Neuromodulation Therapy for Spinal Cord Injury

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of Louisville

Must not be taking: Botox, Baclofen

Disqualifiers: Musculoskeletal impairment, Scoliosis surgery, others

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

Compensation: Varies

Number of Visits: 64

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called transcutaneous spinal stimulation (TcStim) to help children with spinal cord injuries (SCI) regain the ability to step. SCI can make it difficult or impossible for children to sit, stand, or walk. The researchers aim to determine if TcStim, a type of neuromodulation therapy, can enhance nerve function in the spinal cord to improve leg movement. Children who have had a spinal cord injury for over a year, cannot walk, and have been discharged from rehabilitation might be suitable candidates. The goal is to discover new ways to help children with SCI move more independently. As an unphased trial, this study provides a unique opportunity for children to potentially benefit from innovative therapy and contribute to groundbreaking research.

Will I have to stop taking my current medications?

If you are currently using oral baclofen or have a baclofen pump, you cannot participate in the trial. Additionally, for certain parts of the trial, you must be willing to stop using baclofen during training.

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 for people with spinal cord injuries. One study found that when combined with rehabilitation, most participants tolerated TcStim well without serious side effects. Another study examined the use of TcStim on different parts of the spine alongside activity-based therapy and found it to be safe, with no major risks. These findings suggest that TcStim is well-tolerated and safe for individuals with spinal cord injuries. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Transcutaneous Spinal Stimulation (TcStim) is unique because it offers a non-invasive way to activate the spinal cord, potentially enhancing recovery for people with spinal cord injuries. Unlike current treatments that often rely on physical therapy alone, TcStim uses electrical currents applied through the skin to promote movement and stepping in the lower limbs. Researchers are excited about this approach because it can be combined with activity-based locomotor training, which may lead to improved outcomes in regaining motor function. This combination of stimulation and training targets the spinal cord's ability to rewire itself, offering new hope for recovery beyond traditional rehabilitation methods.

What evidence suggests that transcutaneous spinal stimulation is effective for spinal cord injury?

Research shows that transcutaneous spinal stimulation (TcStim) holds promise for improving movement in people with spinal cord injuries (SCI). Studies have found that it can help regain some muscle movement. Specifically, using TcStim over time has improved upper body control and stability, as well as leg function, in individuals with SCI. It has also aided in walking and standing. Many participants have experienced significant improvements in movement and physical activities. This trial will evaluate TcStim in various contexts, including acute application and training, to further explore its potential benefits for individuals with SCI. ^{2 3 6 7 8}

Who Is on the Research Team?

Andrea L Behrman, PT, PhD

Principal Investigator

University of Louisville

Are You a Good Fit for This Trial?

This trial is for children aged 4-12 with chronic spinal cord injury (SCI) at T10 or above, who can't stand, walk, or initiate steps. They must be more than a year post-injury and discharged from inpatient rehab. Kids with recent Botox use, scoliosis surgery after SCI, congenital SCI, baclofen treatments, musculoskeletal issues affecting movement, unhealed fractures or total ventilator dependence cannot join.

Inclusion Criteria

I cannot stand, walk, or start walking on my own.

I am between 4 and 12 years old.

My child has had a spinal cord injury above T10 for over a year.

Exclusion Criteria

I have had surgery for scoliosis after a spinal cord injury.

I have not used Botox in the last 3 months.

You rely completely on a ventilator to breathe.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Acute Stimulation Phase

Participants receive transcutaneous spinal stimulation (TcStim) to produce stepping/locomotor activity in lower limbs. Knee, hip, ankle kinematics and electromyography (EMG) of the lower limb muscles are recorded.

4 weeks

Multiple sessions within 4 weeks

Training Phase

Participants undergo 60 sessions of Activity-based locomotor training (AB-LT) combined with TcStim. Ability to initiate and complete a step overground with and without stimulation is assessed.

4 months

60 sessions

Follow-up

Participants are monitored for changes in ability to voluntarily step and muscle activity post-treatment.

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Transcutaneous Spinal Stimulator

Trial Overview The study tests if transcutaneous spinal stimulation (TcStim), using the Biostim-5 device combined with locomotor training can help children step again after an SCI. It will explore how this method affects the spinal circuitry during stepping tasks and whether it improves their ability to step over time.

How Is the Trial Designed?

