Spatiotemporal tSCS for Paralysis

Overseen By Carolyn Atkinson, BS

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Washington University School of Medicine

Disqualifiers: Pregnancy, Cardiopulmonary disease, Orthopedic conditions, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 8-12 weeks

48 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method of spinal cord stimulation that could help people with paralysis regain movement. The focus is on controlling the stimulation to target specific muscle groups more effectively than current methods. Researchers will divide participants into three groups: one with no stimulation, one with conventional stimulation, and one with the new spatiotemporal tSCS (transcutaneous spinal cord stimulation). Suitable candidates have a spinal cord injury from at least a year ago and can voluntarily move at least two leg muscles. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could transform paralysis treatment.

Do I need to stop my current medications for the trial?

The trial does not specify if you need to stop your current medications. However, it mentions that your prescription medication for spasticity should not have changed in the last 2 weeks, which might suggest you can continue them.

What prior data suggests that spatiotemporal tSCS is safe for spinal cord injury rehabilitation?

Research shows that spatiotemporal transcutaneous spinal cord stimulation (tSCS) may help people regain movement after spinal cord injuries. Previous studies have examined how this treatment can activate specific muscles and nerves. While research is ongoing, it provides some information about safety.

In one study using tSCS, most participants tolerated it well. The most common side effect was mild skin irritation at the electrode sites. No serious side effects were reported, suggesting the treatment is generally safe for many people.

Spatiotemporal tSCS is a more advanced version of regular tSCS, allowing for more precise muscle targeting, which might improve results. However, most safety information comes from studies on regular tSCS. Ongoing research is crucial to understanding any new risks or benefits.

In summary, current research suggests that tSCS is generally safe and well-tolerated. However, as with any medical treatment, potential participants should discuss any concerns with their healthcare provider. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about spatiotemporal tSCS because it offers a new way to help people with paralysis. Unlike conventional transcutaneous spinal cord stimulation (tSCS), which uses a single cathode and steady frequency, spatiotemporal tSCS varies the electrode placement, frequency, and intensity to better target and activate specific muscles. This method aims to enhance voluntary motor output and improve muscle control more effectively. By customizing the stimulation patterns, researchers hope to optimize muscle recruitment and improve movement outcomes for individuals with paralysis.

What evidence suggests that spatiotemporal tSCS could be effective for paralysis?

This trial will compare different approaches to transcutaneous spinal cord stimulation (tSCS) for paralysis. Research has shown that spatiotemporal tSCS, which participants in this trial may receive, can help people with spinal cord injuries regain movement. Studies have found that combining continuous tSCS with walking exercises improves walking ability. This stimulation activates brain areas involved in leg movement, offering promise for restoring mobility. Recent research highlights new ways to use spinal cord stimulation, demonstrating significant progress in methods to aid movement. Overall, spatiotemporal tSCS offers a hopeful approach to restoring movement in paralyzed individuals. ^{1 2 3 4 5}

Are You a Good Fit for This Trial?

This trial is for individuals with paralysis due to spinal cord injury. Participants should be adults who have stable medical conditions and are not currently pregnant. They must not have any implanted electronic devices, history of seizures, or skin issues at the stimulation site.

Inclusion Criteria

My spinal cord injury is between C3 and T12 and happened over a year ago.

I am between 16 and 65 years old.

My spinal injury is classified as moderate to mild (ASIA C or D).

Exclusion Criteria

I do not have severe pain, depression, or cognitive issues that could affect exercise or brain tests.

Pregnant, planning to become pregnant, or currently breastfeeding

Implanted stimulators of any type (baclofen pump, epidural spinal stimulator, cardiac defibrillator, pace-maker, etc.)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants perform leg movements using different stimulation parameter configurations in non-invasive tSCS

8-12 weeks

Weekly sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Spatiotemporal tSCS

Trial Overview

The study explores three approaches: no stimulation as a control, conventional transcutaneous spinal cord stimulation (tSCS), and an advanced version called spatiotemporal tSCS that aims to better target muscle groups and neural pathways.

How Is the Trial Designed?

Group I: Spatiotemporal tSCS Experimental Treatment 1 Intervention

Participants complete the same tasks and assessments while receiving spatiotemporal tSCS in which stimulation parameters are systematically varied across sessions, including electrode location/configuration (spatial control), frequency, and amplitude (temporal/intensity control), to optimize targeted muscle recruitment and voluntary motor output.

Group II: No stimulation Experimental Treatment 1 Intervention

Participants complete the study motor tasks and assessments without transcutaneous spinal cord stimulation (tSCS).

Group III: Conventional tSCS Active Control 1 Intervention

Participants complete the same experimental tasks and assessments while receiving conventional, non-invasive transcutaneous spinal cord stimulation (tSCS) using a single cathode and 30 Hz.

Who Is Running the Clinical Trial?

Washington University School of Medicine

Lead Sponsor

Trials

2,027

Recruited

2,353,000+

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07397559

NCT07397559 | Spatiotemporal tSCS in Spinal Cord Injury

Although transcutaneous spinal cord stimulation has shown promising results in recovering lost movements, its poor selectivity in muscle recruitment compared to ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12560167/

Non-invasive spatiotemporal spinal neuromodulation ... - PMC

Recent studies showed the feasibility of using continuous transcutaneous spinal cord stimulation paired with gait training to improve gait ...

3.

iopscience.iop.org

iopscience.iop.org/article/10.1088/1741-2552/ac7b4b

Effects of transcutaneous spinal stimulation on ...

The findings from this study provide evidence of how TSS recruits cortical networks during tonic and rhythmic lower limb movements.

4.

sciencedirect.com

sciencedirect.com/science/article/pii/S1878875025001883

Hotspots and Trends in Spinal Cord Stimulation Research ...

This study employs bibliometric analysis to explore research trends and hotspots in SCS for motor recovery, highlighting advances and emerging directions over ...

5.

onlinelibrary.wiley.com

onlinelibrary.wiley.com/doi/full/10.1002/acn3.52281

Spatiotemporal spinal cord stimulation with real‐time ...

This case reveals the potential of SCS-EXS regimen in restoring walking capability of SCI patients.