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

Trial Summary

What is the purpose of this trial?

This trial tests a new therapy using mild electrical stimulation and exercises to help children with neck spinal cord injuries improve their arm and hand movements. The goal is to make it easier for these children to play and do everyday tasks. This approach has been shown to increase independence and reduce the need for help and special equipment in children and adolescents with spinal cord injuries.

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 data supports the idea that Transcutaneous Spinal Stimulation for Spinal Cord Injury is an effective treatment?

The available research shows that Transcutaneous Spinal Stimulation (tSCS) can help people with spinal cord injuries improve their ability to move. Studies have found that tSCS can activate muscles in both the upper and lower parts of the body, leading to better voluntary movement, muscle strength, and function. For example, one review found that all studies included showed increased muscle activity and strength in participants with spinal cord injuries. This suggests that tSCS is a promising treatment for improving motor function in these individuals. ^{1 2 3 4 5}

What safety data is available for transcutaneous spinal stimulation for spinal cord injury?

The safety data for transcutaneous spinal stimulation (tSCS) is not explicitly detailed in the provided research abstracts. However, the studies reviewed indicate that tSCS is a non-invasive method used to facilitate motor responses and improve motor function in individuals with spinal cord injury. The systematic review of tSCS studies included 55 participants and reported induced muscle activation and improvements in voluntary movement, muscle strength, and function. While these studies suggest tSCS is a feasible therapeutic strategy, they emphasize the need for more statistically powered and controlled clinical trials to fully understand its safety and efficacy. The abstracts do not report specific adverse events or safety concerns, indicating a need for further research to establish comprehensive safety data. ^{1 2 3 6 7}

Is the treatment Biostim-5 transcutaneous spinal stimulator a promising treatment for spinal cord injury?

Yes, the Biostim-5 transcutaneous spinal stimulator is a promising treatment for spinal cord injury. It is a non-invasive method that uses electrodes to stimulate the spinal cord, helping to improve movement and muscle strength in people with spinal cord injuries. Studies have shown that it can enhance voluntary movement and function in both the upper and lower limbs. ^{1 2 3 4 5}

Research Team

Andrea L Behrman, PT, PhD

Principal Investigator

University of Louisville

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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 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]

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]

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]

References

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

Transcutaneous spinal cord stimulation and motor responses in individuals with spinal cord injury: A methodological review. [2022]

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 Spinal Cord Stimulation and Motor Rehabilitation in Spinal Cord Injury: A Systematic Review. [2021]

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

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

5. Netherlands pubmed.ncbi.nlm.nih.gov

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

6. United States 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. [2022]

7. United States 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. [2023]