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

Trial Summary

What is the purpose of this trial?

This trial aims to see how different types of noninvasive electrical stimulation affect muscle issues and pain in people with spinal cord injuries. The treatment involves placing electrodes on the skin to send electrical pulses to the spine. Researchers hope to find the best way to use these pulses to reduce muscle problems and pain.

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

Research shows that Transcutaneous Spinal Stimulation (TSS) can help improve muscle activation and voluntary movement in people with spinal cord injuries. Studies have found that TSS can enhance motor function in both the upper and lower limbs, suggesting it may be a promising non-invasive treatment option. ^{1 2 3 4 5}

Is spinal stimulation for spinal cord injury generally safe for humans?

The safety of spinal stimulation for spinal cord injury is not well-documented in the provided research articles, which focus on adverse events in spinal cord injury care and the quality of safety reporting in clinical trials. Comprehensive safety data specific to spinal stimulation is not available in these studies. ^{6 7 8 9 10}

How is Transcutaneous Spinal Stimulation (TSS) different from other treatments for spinal cord injury?

Transcutaneous Spinal Stimulation (TSS) is unique because it is a non-invasive treatment that uses electrodes placed on the skin to stimulate the spinal cord, promoting motor function and muscle activation without surgery. Unlike other treatments, TSS can enhance voluntary movement and muscle strength by activating spinal circuitries, making it a promising alternative to more invasive methods like epidural stimulation. ^{1 3 4 11 12}

Research Team

Edelle C Field-Fote, PT, PhD

Principal Investigator

Shepherd Center, Atlanta GA

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

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]

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]

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]

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]

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]

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 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]

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]

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]

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]

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. Switzerland pubmed.ncbi.nlm.nih.gov

Transcutaneous Electrical Spinal Cord Stimulation to Promote Recovery in Chronic Spinal Cord Injury. [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. United States pubmed.ncbi.nlm.nih.gov

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

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

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

6. Switzerland pubmed.ncbi.nlm.nih.gov

Epidemiology of Traumatic Spinal Cord Injury in Ireland, 2010-2015. [2019]

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

Incidence of acute care adverse events and long-term health-related quality of life in patients with TSCI. [2015]

8. United States 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. [2019]

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

Traumatic spinal injury-related hospitalizations in the United States, 2016-2019: a retrospective study. [2023]

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

A Systematic Review of Safety Reporting in Acute Spinal Cord Injury Clinical Trials: Challenges and Recommendations. [2023]

11. England pubmed.ncbi.nlm.nih.gov

Effects of transcutaneous spinal stimulation on spatiotemporal cortical activation patterns: a proof-of-concept EEG study. [2022]

12. Switzerland pubmed.ncbi.nlm.nih.gov

Adapting Human-Based Transcutaneous Spinal Cord Stimulation to Develop a Clinically Relevant Animal Model. [2023]