Non-Invasive Neuromodulation for Spinal Cord Injury

(RISES-T2 Trial)

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Thomas Jefferson University

Disqualifiers: Cardiopulmonary disease, Mood disorders, Pregnancy, others

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

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine how neuromodulation, through electrical and magnetic stimulation, can improve movement in individuals with long-term spinal cord injuries. The researchers focus on identifying the optimal combination of these techniques to enhance mobility. Participants will use the RISES-T system, a non-invasive neuromodulation device, which provides stimulation during specific task practice. Ideal candidates have had a spinal cord injury for over a year and can participate in physical therapy. As an unphased trial, this study presents a unique opportunity to contribute to groundbreaking research that could enhance mobility for many.

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 the RISES-T System is safe for use in spinal cord injury patients?

Research has shown that the RISES-T System, which uses electrical signals on the spinal cord, has been tested for safety. Early studies found that this system is safe for people with spinal cord injuries. It works by sending small electrical signals to the spine to help improve movement.

In one study, researchers tested the safety of this technology and did not find any serious side effects. This suggests most people could use the system without major issues. Another study examined similar methods and found that they were generally well-tolerated, meaning people could use them without significant discomfort or harm.

Overall, the evidence so far suggests that the RISES-T System is safe for humans, with no major safety concerns reported in these studies. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Most treatments for spinal cord injury focus on rehabilitation exercises and medications that aim to manage symptoms and promote recovery. However, the RISES-T System is unique because it offers a non-invasive way to stimulate the spinal cord directly. This system uses closed-loop transcutaneous spinal cord stimulation, which means it can deliver electrical impulses through the skin to help improve motor functions while participants engage in repetitive task practice. Researchers are excited about this treatment because it could enhance the body's natural ability to heal and regain function without requiring surgery or long-term medication use.

What evidence suggests that the RISES-T System is effective for improving mobility in spinal cord injury?

Research has shown that the RISES-T System, which uses gentle electrical signals on the spine without surgery, may help people with spinal cord injuries. In one study, 72% of participants experienced significant improvements in arm movement. Another study found that combining electrical signals with physical exercises enhanced recovery in people with long-term spinal cord injuries, especially after several sessions. Some reports also mention improved bladder, bowel, and sexual function following spinal stimulation. While results can vary, these findings suggest potential benefits for movement and function in people with spinal cord injuries. Participants in this trial will receive closed-loop transcutaneous spinal cord stimulation via the RISES-T System while engaging in repetitive task practice. ^{1 2 3 5 6}

Are You a Good Fit for This Trial?

This trial is for individuals with chronic spinal cord injury or disease, at least a year post-injury, who can engage in therapy and have caregiver support. They must be able to consent and participate in recorded sessions. Those with severe medical conditions, uncontrolled symptoms, skin issues where electrodes attach, active implants like pacemakers, or are pregnant/breastfeeding cannot join.

Inclusion Criteria

My spinal injury is classified between A and D on the ASIA scale.

I can take part in physical and occupational therapy programs.

Is willing to undergo audio-visual recording sessions

Exclusion Criteria

Is not a candidate for other reason determined by the investigators

I do not have any severe health issues that could affect the study.

Has concurrent participation in another drug or device trial that may interfere with this study

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Part 1 - Assessment Sessions

Determine which muscles respond to stimulation and establish parameters for Part 2

4 weeks

Multiple visits for baseline assessments and parameter setting

Part 2 - Experimental Cycles

Intervention sessions with transcutaneous stimulation and biometric assessments

Up to 22 weeks

Regular visits for intervention and assessment

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• RISES-T System

Trial Overview The RISES-T System is being tested to see how non-invasive electrical and magnetic neuromodulation techniques affect mobility in people with chronic spinal injuries. The study aims to find the best combination of these techniques to improve movement.

How Is the Trial Designed?

Group I: Experimental Treatment Arm Experimental Treatment 1 Intervention

Participants will receive closed-loop transcutaneous spinal cord stimulation via the RISES-T System while completing repetitive task practice

Who Is Running the Clinical Trial?

Thomas Jefferson University

Lead Sponsor

Trials

475

Recruited

189,000+

Tim Reynolds

Collaborator

Trials

1

Recruited

10+

Published Research Related to This Trial

A novel noninvasive stimulation strategy combined with pharmacological intervention successfully re-engaged spinal locomotor networks in individuals with motor complete paralysis, enabling locomotor-like stepping without voluntary effort during a single session.

