Spinal Stimulation and Exercise for Spinal Cord Injury

Overseen By Chet Moritz, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Washington

Must not be taking: Anticoagulants, Osteoporosis medications

Disqualifiers: Autoimmune, Neurologic, Cancer, Cardiovascular, others

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

Compensation: Varies

Number of Visits: 4

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether combining spinal cord stimulation with physical therapy can improve walking and movement in people with certain spinal cord injuries. Researchers are examining both immediate and long-term benefits of this treatment. The study targets individuals who have had a spinal cord injury for at least a year and struggle with daily activities like walking and standing. Participants will experience different treatment phases, alternating between physical therapy alone and physical therapy with electrical stimulation (transcutaneous spinal stimulation). The goal is to determine if adding stimulation significantly improves mobility. As an unphased trial, this study allows participants to contribute to groundbreaking research that could enhance rehabilitation options for spinal cord injuries.

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

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this spinal stimulation and exercise protocol is safe for spinal cord injury patients?

Research has shown that transcutaneous spinal stimulation, a non-invasive treatment using electrical currents on the skin, is generally safe for people with spinal cord injuries. Studies have found that it can improve movement, particularly in walking and standing. Participants in past research handled the treatment well, with no serious side effects reported, suggesting it is safe when combined with physical therapy.

The research also indicates that this method is painless and well-tolerated. It has improved both short-term and long-term movement abilities. Therefore, for those considering joining a trial with transcutaneous spinal stimulation, the evidence suggests it is a safe option for enhancing mobility. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about transcutaneous spinal stimulation combined with physical therapy for spinal cord injury because it offers a new approach to rehabilitation. Unlike traditional physical therapy alone, this method uses electrical stimulation to target the spinal cord non-invasively, potentially enhancing the recovery of walking and standing functions. This combination could lead to more effective and faster improvements in mobility compared to standard care options, giving hope for better quality of life for those with spinal cord injuries.

What evidence suggests that transcutaneous spinal stimulation and physical therapy could be effective for spinal cord injury?

Research has shown that using electrical pulses on the skin to stimulate the spinal cord, known as transcutaneous spinal stimulation, can greatly improve movement and walking in people with spinal cord injuries. In this trial, one group of participants will receive transcutaneous spinal stimulation combined with physical therapy, which studies have shown enhances recovery, especially with repeated sessions. In one study, 72% of participants experienced significant improvements in arm and hand strength using this method. This treatment is also considered safe and well-tolerated. Another group in this trial will receive physical therapy only, targeting the rehabilitation of walking and standing functions. Overall, evidence suggests that combining transcutaneous spinal stimulation with physical therapy improves both immediate and long-term movement abilities. ^{2 3 6 7 8}

Are You a Good Fit for This Trial?

This trial is for adults aged 21-70 with spinal cord injuries at T12 or higher, lasting over a year. Participants should be able to perform simple tasks and have mobility issues but must not have severe medical conditions like heart disease or uncontrolled high blood pressure. They need to commit up to five times weekly for therapy sessions and assessments in English, without significant depression or anxiety.

Inclusion Criteria

I am between 21 and 70 years old.

My doctor has approved me for walking training.

I have had a spinal cord injury above my waist for over a year.

Exclusion Criteria

I do not have uncontrolled high blood pressure or serious heart, lung, or blood clotting issues.

I have a condition that could affect my ability to participate in leg exercises or tests.

I understand the instructions given in the study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Physical Therapy

Participants undergo one month of physical therapy targeting rehabilitation of walking and standing functions

4 weeks

2-5 visits per week

Spinal Stimulation with Physical Therapy

Participants receive spinal stimulation combined with physical therapy for one month

4 weeks

2-5 visits per week

Washout Period

A washout period of up to one month to determine any after-effects of the interventions

up to 4 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

8-11 months

What Are the Treatments Tested in This Trial?

Interventions

• Physical Therapy
• Transcutaneous Spinal Stimulation

Trial Overview The study tests the effectiveness of non-invasive electrical stimulation on the neck and lower back combined with intensive physical therapy to improve movement in people with incomplete tetraplegia and paraplegia. It involves phases of just physical therapy followed by both therapies together, assessing immediate and long-term improvements.

How Is the Trial Designed?

Group I: Transcutaneous spinal stimulation & Physical therapy Active Control 2 Interventions

Transcutaneous electrical stimulation combined with physical therapy that targets rehabilitation of walking and standing functions

Group II: Physical therapy only Active Control 1 Intervention

Physical therapy that targets rehabilitation of walking and standing functions

Who Is Running the Clinical Trial?

University of Washington

Lead Sponsor

Trials

1,858

Recruited

2,023,000+

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. clinicaltrials.gov clinicaltrials.gov/study/NCT06587841

Noninvasive Spinal Cord Stimulation for Early SCI The purpose of this clinical study is to investigate the safety and effectiveness of non-surgical transcutaneous spinal cord stimulation (TSCS) in helping with ...

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

Non-invasive spinal cord electrical stimulation for arm and ... ARCEX Therapy was found to be safe and effective in 72% of participants to mediate improvements of strength and function in the hands and arms ...

5. jneuroengrehab.biomedcentral.com jneuroengrehab.biomedcentral.com/articles/10.1186/s12984-025-01557-4

Non-invasive cerebral and spinal cord stimulation for motor ... In this review we aim to compare the effect of non-invasive cerebral and spinal cord stimulation on gait recovery and motor strength of lower limbs in subjects ...

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 ...

7. hopkinsmedicine.org hopkinsmedicine.org/clinical-trials/results/irb00300695

Transcutaneous spinal stimulation (TSS) in children with ... Administration of TSCS to children in a clinical setting will be safe based on similar safety outcomes as sham TSCS.

8. clinicaltrials.gov clinicaltrials.gov/study/NCT03975634

Transcutaneous Spinal Stimulation: Safety and Feasibility ... Activity-based locomotor training has resulted in improved trunk control in children with spinal cord injury, though full recovery is not achieved in all ...