Spinal Cord Stimulation + Recovery Training for Spinal Cord Injury

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of Louisville

Must not be taking: Botox, Baclofen

Disqualifiers: Severe scoliosis, Allodynia, Ventilator-dependence, others

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

Compensation: Varies

Number of Visits: 5

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore the effectiveness of combining activity-based recovery training (ABRT) with transcutaneous spinal cord stimulation (scTS, a non-invasive therapy) for children with spinal cord injuries occurring before or during birth. Researchers seek to understand how this treatment affects physical functions such as movement and nerve responses. Daily sessions include exercises for sitting, standing, walking, and hand tasks, repeated over 40 sessions. Children with a cervical spinal cord injury diagnosed at birth who have completed hospital rehabilitation are suitable candidates for this study. As an unphased trial, this study offers a unique opportunity for children to potentially enhance their physical functions through innovative therapies.

Will I have to stop taking my current medications?

The trial requires that you stop using Botox for at least 3 months before participating and you cannot be using oral baclofen or a baclofen pump.

What prior data suggests that this protocol is safe for children with spinal cord injury?

Research has shown that both activity-based recovery training (ABRT) and transcutaneous spinal cord stimulation (scTS) are generally safe for people with spinal cord injuries (SCI). ABRT aids muscle recovery and improves movement in both adults and children after a spinal cord injury. This therapy is well-tolerated and can be safely used in community settings.

For scTS, research indicates it is safe and practical in clinical settings. It has helped many participants improve strength and movement in their arms and hands. Studies have demonstrated that combining scTS with activity-based training can support recovery after a spinal cord injury. While these treatments are generally safe, monitoring for any individual side effects remains important. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the combination of Activity-Based Recovery Training (ABRT) and Transcutaneous Spinal Cord Stimulation (scTS) for spinal cord injury because it offers a new way to enhance recovery by directly targeting the nervous system. Unlike traditional rehabilitation methods that focus primarily on physical therapy and medication, this approach uses electrical stimulation delivered through the skin to activate nerve circuits in the spinal cord. This innovative technique, combined with intensive, tailored physical training, aims to improve motor and sensory functions more effectively. By potentially enhancing the body's natural healing processes, this treatment could offer new hope for individuals with high and low cervical spinal cord injuries.

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

Research has shown that combining activity-based recovery training (ABRT) with spinal cord stimulation can greatly improve movement and independence in people with spinal cord injuries. In this trial, participants will receive both ABRT and transcutaneous spinal cord stimulation (tSCS) as part of their treatment. One study found that participants enhanced their motor skills in both their arms and legs after intensive physical therapy. Another study demonstrated that spinal cord stimulation, when used with activity-based training, improved walking and voluntary muscle control. Transcutaneous spinal cord stimulation has been shown to help restore movement over time by boosting nerve signals. These findings suggest that using ABRT with tSCS may effectively support recovery after a spinal cord injury. ^{2 4 6 7 8}

Are You a Good Fit for This Trial?

This trial is for children with a cervical spinal cord injury that occurred in the womb or at birth. They will participate in assessments before, during, and after undergoing 40 sessions of specialized recovery training combined with non-invasive spinal stimulation.

Inclusion Criteria

I have a spinal cord injury in my neck from birth.

I have been discharged from the hospital or a rehab center.

Exclusion Criteria

I am not willing to stop using my daytime back or leg braces during the study.

I experience pain from touches that are not usually painful.

I have not used Botox in the last 3 months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo 40 sessions of tailored activity-based recovery training (ABRT) in combination with transcutaneous spinal cord stimulation (scTS)

8 weeks

5 visits per week (in-person)

Interim Assessment

Neurophysiological, sensorimotor, and autonomic assessments conducted after 20 sessions

1 week

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Activity-Based Recovery Training
• Transcutaneous Spinal Cord Stimulation

Trial Overview

The study is testing how effective activity-based recovery training (ABRT) paired with transcutaneous spinal cord stimulation (scTS) can be for young patients with early-life spinal injuries. It's a pre-post design where each child serves as their own control over time.

How Is the Trial Designed?

Group I: Cervical Perinatal SCI Experimental Treatment 2 Interventions

Participants with high cervical and low cervical SCI will perform tailored ABRT+scTS. Pre, interim, and post assessments of neurophysiological, sensorimotor, and autonomic function will be compared within-subjects and between high and low cervical SCI groups. Participants will come for daily activity-based recovery training (ABRT) + transcutaneous spinal stimulation (scTS). ABRT+scTS will take place 5 days per week for approximately 2.5 hours each (1.5 hours of lower extremity training and 1 hour of upper extremity training) for a total of 40 sessions consisting of facilitated sitting, standing, stepping, and UE motor tasks such as grasping, reaching, and hand manipulations.

Who Is Running the Clinical Trial?

University of Louisville

Lead Sponsor

Trials

353

Recruited

76,400+

Vanderbilt University

Collaborator

Trials

714

Recruited

6,143,000+

University of Leeds

Collaborator

Trials

305

Recruited

9,966,000+

Kentucky Spinal Cord and Head Injury Research Trust

Collaborator

Trials

1

Recruited

6+

Published Research Related to This Trial

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]

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 (SCS) significantly reduced spasticity in 12 individuals with spinal cord injury, showing immediate and lasting effects on measures like the Modified Ashworth Scale and clonus after a single 30-minute session.

A follow-up study over 6 weeks indicated that self-administered transcutaneous SCS could lead to progressive improvements in spasticity, suggesting it may be an effective non-invasive treatment option for managing spasticity in patients with spinal cord injuries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcutaneous Spinal Cord Stimulation Induces Temporary Attenuation of Spasticity in Individuals with Spinal Cord Injury. Hofstoetter, US., Freundl, B., Danner, SM., 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]

A case study of a 27-year-old male with chronic spinal cord injury showed that combining locomotor training with multi-segmental spinal cord transcutaneous electrical stimulation (scTS) can enhance recovery of locomotion by reactivating dormant spinal networks.

After a 3-month training regimen, improvements in stepping coordination were observed, indicating that scTS may facilitate neuroplastic changes and better sensory-motor integration, which are crucial for functional recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Novel Noninvasive Spinal Neuromodulation Strategy Facilitates Recovery of Stepping after Motor Complete Paraplegia. Siu, R., Brown, EH., Mesbah, S., et al.[2022]

Epidural spinal cord stimulation can activate spared neural circuitry below severe spinal cord injuries, enabling paralyzed individuals to achieve motor outputs like standing and stepping during assisted treadmill exercises.

This stimulation not only generates immediate motor responses but also supports rehabilitation by promoting long-term neural plasticity, potentially leading to lasting improvements in motor function for patients with spinal cord injuries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Spinal Cord Stimulation and Augmentative Control Strategies for Leg Movement after Spinal Paralysis in Humans. Minassian, K., Hofstoetter, US.[2020]

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]

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