Group I: Transcutaneous Spinal Stimulation- Acute and with Training. Experimental Treatment 2 Interventions

For Aim 1: Participants will receive transcutaneous stimulation (TcStim) in supine or side lying position at a single or multi site spinal levels to produce stepping/locomotor activity in lower limbs. For Aim 2: TcStim will be delivered while participants are stepping on a computerized treadmill with an overhead partial body weight support (BWS) system and while stepping overground. For Aim 3: Participants will first receive a combination of Activity-based locomotor training (AB-LT)+TcStim for 60 sessions.

Who Is Running the Clinical Trial?

University of Louisville

Lead Sponsor

Trials

353

Recruited

76,400+

Kosair Charities, Inc.

Collaborator

Trials

4

Recruited

110+

Kentucky Spinal Cord and Head Injury Research Trust and Board

Collaborator

Trials

1

Recruited

8+

Published Research Related to This Trial

Spinal cord stimulation (SCS) is evolving from a treatment for intractable pain to a potential method for restoring function after spinal cord injuries, driven by advances in understanding spinal cord lesions and compensatory mechanisms.

New SCS strategies, like spatiotemporal neuromodulation, show promise but require intensive rehabilitation techniques to be effective, highlighting the need for well-designed clinical trials to evaluate safety and efficacy in real-world applications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Advances in Spinal Cord Neuromodulation: The Integration of Neuroengineering, Computational Approaches, and Innovative Conceptual Frameworks. Pradat, PF., Hayon, D., Blancho, S., et al.[2023]

Combining epidural stimulation (ES) with deep brain stimulation (DBS) shows promise in enhancing movement recovery after spinal cord injury (SCI), as it targets both spinal and brain circuits to improve motor function.

Recent studies suggest that DBS of the mesencephalic locomotor region could significantly boost the effectiveness of neuromodulation therapies, indicating a potential new clinical approach for restoring locomotion in individuals with severe SCI.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Combined neuromodulatory approaches in the central nervous system for treatment of spinal cord injury. Noga, BR., Guest, JD.[2023]

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 electrical neurostimulation (TENS) was applied to 20 patients with acute spinal cord injuries and associated severe pain, resulting in over 50% pain relief for 75% of the patients.

TENS is advantageous due to its ease of application, minimal complications, promotion of intestinal peristalsis, and the ability to reduce reliance on narcotic pain medications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcutaneous electrical neurostimulation in musculoskeletal pain of acute spinal cord injuries. Richardson, RR., Meyer, PR., Cerullo, LJ.[2019]

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 electrical spinal cord stimulation combined with physical therapy led to significant improvements in upper extremity function for a 62-year-old male with a chronic incomplete spinal cord injury, including a 52-point increase in strength and sensation scores after four weeks of treatment.

Remarkably, the functional gains achieved persisted for over three months after the treatment ended, indicating that this noninvasive approach can promote lasting neuroplasticity and recovery in individuals with spinal cord injuries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcutaneous Electrical Spinal Stimulation Promotes Long-Term Recovery of Upper Extremity Function in Chronic Tetraplegia. Inanici, F., Samejima, S., Gad, P., et al.[2020]

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]

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 ... These findings indicate that prolonged training with tSCS-ABT can be an effective neuromodulatory intervention for individuals with SCI. Clinical Trial ...

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

Transcutaneous Electrical Spinal Cord Stimulation to ... Enhanced trunk control and stability (9), improved lower extremity (LE) function, locomotor output, and standing (6, 8, 13) as well as reduced ...

4. neurology.org neurology.org/doi/10.1212/WNL.0000000000205724

Transcutaneous Spinal Cord Stimulation (ARC-EX Therapy ... Of sixty participants who completed the in-clinic ARCEX Therapy phase, 72% met the predefined primary effectiveness endpoint. CUE-T scores and ...

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

Feasibility and utility of transcutaneous spinal cord ... These results indicate that TSCS is clinically feasible and may be useful as an adjunct to walking-based therapy for adults with iSCI. Similar ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39893085/

Cardiovascular safety of transcutaneous spinal cord ... This study supports the safety profile of cervical tSCS paired with rehabilitation in individuals with cervical spinal cord injury.

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39998450

Safety and Effectiveness of Multisite Transcutaneous ... Objective: Evaluate the preliminary safety and efficacy of multi-site transcutaneous spinal cord stimulation (tSCS) combined with activity-based ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S1878747925000066

Cardiovascular safety of transcutaneous spinal cord ... This study supports the safety profile of cervical tSCS paired with rehabilitation in individuals with cervical spinal cord injury.