Spinal Stimulation for Spinal Cord Injury

Overseen By Alison Gorbatov

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Disqualifiers: Epilepsy, Intracranial metal, Pregnancy, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 5 years

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a treatment called transcutaneous spinal stimulation, which uses electrical signals to assist people with chronic spinal cord injuries. The goal is to determine if this approach can improve movement and quality of life for Veterans who have lost feeling and movement below their injury. Researchers aim to identify which patients will benefit most from this treatment. Individuals who have had a spinal cord injury for more than a year and can follow simple English instructions might be suitable for this study. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could enhance future treatment options.

Will I have to stop taking my current medications?

The trial information does not specify whether 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 technique is safe for Veterans with spinal cord injury?

Research shows that transcutaneous spinal stimulation (TSS), a method used to assist people with spinal cord injuries, appears to be safe. One study tested it on seven people with spinal cord injuries and found it safe and feasible. Another study found that many participants achieved their treatment goals during therapy sessions. These studies suggest that participants generally tolerate TSS well. However, more research with larger groups is needed to fully understand its safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Transcutaneous Spinal Stimulation is unique because it offers a non-invasive alternative to traditional treatments for spinal cord injury, such as surgery or more invasive electrical stimulation options. Unlike these standard treatments, which often involve complex procedures and significant recovery time, Transcutaneous Spinal Stimulation uses external electrical currents to activate nerve circuits in the spine, potentially enhancing movement and function without the need for surgery. Researchers are excited about this approach because it could provide a safer, more accessible way to improve mobility and quality of life for patients with spinal cord injuries.

What evidence suggests that transcutaneous spinal stimulation might be an effective treatment for spinal cord injury?

Research has shown that transcutaneous spinal stimulation, which uses electrical currents on the skin to stimulate the spinal cord, can aid people with spinal cord injuries (SCI) in improving movement. Studies have found that this treatment enhances leg movement, balance, trunk control, and the ability to stand. Specifically, one study reported that 72% of participants improved their hand and arm function after undergoing this therapy. When combined with activity-based training, the treatment has been linked to significant recovery, particularly after several sessions. These findings suggest that this approach may help people with long-term SCI regain some voluntary movement and independence.

In this single-arm trial, all participants will undergo the same neurophysiological, imaging, and functional testing to evaluate the effects of transcutaneous spinal stimulation. ^{2 3 4 6 7}

Who Is on the Research Team?

Jonathan Calvert, MD

Principal Investigator

Providence VA Medical Center, Providence, RI

Are You a Good Fit for This Trial?

This trial is for Veterans with chronic spinal cord injury (SCI) who are seeking new rehabilitation methods. The study aims to understand the remaining neural connections in these individuals and assess improvements through non-invasive neuromodulation technology.

Inclusion Criteria

Participants must be able to independently read and understand study information materials necessary to ensure informed consent

Ability to follow simple commands in English

My spinal cord injury occurred over a year ago.

Exclusion Criteria

Pregnancy

Contraindications to the use of external magnetic or electrical stimulation (e.g., epilepsy, intracranial metal, implanted electrosensitive device, etc.)

Significant neurological comorbidities that may affect neurophysiological recordings

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Baseline anatomical and physiological connectivity measurements across ISNCSCI scores will be established.

8 weeks

Multiple visits for neuroimaging and connectivity assessments

Treatment

Participants undergo non-invasive spinal neuromodulation to assess functional spinal connectivity and potential improvements.

5 years

Regular visits for neuromodulation and functional assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Periodic follow-up visits

What Are the Treatments Tested in This Trial?

Interventions

• Transcutaneous Spinal Stimulation

Trial Overview

The trial is testing a novel approach that includes neurophysiological and anatomical testing, along with Transcutaneous Spinal Stimulation, to potentially restore voluntary motor function and improve quality of life in Veterans with SCI.

How Is the Trial Designed?

Group I: Single-arm Experimental Treatment 2 Interventions

This is a single-arm study where all participants will undergo the same neurophysiological, imaging, and functional testing.

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12548825/

Effectiveness of Transcutaneous Spinal Cord Stimulation for ...

The primary outcome will be lower limb motor function assessed by validated measures such as the Lower Extremity Motor Score. Secondary outcomes ...

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.

frontiersin.org

frontiersin.org/journals/rehabilitation-sciences/articles/10.3389/fresc.2021.740307/full

Transcutaneous Electrical Spinal Cord Stimulation to ...

Enhanced trunk control and stability (9), improved lower extremity (LE) function, locomotor output, and standing (6, 8, 13) as well as reduced ...

4.

nature.com

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

Non-invasive spinal cord electrical stimulation for arm and ...

These results demonstrate the safety and efficacy of ARC EX Therapy to improve hand and arm functions in people living with cervical SCI.

5.

neurology.org

neurology.org/doi/10.1212/WNL.0000000000205724

Transcutaneous Spinal Cord Stimulation (ARC-EX Therapy ...

Of sixty participants who completed the in-clinic ARCEX Therapy phase, 72% met the predefined primary effectiveness endpoint. CUE-T scores and pinch forces ...

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.

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 ...