Neuromodulation Therapy for Spinal Cord Injury

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of Louisville

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

Compensation: Varies

Number of Visits: 64

8 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial aims to test if electrical stimulation through the skin can help children with severe spinal cord injuries improve their ability to move and walk. The study will involve 8 children who cannot walk due to their injuries. Researchers hope that this treatment can reactivate the nerves in the spinal cord to help these children regain some movement. Electrical stimulation has been studied for its potential to improve movement and posture in individuals with spinal cord injuries.

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 data supports the effectiveness of the treatment Transcutaneous Spinal Stimulator for spinal cord injury?

Research shows that transcutaneous spinal stimulation, when combined with physical therapy, can significantly improve motor control and strength in individuals with spinal cord injuries. In one study, a participant experienced long-lasting improvements in upper body function and sensation, suggesting that this non-invasive treatment can promote recovery and enhance quality of life. ^{1 2 3 4 5}

Is neuromodulation therapy for spinal cord injury safe?

Transcutaneous spinal stimulation has been shown to be generally safe in humans, with no major complications reported in studies. It was well-tolerated in children with spinal cord injuries, although one child experienced pain and another had a temporary issue with blood pressure during the treatment. ^{3 6 7 8 9}

How is the Transcutaneous Spinal Stimulator treatment different from other treatments for spinal cord injury?

The Transcutaneous Spinal Stimulator is unique because it is a non-invasive treatment that uses electrical stimulation to activate sensory fibers in the spinal cord, promoting motor recovery and reducing pain without the need for surgery or narcotic medications. This approach is different from traditional treatments as it can be easily applied and avoids major complications. ^{1 2 3 10 11}

Research Team

Andrea L Behrman, PT, PhD

Principal Investigator

University of Louisville

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

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]

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]

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]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Spinal Cord Stimulation Efficacy and Erroneous Conclusions of the Cochrane Library Review of Spinal Cord Stimulation for Low Back Pain by Traeger et al. [2023]

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

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

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

Transcutaneous electrical neurostimulation in musculoskeletal pain of acute spinal cord injuries. [2019]

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

Advances in Spinal Cord Neuromodulation: The Integration of Neuroengineering, Computational Approaches, and Innovative Conceptual Frameworks. [2023]

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

Transcutaneous Electrical Spinal Stimulation Promotes Long-Term Recovery of Upper Extremity Function in Chronic Tetraplegia. [2020]

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

Are there a guidelines for implantable spinal cord stimulator therapy in patients using chronic anticoagulation therapy? - A review of decision-making in the high-risk patient. [2020]

7. England pubmed.ncbi.nlm.nih.gov

Noninvasive spinal stimulation safely enables upright posture in children with spinal cord injury. [2022]

8. 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]

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

Best Practices in Spinal Cord Stimulation. [2021]

10. England pubmed.ncbi.nlm.nih.gov

Combined neuromodulatory approaches in the central nervous system for treatment of spinal cord injury. [2023]

11. Switzerland pubmed.ncbi.nlm.nih.gov

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