Spinal Cord Stimulation for Spinal Cord Injury

Overseen By Clare Morey, MA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Craig Hospital

Must not be taking: Botox

Disqualifiers: Cardiac, Respiratory, Fractures, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 27

Duration: 8 weeks

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether transcutaneous spinal cord stimulation (TSCS) can improve movement and strength in individuals with recent spinal cord injuries. Researchers are testing if combining TSCS with exoskeleton training is more effective than exoskeleton training alone. They will measure improvements in walking, strength, trunk control, and bowel and bladder function. Individuals with an incomplete spinal cord injury within the last 12 months who can walk slowly might be suitable candidates. Participants will undergo 24 training sessions and several evaluations to assess the treatments' effectiveness. As an unphased trial, this study offers the chance to contribute to groundbreaking research that could enhance rehabilitation strategies for spinal cord injuries.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. Please consult with the trial coordinators for more details.

What prior data suggests that transcutaneous spinal cord stimulation is safe for individuals with spinal cord injury?

Research has shown that transcutaneous spinal cord stimulation (TSCS) is generally safe for people with spinal cord injuries. Studies have found that many individuals tolerate multiple TSCS sessions well. Some reports mention improvements in function without serious side effects. In certain studies, participants noticed benefits after several TSCS sessions. Although no severe side effects have been reported, discussing potential risks with a doctor before joining a trial is important. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Transcutaneous Spinal Cord Stimulation (TSCS) is unique because it uses electrical currents to stimulate the spinal cord externally, which is different from traditional treatments like surgery or medication that often focus on pain management or inflammation reduction. Unlike standard options that might involve invasive procedures, TSCS is non-invasive and can be combined with physical aids like an exoskeleton to enhance mobility. Researchers are excited about TSCS because it has the potential to improve motor function and quality of life for individuals with spinal cord injuries by directly targeting and activating neural circuits responsible for movement.

What evidence suggests that transcutaneous spinal cord stimulation combined with exoskeleton training could be effective for improving motor function in individuals with incomplete spinal cord injury?

Research has shown that transcutaneous spinal cord stimulation (TSCS) can improve mobility in people with spinal cord injuries. In past studies, over 70% of participants experienced noticeable improvements in movement after receiving TSCS. For some, these benefits appeared after at least 60 sessions combined with other therapies. This trial will compare two treatment arms: one where participants receive TSCS while using an exoskeleton, and another where participants use an exoskeleton with sham stimulation. This non-invasive method uses electrical currents to stimulate the spinal cord, potentially increasing strength and control in the legs and body. The encouraging results suggest that TSCS could be an important tool for helping people with spinal cord injuries regain mobility. ^{2 3 4 5 6}

Are You a Good Fit for This Trial?

This trial is for individuals under 12 months post-traumatic incomplete spinal cord injury (iSCI) between C4-T10, who can walk but slower than 1.46 m/s. They must be adults weighing no more than 220lbs with intact skin where the device will sit and have enough upper body strength to use a stability aid.

Inclusion Criteria

I am medically cleared for intense walking exercises.

I weigh 220lbs or less.

I had a spinal cord injury between C4-T10 less than 12 months ago with upper motor neuron signs.

Exclusion Criteria

Pregnancy

Any other issue that in the opinion of the investigator would impact study participation

Non-English Speaking

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Evaluation

Participants undergo a baseline evaluation to assess initial motor function and other parameters

1 week

1 visit (in-person)

Treatment

Participants receive 24, 1-hour training sessions at Craig Hospital, either with exoskeleton training combined with TSCS or exoskeleton training with sham stimulation

8 weeks

24 visits (in-person)

Post-treatment Evaluation

Participants undergo a post-treatment evaluation to assess changes in motor function and other parameters

1 week

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with a follow-up evaluation four weeks after training is completed

4 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Transcutaneous Spinal Cord Stimulation

Trial Overview Researchers are testing if adding transcutaneous spinal cord stimulation (TSCS) to exoskeleton training helps improve walking, strength, muscle control, trunk balance, and bladder function better than exoskeleton training alone in those with iSCI.

How Is the Trial Designed?

Group I: Exoskeleton+Transcutaneous Spinal Cord Stimulation Experimental Treatment 1 Intervention

Treatment in this group will involve walking overground using the assistance of an exoskeleton while receiving a therapeutic level of transcutaneous spinal cord stimulation (TSCS) thoracolumbar spinal cord areas. Focus will be on stepping at a high intensity throughout the session as measured by heart rate.

Group II: Exoskeleton+Sham Stimluation Placebo Group 1 Intervention

Treatment in this group will involve walking overground using the assistance of an exoskeleton while receiving a non-therapeutic level of stimulation (considered to be a sham). Focus will be on stepping at a high intensity throughout the session as measured by heart rate.

Who Is Running the Clinical Trial?

Craig Hospital

Lead Sponsor

Trials

45

Recruited

8,400+

Published Research Related to This Trial

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]

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]

Transcutaneous spinal cord stimulation (tSCS) can enhance muscle recruitment selectivity when using multielectrode configurations, as shown in a study with 16 participants, which may improve rehabilitation outcomes for paralyzed muscles after spinal cord injury.

The study found that spatially selective tSCS activates specific motor neurons through proprioceptive fibers, indicating a mechanism that could lead to more effective rehabilitation protocols targeting single-joint movements.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Enhanced selectivity of transcutaneous spinal cord stimulation by multielectrode configuration. Bryson, N., Lombardi, L., Hawthorn, R., 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]

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 analyzing 2053 cases of cervical spinal cord stimulation (cSCS) from 2002 to 2011, the rate of spinal cord injury was found to be 0.5%, which is higher than previously reported, indicating a need for careful patient selection and counseling.

Despite the spinal cord injury rate, cSCS remains a relatively safe procedure with low rates of other complications (1.1% neurological, 1.4% medical, and 11.7% general perioperative complications), making it a viable option for pain management in patients, especially in an aging population reliant on opioids.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rate of perioperative neurological complications after surgery for cervical spinal cord stimulation. Chan, AK., Winkler, EA., Jacques, L.[2017]

In a study of 69 patients with implanted spinal cord stimulators (SCSs) who underwent 78 MRI scans, the overall adverse event rate for off-label MRI use was low at 9.72%, with no serious adverse events reported.

All reported clinical adverse events were minor and resolved, suggesting that the benefits of MRI for pain management in patients with older SCS models may outweigh the associated risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Off-Label Magnetic Resonance Imaging (MRI) in Patients with Persistent Pain with Spinal Cord Stimulators: A Case Series. Ragukonis, T.[2022]

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]

In a double-blinded study involving 2 male patients with incomplete spinal cord injury, anodal transcutaneous spinal direct current stimulation (tsDCS) improved all measured outcomes, including gait and balance, while cathodal tsDCS showed mixed results.

Both types of tsDCS were able to modulate corticospinal excitability, indicating that this non-invasive method could be a promising approach for enhancing rehabilitation in patients with spinal cord injuries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Spinal direct current stimulation with locomotor training in chronic spinal cord injury. Abualait, TS., Ibrahim, AI.[2021]

Citations

1. 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)

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. researchprotocols.org researchprotocols.org/2025/1/e80995

Effectiveness of Transcutaneous Spinal Cord Stimulation ... Objective: This systematic review and meta-analysis will determine the effectiveness of tSCS, compared with sham stimulation, no intervention, ...

4. 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 ...

5. 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) ...

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 ...