Transcutaneous Spinal Stimulation for Spinal Cord Injury

Overseen By Lisa Clayton, B.S.

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Louisville

Must not be taking: Botox, Baclofen

Disqualifiers: Unhealed fracture, Congenital SCI, 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: 40

Duration: 8 weeks

10 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new therapy to help children with spinal cord injuries in the neck area improve hand and arm movements. The therapy uses the Biostim-5 transcutaneous spinal stimulator, which stimulates the spinal cord and works with exercises to enhance abilities like grasping and reaching. It targets children who have had a spinal cord injury for over a year and struggle with tasks like reaching overhead or pinching. The goal is to make everyday activities easier and more like they were before the injury. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could significantly improve daily life for children facing similar challenges.

Do I have to stop taking my current medications for the trial?

The trial requires that you stop using baclofen and not have used botox in the past 3 months.

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

Research has shown that the Biostim-5 device is generally safe for children with spinal cord injuries. Studies have found this type of spinal stimulation to be both safe and practical for these children. For example, short-term use of the device on certain parts of the spine was well-tolerated, with no serious side effects reported.

One study found that this therapy improved hand function without causing major problems. Most children experienced only minor issues, such as temporary skin irritation from the electrodes, which is common with these devices. Overall, the treatment has been tested in similar situations and found safe for children with spinal cord injuries. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard of care for spinal cord injury, which often involves physical therapy and medication to manage symptoms, the Biostim-5 transcutaneous spinal stimulator offers a non-invasive approach that delivers electrical stimulation through the skin. This technique is unique because it targets the spinal cord directly, potentially enhancing nerve activity and improving upper extremity function. Researchers are excited about this treatment as it could offer faster improvements in hand and arm use while being less invasive and more accessible than surgical options.

What evidence suggests that the Biostim-5 transcutaneous spinal stimulator is effective for spinal cord injury?

Research has shown that transcutaneous spinal cord stimulation (tSCS), which participants in this trial will receive, can improve strength and movement. This technique uses electrical signals to enhance control of the arms and hands, benefiting those with spinal cord injuries. Studies have found that this stimulation can enhance hand function and even improve walking in some individuals. Specifically, early results suggest that tSCS can help children with neck spinal cord injuries regain some use of their hands and arms. When combined with exercises, it may significantly improve everyday tasks like grasping and reaching. ^{6 7 8 9 10}

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 with chronic spinal cord injuries in the neck or high thoracic area, who have been injured for over a year and struggle to use their arms and hands. They should be past in-patient rehab but not using certain muscle relaxants or have unhealed fractures.

Inclusion Criteria

I have difficulty using my arms for tasks like reaching overhead or grasping.

I have had a spinal cord injury for over a year.

My spinal cord injury is in the neck or upper back area.

Exclusion Criteria

You rely completely on a ventilator for breathing.

You were born with a spinal cord injury.

I have no health issues preventing me from joining in physical assessments or arm exercises.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo transcutaneous spinal stimulation combined with activity-based upper extremity training for 40 sessions

8 weeks

40 sessions (in-person), 5 days/week

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Biostim-5 transcutaneous spinal stimulator

Trial Overview The trial tests a new therapy using the Biostim-5 device to stimulate the spinal cord while kids practice movements like grasping and reaching. The aim is to see if it's safe, comfortable, and practical for improving arm function.

How Is the Trial Designed?

Group I: Transcutaneous spinal stimulation - Acute and Training Experimental Treatment 1 Intervention

Safety and feasibility outcome measures are collected during application of transcutaneous spinal stimulation while upper extremity function is assessed at 3 time points (acute) and/or in combination with activity-based upper extremity training (40 sessions, 1.5 hours/day, 5 days/week); stimulation will be applied intermittently for no more than 10 minutes at a time. Upper extremity training is based on usual care activities to challenge use of the hands and arms, e.g. reaching, grasping, manipulating objects.

Biostim-5 transcutaneous spinal stimulator is already approved in United States, European Union for the following indications:

Approved in United States as Biostim-5 transcutaneous spinal stimulator for:

• Spinal cord injury rehabilitation
• Upper limb function improvement

Approved in European Union as Transcutaneous Spinal Cord Stimulation (tSCS) for:

• Spinal cord injury rehabilitation
• Pain relief
• Motor function improvement

Who Is Running the Clinical Trial?

