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

9 Participants Needed

Trial Summary

What is the purpose of this trial?

Paralysis of trunk muscles and the inability to sit upright is one of the major problems facing adults and children with spinal cord injury (SCI). Activity-based locomotor training has resulted in improved trunk control in children with spinal cord injury, though full recovery is not achieved in all children. Transcutaneous spinal stimulation' (TcStim), a stimulation applied over the skin to the sensory nerves and spinal cord, is a promising tool that may further enhance improvements to trunk control. 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 improve sitting upright and when used with activity-based locomotor training (AB-LT). Thus, can we provide this therapy to children and do so safely examining a child's immediate response and cumulative response relative to safety and comfort. Eight participants in this study will sit as best they can with and without the stimulation (i.e. stimulation applied across the skin to the nerves entering the spinal cord and to the spinal cord) and their immediate response (safety, comfort, trunk position) recorded. Then, two participants will receive approximately 40 sessions of activity-based locomotor training in combination with the stimulation. Their cumulative response of stimulation (i.e. safety, comfort, feasibility) across time will be documented. Participation in this study may last up to 3 days for the 8 participants being observed for acute response to stimulation and up to 9 weeks for the participants being observed for cumulative response to training with stimulation. We will monitor the participants throughout the testing and training for their response to the stimulation (i.e. safety) and their comfort.

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 data supports the effectiveness of the treatment Transcutaneous Spinal Stimulation for Spinal Cord Injury?

Research shows that Transcutaneous Spinal Stimulation (TSS) can activate muscles and improve voluntary movement, muscle strength, and function in people with spinal cord injuries. However, more studies are needed to fully understand the best ways to use this treatment. ^{1 2 3 4 5}

Is transcutaneous spinal stimulation (TSS) safe for humans?

Transcutaneous spinal stimulation (TSS) is generally considered safe, but it can cause discomfort at high levels of stimulation. Studies have explored ways to reduce this discomfort, but no method has been found to be significantly better than the standard approach. ^{1 6 7 8 9}

How is transcutaneous spinal stimulation different from other treatments for spinal cord injury?

Transcutaneous spinal stimulation (TSS) is unique because it is a non-invasive treatment that uses electrodes placed on the skin to stimulate the spinal cord, helping to improve muscle movement and strength in people with spinal cord injuries. Unlike other treatments, TSS does not require surgery and can activate both lower and upper limb muscles, potentially enhancing voluntary movement and function. ^{1 2 5 8 10}

Research Team

Andrea L Behrman, PhD, PT

Principal Investigator

University of Louisville

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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]

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]

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 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]

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]

References

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

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

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

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

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

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

4. Switzerland pubmed.ncbi.nlm.nih.gov

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

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

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

6. 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]

7. United States 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. [2021]

8. England pubmed.ncbi.nlm.nih.gov

Effects of transcutaneous spinal stimulation on spatiotemporal cortical activation patterns: a proof-of-concept EEG study. [2022]

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

The Incidence of Spinal Cord Injury in Implantation of Percutaneous and Paddle Electrodes for Spinal Cord Stimulation. [2022]

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

Enhanced selectivity of transcutaneous spinal cord stimulation by multielectrode configuration. [2023]