Spinal Cord Stimulation for Spasticity

Recruiting at 1 trial location

Overseen By Nilanjana Datta, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Miami

Must not be taking: Botulinum toxin

Disqualifiers: Severe neuropathic pain, Depression, Stroke, 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: Unknown

Duration: 4 months

6 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how spinal cord stimulation, combined with task practice, can reduce spasticity (muscle stiffness) in people with chronic spinal cord injuries. The researchers aim to determine if higher frequencies of stimulation improve movement and reduce muscle tightness. They seek participants who have had a stable cervical spinal cord injury for at least a year and experience muscle stiffness affecting daily activities in their arms. As an unphased trial, this study offers participants the chance to contribute to groundbreaking research that could enhance treatment options for spinal cord injuries.

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

The trial requires that your medication profile be stable for at least 4 weeks before enrolling. You must also be able to reduce your Baclofen dose to 30 mg or less daily. Other than that, the protocol does not specify if you need to stop other medications.

What prior data suggests that transcutaneous spinal cord stimulation is safe for spasticity?

Studies have shown that transcutaneous spinal cord stimulation (tSCS) is generally safe and well-tolerated by people with spinal cord injuries. Research indicates that this treatment can improve movement without causing serious side effects. Most participants report only slight discomfort during sessions, and serious problems are rare. This suggests that tSCS could be a safe option for managing muscle stiffness in individuals with long-term spinal injuries. Prospective participants can find reassurance in previous research supporting the safety of this approach. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for spasticity, which often involve medications like baclofen or botulinum toxin injections to relax muscles, Task Practice combined with Transcutaneous Spinal Cord Stimulation offers a novel approach. This treatment is unique because it directly stimulates the cervical spinal cord through the skin, potentially enhancing muscle control and reducing spasticity without invasive surgery. Researchers are excited about this technique because it could improve functional outcomes by pairing physical task practice with targeted spinal stimulation, offering a non-invasive alternative that might deliver faster and more sustained relief.

What evidence suggests that task practice combined with transcutaneous spinal cord stimulation is effective for spasticity?

Research shows that transcutaneous spinal cord stimulation (tSCS) can improve movement in people with long-term spinal cord injuries. In this trial, participants will receive combined transcutaneous cervical spinal cord stimulation with task practice. Studies have found that combining tSCS with specific exercises leads to greater improvements. For instance, regular use of tSCS has been linked to better muscle control and reduced muscle stiffness. One study discovered that 30 minutes of tSCS aimed at reducing stiffness improved both muscle activity and nervous system function. Overall, tSCS appears promising for reducing muscle stiffness and enhancing movement in people with spinal cord injuries. ^{1 2 4 6 7}

Who Is on the Research Team?

James Guest, MD, PhD

Principal Investigator

University of Miami

Are You a Good Fit for This Trial?

This trial is for adults aged 22-70 with non-progressive cervical spinal cord injury, at least a year post-injury. Participants must have some hand function (GRASSP score ≥10) and moderate to severe spasticity but not the most extreme form (MAS Score between 3 and <6). They should be able to lower Baclofen dosage to ≤30 mg daily, commit time-wise, and provide consent. Exclusions include other neurological diseases or conditions that could interfere with the study.

Inclusion Criteria

I can lower my Baclofen dose to 30 mg or less daily.

I am between 22 and 70 years old.

My hand function score is 10 or higher.

Exclusion Criteria

I have had transverse myelitis.

I have a history of neurological conditions like stroke or epilepsy.

Presence of syringomyelia as determined by MRI

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive combined transcutaneous cervical spinal cord stimulation with task practice

4 months

Follow-up

Participants are monitored for changes in spasticity and motor performance

2 months

What Are the Treatments Tested in This Trial?

Interventions

• Task Practice combined with Transcutaneous Spinal Cord Stimulation

Trial Overview The study tests how task practice combined with transcutaneous cervical spinal cord stimulation affects motor function and spasticity in individuals with chronic spinal cord injury. It specifically looks at whether higher frequencies of stimulation can reduce muscle stiffness/hypertonicity.

How Is the Trial Designed?

Group I: Task Practice with stimulation Experimental Treatment 1 Intervention

Participants in this group will receive combined Transcutaneous cervical spinal cord stimulation with task practice for up to 2 months.

Task Practice combined with Transcutaneous Spinal Cord Stimulation is already approved in United States, European Union for the following indications:

Approved in United States as Transcutaneous Spinal Cord Stimulation for:

• Spinal cord injury rehabilitation
• Motor function improvement
• Spasticity management

Approved in European Union as Transcutaneous Spinal Cord Stimulation for:

• Spinal cord injury rehabilitation
• Motor function improvement
• Spasticity management

Who Is Running the Clinical Trial?