University of Louisville

Lead Sponsor

Trials

353

Recruited

76,400+

The Jewish Heritage Foundation for Excellence

Collaborator

Trials

1

Recruited

10+

Published Research Related to This Trial

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]

Transcutaneous spinal cord stimulation (TSCS) therapy significantly altered brain activity related to bladder function in stroke patients with lower urinary tract dysfunction (LUTD), making their brain activity patterns more similar to those of healthy individuals.

After 24 sessions of TSCS, patients showed clinically meaningful improvements in urinary function, as indicated by validated questionnaires and voiding diaries, highlighting TSCS as a promising treatment for LUTD following stroke.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Pilot Study of the Effect of Transcutaneous Spinal Cord Stimulation on Micturition-Related Brain Activity and Lower Urinary Tract Symptoms After Stroke. Kreydin, EI., Abedi, A., Montero, VS., et al.[2023]

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]

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]

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]

Spinal cord stimulation (SCS) is effective in improving pain relief, sleep quality, and functional activities in patients with chronic pain, as shown by a survey of 30 patients who reported positive outcomes after receiving different SCS devices.

While there were no significant differences in pain relief and sleep improvement among the three SCS device manufacturers (Medtronic, Advanced Bionics, and ANS), the Advanced Bionics group showed less functional improvement compared to the other two groups, suggesting that device technology may influence certain outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of spinal cord stimulation, overall, and the effect of differing spinal cord stimulation technologies on pain, reduction in pain medication, sleep, and function. Haddadan, K., Krames, ES.[2022]

Citations

1. mdpi.com mdpi.com/2077-0383/10/15/3278

Transcutaneous Electrical Neuromodulation of the Cervical ... Electrical enabling motor control (eEmc) through transcutaneous spinal cord stimulation offers promise in improving hand function.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12469035/

Non-Invasive Cervical Spinal Stimulation and Respiratory ... Recent evidence suggests that transcutaneous electrical spinal cord stimulation (tSCS) may enhance motor strength and promote functional ...

3. withpower.com withpower.com/trial/phase-spinal-cord-injuries-7-2021-9febb

Non-invasive Spinal Stimulation for Spinal Cord Injury This trial tests a combination of exercises and electrical stimulation to improve sitting and trunk control in children with severe spinal injuries.

4. biomedical-engineering-online.biomedcentral.com biomedical-engineering-online.biomedcentral.com/articles/10.1186/s12938-024-01231-1

Noninvasive spinal stimulation improves walking in chronic ... This case series study aims to investigate the effectiveness of transcutaneous spinal cord stimulation (tSCS) in enhancing walking ability of persons with ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT05731986

Spinal Cord Transcutaneous Stimulation Effect on Blood ... The objective of this study is to investigate the effect of spinal cord transcutaneous stimulation (scTS) on BP in individuals with an acute/sub-acute SCI (7-30 ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10452666/

Transcutaneous Spinal Cord Stimulation Improves ... Transcutaneous spinal cord stimulation improves respiratory muscle strength and function in subjects with cervical spinal cord injury.

7. neuromodulationjournal.org neuromodulationjournal.org/article/S1094-7159(23)00648-7/fulltext

Safety and Feasibility of Cervical and Thoracic ... Safety and feasibility of cervical and thoracic transcutaneous spinal cord stimulation to improve hand motor function in children with chronic spinal cord ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S1094715923006487

Safety and Feasibility of Cervical and Thoracic ... We indicated that short-term application of scTS via two cervical and one thoracic site is safe and feasible in children with SCI and resulted in immediate ...

9. mdpi.com mdpi.com/2227-9059/11/2/589

Transcutaneous Cervical Spinal Cord Stimulation ... The aim of the study was to determine the effects of cervical tSCS, combined with an exoskeleton, on motor strength and functionality of UE in subjects with ...

10. clinicaltrials.ucsf.edu clinicaltrials.ucsf.edu/trial/NCT07090473

UCSF Spinal Cord Injury Trial → Transcutaneous Electrical ... The goal of this study is to test whether electrical stimulation from the skin surface starting 3 days after spinal cord injury (SCI) is ...