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

6 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment Activity-Based Recovery Training and Transcutaneous Spinal Cord Stimulation for spinal cord injury?

Research shows that combining transcutaneous spinal cord stimulation with activity-based training can improve walking and upper extremity function in people with spinal cord injuries. Studies found that this combination led to significant improvements in walking speed and distance, as well as upper extremity function, compared to training alone. ^{1 2 3 4 5}

Is spinal cord stimulation safe for humans?

Research shows that spinal cord stimulation, including transcutaneous spinal stimulation, is generally safe for humans. Studies have evaluated its use in improving walking and upper extremity function in spinal cord injury patients without significant safety concerns. ^{1 4 6 7 8}

How does the treatment Spinal Cord Stimulation + Recovery Training for Spinal Cord Injury differ from other treatments?

This treatment is unique because it combines activity-based recovery training with transcutaneous spinal cord stimulation, a non-invasive method that enhances the excitability of spinal circuits to improve motor function. Unlike other therapies that focus solely on repetitive task-specific activities, this approach leverages neuromodulation to potentially reactivate dormant neural pathways, offering a novel way to facilitate recovery in spinal cord injury patients. ^{1 3 4 9 10}

What is the purpose of this trial?

The purpose of this study is to deepen our understanding of children who have a cervical spinal cord injury obtained in utero or at birth and examine the effects of tailored activity-based recovery training (ABRT) in combination with transcutaneous spinal cord stimulation (scTS). This is a within subjects, pre-post design study. Neurophysiological, sensorimotor, and autonomic assessments will occur pre, interim, and post 40 sessions of ABRT in conjunction with scTs.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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 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]

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]

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]

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]

References

1. Switzerland 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. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Spinal Cord Stimulation and Augmentative Control Strategies for Leg Movement after Spinal Paralysis in Humans. [2020]

3. Switzerland pubmed.ncbi.nlm.nih.gov

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

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

Combining Spinal Cord Transcutaneous Stimulation with Activity-based Training to Improve Upper Extremity Function Following Cervical Spinal Cord Injury. [2023]

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

Transcutaneous Spinal Cord Stimulation Induces Temporary Attenuation of Spasticity in Individuals with Spinal Cord Injury. [2021]

6. England pubmed.ncbi.nlm.nih.gov

Spinal Cord Stimulation Provides Pain Relief with Improved Psychosocial Function: Results from EMP3OWER. [2018]

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

Best Practices in Spinal Cord Stimulation. [2021]

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

Spinal Cord Stimulation Research in the Restoration of Motor, Sensory, and Autonomic Function for Individuals Living With Spinal Cord Injuries: A Scoping Review. [2022]

9. Netherlands pubmed.ncbi.nlm.nih.gov

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

10. Switzerland pubmed.ncbi.nlm.nih.gov

Novel Noninvasive Spinal Neuromodulation Strategy Facilitates Recovery of Stepping after Motor Complete Paraplegia. [2022]