University of Miami

Lead Sponsor

Trials

976

Recruited

423,000+

ONWARD Medical, Inc.

Industry Sponsor

Trials

5

Recruited

110+

United States Department of Defense

Collaborator

Trials

940

Recruited

339,000+

Published Research Related to This Trial

Transcutaneous spinal cord stimulation (tSCS) showed promise in reducing lower-limb spasticity in three subjects with chronic motor-incomplete spinal cord injury, with significant decreases in exaggerated reflex responsiveness and non-functional co-activation during movement.

Two out of three participants experienced a 39% increase in gait speed after tSCS, indicating potential clinical benefits for improving mobility without compromising existing motor control.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Modification of spasticity by transcutaneous spinal cord stimulation in individuals with incomplete spinal cord injury. Hofstoetter, US., McKay, WB., Tansey, KE., et al.[2021]

Transcutaneous spinal cord stimulation (tSCS) can non-invasively enhance sensorimotor rehabilitation by modulating spinal cord circuitry, showing promise for improving recovery after spinal cord injuries.

Single-site tSCS can influence excitability across multiple spinal cord segments, while multi-site tSCS can enhance spinal reflexes and corticospinal networks, indicating its potential for more effective rehabilitation strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neural Substrates of Transcutaneous Spinal Cord Stimulation: Neuromodulation across Multiple Segments of the Spinal Cord. Barss, TS., Parhizi, B., Porter, J., 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]

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]

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]

Transcutaneous Spinal Cord Stimulation (TSCS) can enhance the excitability of spinal neural circuits, which may improve voluntary performance in patients with incomplete spinal cord injuries (iSCI).

Combining TSCS with therapeutic interventions has the potential to accelerate recovery outcomes, although there is currently a gap in applying this knowledge to clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Utility and Feasibility of Transcutaneous Spinal Cord Stimulation for Patients With Incomplete SCI in Therapeutic Settings: A Review of Topic. Martin, R.[2022]

Transcutaneous spinal cord stimulation (SCS) significantly reduced spasticity in 12 individuals with spinal cord injury, showing immediate and lasting effects on measures like the Modified Ashworth Scale and clonus after a single 30-minute session.

A follow-up study over 6 weeks indicated that self-administered transcutaneous SCS could lead to progressive improvements in spasticity, suggesting it may be an effective non-invasive treatment option for managing spasticity in patients with spinal cord injuries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcutaneous Spinal Cord Stimulation Induces Temporary Attenuation of Spasticity in Individuals with Spinal Cord Injury. Hofstoetter, US., Freundl, B., Danner, SM., et al.[2021]

In a study of 13 patients with post-stroke spastic hemiparesis, spinal cord stimulation (SCS) led to significant improvements in motor performance for 8 patients, as confirmed by both clinical evaluations and EMG analysis.

The improvements included better coordination of muscle activity, reduced clonus, and enhanced endurance, with effects lasting up to 2 years, suggesting that SCS may enhance sensory input and promote new sensory-motor integration, which is crucial for motor recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Spinal cord stimulation (SCS) in spastic hemiparesis. Cioni, B., Meglio, M., Prezioso, A., et al.[2019]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10274551/

Transcutaneous spinal cord stimulation effects on spasticity ... Transcutaneous spinal cord stimulation (tSCS) has demonstrated motor function improvements following SCI. No systematic reviews were published examining the ...

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. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11604492/

Transcutaneous spinal cord stimulation neuromodulates pre We show that 30 min of antispasticity TSCS improves activity in post- and presynaptic inhibitory circuits beyond the intervention in ten ...

4. physoc.onlinelibrary.wiley.com physoc.onlinelibrary.wiley.com/doi/full/10.1113/JP287100

Transcutaneous spinal cord stimulation at alternating ... Transcutaneous spinal cord stimulation (tSCS) has shown potential for targeting and improving spasticity after spinal cord injury (SCI) in both ...

5. researchprotocols.org researchprotocols.org/2025/1/e80995/PDF

Effectiveness of Transcutaneous Spinal Cord Stimulation ... The primary outcome will be lower limb motor function assessed by validated measures such as the Lower Extremity Motor Score. Secondary outcomes ...

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

Safety and Effectiveness of Multisite Transcutaneous ... Objective: Evaluate the preliminary safety and efficacy of multi-site transcutaneous spinal cord stimulation (tSCS) combined with activity-based ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT06494020

NCT06494020 | Task Practice and Spinal Cord Stimulation Transcutaneous stimulation has been shown to improve motor function in some individuals with chronic spinal cord injury. The study intends to explore ...