Spinal Stimulation for Spinal Cord Injury

Overseen By Jaclyn Miller, PT, DPT

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Shepherd Center, Atlanta GA

Disqualifiers: Neurological problems, Heart issues, Pregnancy, 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: 6

Duration: 2-3 weeks

36 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how different types of electrical spinal stimulation, including Transcutaneous Spinal Stimulation (TSS), affect muscle spasms, strength, and pain in individuals with a spinal cord injury. The treatment applies electrical stimulation through electrodes on the skin of the lower back and stomach. Researchers aim to determine if this can reduce muscle spasms and improve strength. Participants should have had a spinal cord injury for at least three months, experience muscle spasms in their legs, and be able to follow instructions and communicate discomfort. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could enhance the quality of life for those with spinal cord injuries.

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications, but you must inform the investigators if there is any change in your medications during the study.

What prior data suggests that this spinal stimulation is safe for spinal cord injury?

Research shows that transcutaneous spinal stimulation is generally safe for people with spinal cord injuries. This electrical stimulation, applied through pads on the skin, is well-tolerated by many patients. In past studies, participants underwent many sessions with few reports of serious side effects. Most experienced only mild skin irritation where the pads were placed.

This treatment has also been used to improve arm and hand function in those with spinal cord injuries. Various studies support the safety and effectiveness of this approach, with many participants seeing improvements in their condition without major side effects.

This treatment is noninvasive, meaning it doesn't involve surgery or entering the body, which often makes it safer compared to more invasive procedures. Participants considering this treatment should feel encouraged by the existing research but should always discuss any concerns with their healthcare providers. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Transcutaneous Spinal Stimulation is unique because it offers a non-invasive approach to treating spinal cord injuries, unlike traditional options like surgery or medication. This technique uses electrical pulses delivered through the skin to stimulate the spinal cord, potentially enhancing nerve function and motor recovery. Researchers are excited about this method as it explores different frequency settings—30 Hz, 50 Hz, and 80 Hz—which could optimize recovery outcomes and provide personalized treatment options for patients.

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

Research has shown that transcutaneous spinal stimulation (tSCS) can aid individuals with spinal cord injuries. Studies have found that this technique can enhance motor recovery, helping people regain movement. In one study, about 72% of participants demonstrated significant improvements in moving their arms and legs. This trial will test different frequencies of tSCS, with participants receiving either 30 Hz, 50 Hz, or 80 Hz frequency stimulation. Another study found that combining tSCS with other therapies led to even better recovery, although it required many sessions. Overall, these findings suggest that tSCS might help reduce muscle problems and improve strength and function for those with spinal cord injuries. ^{2 3 4 5 6}

Who Is on the Research Team?

Edelle C Field-Fote, PT, PhD

Principal Investigator

Shepherd Center, Atlanta GA

Are You a Good Fit for This Trial?

This trial is for individuals aged 16 or older who have had a spinal cord injury at least 3 months prior, with some leg spasticity. Participants should be able to follow instructions and communicate discomfort. They must consent to health information usage and report any changes in prescription medications during the study.

Inclusion Criteria

Participants must agree to allow use of health information

Participants must be able to communicate if pain or discomfort is experienced

I am 16 years old or older.

Exclusion Criteria

I currently have an infection.

People with neurological problems other than SCI

Women who are pregnant

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Baseline Testing

Participants undergo baseline testing for spasticity, strength, and pain before intervention

1 day

1 visit (in-person)

Treatment

Participants receive transcutaneous spinal stimulation (TSS) at varying frequencies for 2-3 weeks

2-3 weeks

4 visits per week (in-person)

Post-Treatment Testing

Participants undergo testing for spasticity, strength, and pain immediately after intervention

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Transcutaneous Spinal Stimulation

Trial Overview The study tests how different frequencies of noninvasive spinal stimulation affect muscle control, involuntary muscle activity (spasticity), and pain after a spinal cord injury. It involves electrical stimulation over the lower back and stomach, requiring visits to Shepherd Center for sessions across several weeks.

How Is the Trial Designed?

Group I: 80 Hz Frequency Experimental Treatment 1 Intervention

Intervention will be applied with an 80 Hz frequency.

Group II: 50 Hz Frequency Experimental Treatment 1 Intervention

Intervention will be applied with a 50 Hz frequency.

Group III: 30 Hz Frequency Experimental Treatment 1 Intervention

Intervention will be applied with a 30 Hz frequency.

Transcutaneous Spinal Stimulation is already approved in United States, European Union for the following indications:

Approved in United States as Transcutaneous Spinal Stimulation for:

• Spinal cord injury rehabilitation
• Improvement of walking function
• Reduction of spasticity

Approved in European Union as Transcutaneous Spinal Stimulation for:

• Spinal cord injury rehabilitation
• Improvement of walking function
• Reduction of spasticity

Who Is Running the Clinical Trial?

Shepherd Center, Atlanta GA

Lead Sponsor

Trials

30

Recruited

4,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Trials

2,103

Recruited

2,760,000+

Published Research Related to This Trial

A new animal model for transcutaneous spinal cord stimulation (tSCS) was developed, which accurately mimics human responses and allows for stable, repeated treatments after spinal cord injury (SCI) with minimal restraint.

