TSS + MST for Spinal Cord Injury

Overseen By Nicholas Evans, MHS, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Shepherd Center, Atlanta GA

Must be taking: Spasticity medications

Disqualifiers: Progressive spinal lesions, Pregnancy, Cardiovascular irregularities, Orthopedic conditions, Implanted stimulators, Cancer, others

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

Compensation: Varies

Number of Visits: 12

28 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores new methods to help people with spinal cord injuries improve their walking ability. Researchers aim to determine if combining motor skill training (MST) with gentle, non-invasive spinal stimulation (TSS) has a greater impact than training alone. Participants with a spinal cord injury who can stand for at least 5 minutes and take a few steps, even with assistance, might be suitable candidates. The study includes six training sessions and could provide valuable insights for easier home-based rehabilitation. As an unphased trial, it offers participants the chance to contribute to innovative research that could enhance rehabilitation techniques for spinal cord injuries.

Will I have to stop taking my current medications?

The trial does not require you to stop taking your current medications, but if you use prescription medication for spasticity, your dosage should not have changed in the last 2 weeks. You must inform the study staff if your medication changes during the study.

What prior data suggests that this combination of MST and TSS is safe for individuals with spinal cord injury?

Research has shown that transcutaneous spinal stimulation (TSS) is generally safe and well-tolerated. TSS uses electrodes to stimulate the spinal cord without surgery and has been safely used in various situations. For instance, it has helped people with spinal cord injuries stand and improve their balance.

One study found that combining TSS with activity-based therapy did not cause serious side effects, suggesting it can be a safe addition to rehabilitation programs.

In children with spinal cord injuries, TSS was also found to be safe for short-term use, supporting its safety across different age groups.

Overall, the research supports the safety of TSS in humans, making it a promising option for those seeking new treatments for spinal cord injury. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it combines Motor Skill Training (MST) and Transcutaneous Spinal Stimulation (TSS) to potentially improve recovery from spinal cord injuries. Unlike traditional treatments, which often focus on physical therapy alone, this approach uses non-invasive electrical stimulation to directly target nerve pathways, potentially enhancing motor function more effectively. The trial also includes a sham comparator group, helping to clarify the specific impact of TSS. By exploring these innovative techniques, researchers hope to uncover new ways to boost rehabilitation outcomes for individuals with spinal cord injuries.

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

Research has shown that combining motor skill training (MST) with transcutaneous spinal stimulation (TSS) can aid recovery in people with spinal cord injuries. In this trial, participants will receive either MST with TSS or MST with sham TSS. Studies have found that MST and TSS together can strengthen muscles and improve walking. For example, one study found that 20 sessions of TSS with regular training improved leg muscle strength and walking ability. Another study showed that ongoing TSS use led to better overall recovery. While results can vary, early findings suggest this combined approach may significantly enhance function and mobility. ^{1 6 7 8 9}

Who Is on the Research Team?

Edelle Field-Fote, PT, PhD

Principal Investigator

Shepherd Center, Atlanta GA

Are You a Good Fit for This Trial?

This trial is for adults aged 18-70 with spinal cord injuries at levels C3-T12, who can independently move each leg and stand with assistance. They must be stable on spasticity medications for at least two weeks and not have progressive spine disorders, implanted stimulators, skin issues near the stimulation site, cardiovascular irregularities, or cancer.

Inclusion Criteria

I can walk at least 3 steps on my own, with or without help from a device.

I can follow instructions and tell someone if I'm in pain.

Ability and willingness to consent and authorize use of personal health information

Exclusion Criteria

My injury is below the T12 spinal level.

I have a history of heart problems.

If you have any implanted devices that use electrical stimulation, you cannot participate in the study because we are not sure how these devices might interact with the treatment.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Wash-in

Participants engage in 6 aerobic and exercise training sessions as part of an existing outpatient clinical program or a personalized exercise plan

2 weeks

6 visits (in-person)

Intervention

Participants are randomized to complete 6 training sessions of motor skill training combined with either TSS or shamTSS

2 weeks

6 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

• Motor Skill Training
• Transcutaneous Spinal Stimulation

Trial Overview The study tests if motor skill training (MST) improves walking in people with spinal cord injury and whether adding transcutaneous spinal stimulation (TSS) leads to greater improvements. Participants will receive MST alone or combined with TSS to see which method better enhances walking ability.

