 3 time points (acute) and/or while transcutaneous stimulation is applied in combination with activity-based locomotor training (40 sessions, 1.5 hours/day, 5 days/week; stimulation will be applied intermittently for no more than 10 minutes at a time during training)

Transcutaneous Spinal Stimulation is already approved in United States, European Union for the following indications:

Approved in United States as Transcutaneous Spinal Stimulation for:

• Spinal cord injury rehabilitation
• Improvement of walking function
• Reduction of spasticity

Approved in European Union as Transcutaneous Spinal Stimulation for:

• Spinal cord injury rehabilitation
• Improvement of walking function
• Reduction of spasticity

Who Is Running the Clinical Trial?

University of Louisville

Lead Sponsor

Trials

353

Recruited

76,400+

National Center of Neuromodulation for Rehabilitation (NM4R)

Collaborator

Trials

1

Recruited

9+

National Center of Neuromodulation for Rehabilitation

Collaborator

Trials

12

Recruited

240+

Published Research Related to This Trial

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]

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]

Transcutaneous spinal cord stimulation (tSCS) can enhance muscle recruitment selectivity when using multielectrode configurations, as shown in a study with 16 participants, which may improve rehabilitation outcomes for paralyzed muscles after spinal cord injury.

The study found that spatially selective tSCS activates specific motor neurons through proprioceptive fibers, indicating a mechanism that could lead to more effective rehabilitation protocols targeting single-joint movements.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Enhanced selectivity of transcutaneous spinal cord stimulation by multielectrode configuration. Bryson, N., Lombardi, L., Hawthorn, R., et al.[2023]

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 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 cord stimulation (TSS) significantly affects brain activity, activating key areas related to movement control and planning, as shown by EEG analysis in five participants performing lower-limb tasks.

TSS resulted in notable changes in functional connectivity in the brain during stimulation, unlike functional electrical stimulation (FES), suggesting TSS may be more effective for enhancing cortical engagement in rehabilitation strategies for spinal cord injury.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of transcutaneous spinal stimulation on spatiotemporal cortical activation patterns: a proof-of-concept EEG study. Steele, AG., Manson, GA., Horner, PJ., et al.[2022]

In a study with 10 healthy participants, transcutaneous spinal stimulation (TSS) using a 5 kHz carrier frequency was tolerated better than conventional stimulation methods, allowing for higher stimulation levels without discomfort.

Despite the improved tolerance with the carrier frequency, when comparing the intensity needed to evoke muscle responses, all stimulation paradigms were equally effective, indicating that discomfort reduction does not enhance the efficacy of TSS in eliciting motor responses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The relationship between maximum tolerance and motor activation during transcutaneous spinal stimulation is unaffected by the carrier frequency or vibration. Manson, GA., Calvert, JS., Ling, J., et al.[2021]

In a study involving 31 patients with spinal cord injury, transcutaneous electrical nerve stimulation (TENS) was found to be more effective in treating pain directly at the injury site compared to radiating or central pain.

The results suggest that the location of pain significantly influences the success of TENS treatment, highlighting the need for targeted pain management strategies in spinal cord injury patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcutaneous nerve stimulation for treatment of pain in patients with spinal cord injury. Davis, R., Lentini, R.[2004]

In a study of 8326 patients who underwent spinal cord stimulation (SCS) implantation, the overall incidence of spinal cord injury (SCI) was found to be low at 2.13%, indicating that SCS is a generally safe procedure.

There was no significant difference in the rates of SCI or spinal hematoma between patients receiving percutaneous (2.35%) and paddle (1.71%) electrode implantation, suggesting similar safety profiles for both methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Incidence of Spinal Cord Injury in Implantation of Percutaneous and Paddle Electrodes for Spinal Cord Stimulation. Petraglia, FW., Farber, SH., Gramer, R., et al.[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.

frontiersin.org

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

Transcutaneous Electrical Spinal Cord Stimulation to ...

To evaluate the impact of using transcutaneous electrical spinal cord stimulation (TSCSTSCS) on upper and lower extremity function in individuals with chronic ...

4.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06587841

Noninvasive Spinal Cord Stimulation for Early SCI

The purpose of this clinical study is to investigate the safety and effectiveness of non-surgical transcutaneous spinal cord stimulation (TSCS) in helping with ...

5.

nature.com

nature.com/articles/s41591-024-02940-9

Non-invasive spinal cord electrical stimulation for arm and ...

ARCEX Therapy was found to be safe and effective in 72% of participants to mediate improvements of strength and function in the hands and arms ...

6.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/39998450

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 ...

7.

hopkinsmedicine.org

hopkinsmedicine.org/clinical-trials/results/irb00300695

Transcutaneous spinal stimulation (TSS) in children with ...

Administration of TSCS to children in a clinical setting will be safe based on similar safety outcomes as sham TSCS.