The study demonstrated that tSCS can effectively modulate motor output in rats after complete spinal cord transection, suggesting its potential for promoting neuroplasticity and functional recovery in SCI.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adapting Human-Based Transcutaneous Spinal Cord Stimulation to Develop a Clinically Relevant Animal Model. Malloy, DC., Knikou, M., Côté, MP.[2023]

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 spinal cord stimulation (TSS) significantly affects brain activity, activating key areas related to movement control and planning, as shown by EEG analysis in five participants performing lower-limb tasks.

TSS resulted in notable changes in functional connectivity in the brain during stimulation, unlike functional electrical stimulation (FES), suggesting TSS may be more effective for enhancing cortical engagement in rehabilitation strategies for spinal cord injury.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of transcutaneous spinal stimulation on spatiotemporal cortical activation patterns: a proof-of-concept EEG study. Steele, AG., Manson, GA., Horner, PJ., et al.[2022]

In a study of 444 adults with traumatic spinal cord injury, 79.3% experienced adverse events, with urinary tract infections and pneumonia being the most common, highlighting the high risk of complications in this patient group.

Older age and more severe injuries were linked to increased adverse events, while certain modifiable comorbidities, like substance use and psychiatric conditions, were associated with specific risks such as delirium and pneumonia, suggesting that addressing these factors could help reduce complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Previously Identified Common Post-Injury Adverse Events in Traumatic Spinal Cord Injury-Validation of Existing Literature and Relation to Selected Potentially Modifiable Comorbidities: A Prospective Canadian Cohort Study. Marion, TE., Rivers, CS., Kurban, D., et al.[2019]

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]

The incidence of traumatic spinal cord injury (TSCI) in Ireland remained stable at 11.5-13.3 per million per year from 2010 to 2015, with a mean age of injury onset at 48.9 years, predominantly affecting males (71.5%).

The most common type of injury was incomplete tetraplegia, which accounted for 43.2% of cases, and was more prevalent among older patients, indicating a need to reassess acute care and rehabilitation services for this demographic.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Epidemiology of Traumatic Spinal Cord Injury in Ireland, 2010-2015. Smith, E., Fitzpatrick, P., Murtagh, J., et al.[2019]

In a study of 171 patients with traumatic spinal cord injury (TSCI), over 77% experienced adverse events (AEs) during acute hospital care, with urinary tract infections and pneumonias being the most common, highlighting the need for improved monitoring and prevention strategies.

The presence of certain AEs, such as decubitus ulcers and delirium, significantly increased the length of hospital stay, indicating that these complications can lead to longer recovery times, although acute AEs did not impact health-related quality of life at the time of discharge.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Incidence of acute care adverse events and long-term health-related quality of life in patients with TSCI. Street, JT., Noonan, VK., Cheung, A., et al.[2015]

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]

In a study involving 31 patients with spinal cord injury, transcutaneous electrical nerve stimulation (TENS) was found to be more effective in treating pain directly at the injury site compared to radiating or central pain.

The results suggest that the location of pain significantly influences the success of TENS treatment, highlighting the need for targeted pain management strategies in spinal cord injury patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcutaneous nerve stimulation for treatment of pain in patients with spinal cord injury. Davis, R., Lentini, R.[2004]

From 2016 to 2019, the incidence of traumatic spinal injury (TSI) in the US increased to 48.4 per 100,000 persons, indicating a growing public health concern.

In-hospital mortality rates were notably high for spinal cord injury (SCI) cases, with 3.9% for those receiving surgery and 28% for nonoperative treatments, highlighting the severity of SCI-related TSIs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Traumatic spinal injury-related hospitalizations in the United States, 2016-2019: a retrospective study. Sun, J., Yuan, W., Zheng, R., et al.[2023]

Only 30% of the 40 reviewed clinical trials on acute spinal cord injury provided satisfactory reporting of adverse events, indicating a significant gap in safety information that is crucial for assessing risk and designing future studies.

A staggering 82.5% of trials failed to report laboratory-defined toxicity satisfactorily, highlighting the need for improved standards in safety reporting to ensure comprehensive understanding of treatment risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Systematic Review of Safety Reporting in Acute Spinal Cord Injury Clinical Trials: Challenges and Recommendations. Aspinall, P., Harrison, L., Scheuren, P., et al.[2023]

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 ... Combined tSCS + ABT facilitated functional recovery after chronic SCI. Improvements required ≥60 tSCS-ABT sessions, with further exposure to tSCS facilitating ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38958629/

Non-invasive Transcutaneous Spinal Cord Stimulation ... This study analyzes the stimulation parameters implemented during two successful trials that used non-invasive transcutaneous spinal cord stimulation (tSCS)

4. nature.com nature.com/articles/s41591-024-02940-9

Non-invasive spinal cord electrical stimulation for arm and ... Of the 60 participants included in the primary effectiveness endpoint analysis, 43 (72%) met or exceeded the minimally important difference (MID) ...

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

Transcutaneous Electrical Spinal Cord Stimulation to ... To evaluate the impact of using transcutaneous electrical spinal cord stimulation (TSCSTSCS) on upper and lower extremity function in individuals with chronic ...

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

Safety and Effectiveness of Multisite Transcutaneous ... Combined tSCS + ABT facilitated functional recovery after chronic SCI. Improvements required ≥60 tSCS-ABT sessions, with further exposure to tSCS facilitating ...