How Is the Trial Designed?

Group I: MST + TSS Experimental Treatment 2 Interventions

Individuals will participate in 6 training sessions of MST combined with TSS.

Group II: MST + ShamTSS Placebo Group 1 Intervention

Individuals will participate in 6 training sessions of MST while receiving shamTSS.

Motor Skill Training is already approved in United States, European Union for the following indications:

Approved in United States as Motor Skill Training for:

• Spinal Cord Injury Rehabilitation
• Improvement of Walking Function
• Reduction of Spasticity

Approved in European Union as Motor Skill Training for:

• Spinal Cord Injury Rehabilitation
• Improvement of Walking Function
• Reduction of Spasticity

Who Is Running the Clinical Trial?

Shepherd Center, Atlanta GA

Lead Sponsor

Trials

30

Recruited

4,000+

National Institute on Disability, Independent Living, and Rehabilitation Research

Collaborator

Trials

83

Recruited

10,500+

Published Research Related to This Trial

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 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]

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 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]

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 18 individuals with subacute motor-incomplete spinal cord injury, combining locomotor training (LT) with transcutaneous spinal stimulation (TSS) showed promising improvements in walking speed and distance after a 4-week program, although no significant differences were found between the TSS and sham groups.

The results suggest that TSS is a feasible addition to LT during rehabilitation, potentially enhancing walking outcomes, but did not significantly affect spasticity, possibly due to high variability in spasticity measurements.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Combined Transcutaneous Spinal Stimulation and Locomotor Training to Improve Walking Function and Reduce Spasticity in Subacute Spinal Cord Injury: A Randomized Study of Clinical Feasibility and Efficacy. Estes, S., Zarkou, A., Hope, JM., et al.[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]

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]

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]

A multicenter randomized clinical trial is investigating the effectiveness of combining spinal cord transcutaneous stimulation (scTS) with activity-based training (ABT) for improving upper extremity function in individuals with cervical spinal cord injury, showing promising preliminary results.

In a small sample of four participants, the combination of scTS and ABT led to immediate and sustained improvements in upper extremity function, with one participant experiencing a remarkable 5-fold increase in function, indicating potential for significant rehabilitation benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Combining Spinal Cord Transcutaneous Stimulation with Activity-based Training to Improve Upper Extremity Function Following Cervical Spinal Cord Injury. Zhang, F., Carnahan, J., Ravi, M., et al.[2023]

Citations

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Transcutaneous spinal cord stimulation combined with ... The outcomes of this study suggest that the combination of standard Lokomat training with tSCS for 20 sessions was effective for LEMS and gait recovery in ...

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. jneuroengrehab.biomedcentral.com jneuroengrehab.biomedcentral.com/articles/10.1186/s12984-025-01557-4

Non-invasive cerebral and spinal cord stimulation for motor ... In this review we aim to compare the effect of non-invasive cerebral and spinal cord stimulation on gait recovery and motor strength of lower limbs in subjects ...

4. nature.com nature.com/articles/s41394-020-00359-1

Feasibility and utility of transcutaneous spinal cord ... Longitudinal recovery and reduced costs after 120 sessions of locomotor training for motor incomplete spinal cord injury. Arch Phys Med ...

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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 ...

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Transcutaneous spinal cord stimulation and motor responses ... Transcutaneous spinal cord stimulation (tSCS) is a non-invasive modality in which electrodes can stimulate spinal circuitries and facilitate a motor response.

7. clinicaltrials.gov clinicaltrials.gov/study/NCT03975634

Transcutaneous Spinal Stimulation: Safety and Feasibility ... The purpose of this study is to determine the feasibility (can we do it) and safety of Transcutaneous Stimulation (TcStim) in children with SCI to acutely ...

8. jneuroengrehab.biomedcentral.com jneuroengrehab.biomedcentral.com/articles/10.1186/s12984-025-01545-8

Transcutaneous spinal cord stimulation combined with robotic ... Although transcutaneous spinal cord stimulation (tSCS) has been suggested as a safe and feasible intervention for gait rehabilitation, no ...

9. nature.com nature.com/articles/s41467-021-26026-z

Noninvasive spinal stimulation safely enables upright ... Transcutaneous spinal stimulation enables trunk stability in adults with SCI and may pose a non-invasive preventative therapeutic alternative.