After 18 weeks of treatment, all five subjects showed significant improvements in voluntary motor control, with evidence of re-established functional connectivity between the brain and spinal cord, allowing for selective muscle activation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Noninvasive Reactivation of Motor Descending Control after Paralysis. Gerasimenko, YP., Lu, DC., Modaber, M., et al.[2018]

Electrochemical neuromodulation therapies and robot-assisted rehabilitation have shown promise in restoring voluntary leg movements in chronic paraplegic individuals, indicating potential for improving mobility after spinal cord injuries.

In rodent models, these therapies led to significant remodeling of neural pathways, suggesting that similar mechanisms may be effective in humans, although challenges remain in translating these findings into widespread clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neuroprosthetic technologies to augment the impact of neurorehabilitation after spinal cord injury. van den Brand, R., Mignardot, JB., von Zitzewitz, J., et al.[2018]

Transdermal micropolarization using local direct currents improved motor and autonomic functions in patients with spinal cord trauma and tuberculous spondylitis, indicating its potential as a therapeutic intervention.

The study monitored clinical and electrophysiological changes, suggesting that direct currents can positively affect the functional state of the spinal cord and heart activity, highlighting the mechanism of action for this treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The use of micropolarization in the treatment of spinal cord lesions. Shelyakin, AM., Preobrazhenskaya, IG., Komantsev, VN., et al.[2019]

In a study involving 122 participants with chronic low back and/or leg pain, multiphase spinal cord stimulation (SCS) significantly reduced pain levels, with mean reductions of -4.3 and -4.7 on the numerical rating scale for two different multiphase therapies.

The multiphase SCS therapies were found to be safe, with only one non-serious device-related adverse event reported and no infections, suggesting a favorable safety profile for this new stimulation paradigm.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multiphase Spinal Cord Stimulation in Participants With Chronic Back or Leg Pain: Results of the BENEFIT-02 Randomized Clinical Trial. Kapural, L., Patterson, DG., Li, S., et al.[2023]

Spinal cord stimulation (SCS) is evolving from a treatment for intractable pain to a potential method for restoring function after spinal cord injuries, driven by advances in understanding spinal cord lesions and compensatory mechanisms.

New SCS strategies, like spatiotemporal neuromodulation, show promise but require intensive rehabilitation techniques to be effective, highlighting the need for well-designed clinical trials to evaluate safety and efficacy in real-world applications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Advances in Spinal Cord Neuromodulation: The Integration of Neuroengineering, Computational Approaches, and Innovative Conceptual Frameworks. Pradat, PF., Hayon, D., Blancho, S., et al.[2023]

In a proof-of-concept study involving three adults with cervical spinal cord injury, repetitive QuadroPulse transcranial magnetic stimulation (rTMS(QP)) showed functional benefits, particularly in improving walking speed and cortical excitability without any adverse effects.

The combination of rTMS(QP) with targeted exercises led to even greater improvements in motor function, suggesting that this approach could be effective and warrants further investigation in larger studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of QuadroPulse rTMS for improving motor function after spinal cord injury: Three case studies. Alexeeva, N., Calancie, B.[2018]

Transcutaneous electrical stimulation of the spinal cord (TESS) significantly enhances motor-evoked potentials in arm muscles for up to 75 minutes after stimulation, indicating its potential to promote functional recovery in individuals with spinal cord injury (SCI).

The study found that TESS has a dual effect: it excites spinal networks while inhibiting cortical activity, which may contribute to improved hand and arm function, especially when using a specific 5 kHz carrier frequency during stimulation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cortical and Subcortical Effects of Transcutaneous Spinal Cord Stimulation in Humans with Tetraplegia. Benavides, FD., Jo, HJ., Lundell, H., et al.[2021]

A new animal model for transcutaneous spinal cord stimulation (tSCS) was developed, which accurately mimics human responses and allows for stable, repeated treatments after spinal cord injury (SCI) with minimal restraint.

The study demonstrated that tSCS can effectively modulate motor output in rats after complete spinal cord transection, suggesting its potential for promoting neuroplasticity and functional recovery in SCI.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adapting Human-Based Transcutaneous Spinal Cord Stimulation to Develop a Clinically Relevant Animal Model. Malloy, DC., Knikou, M., Côté, MP.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11483808/

Initial feasibility evaluation of the RISES system: An innovative ... Anecdotal reports of stimulation with spinal cord injury show mixed results with some patients reporting benefits and others not. The small ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05669508

Wearable Electrical Stimulation on the Back to Modulate ... The goal of this study is to evaluate if non-invasive electrical spinal stimulation can help people with paralysis caused by SCI improve strength and ...

3. 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 ...

4. 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) ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9668071/

Spinal electrical stimulation to improve sympathetic autonomic ... Improvements in bladder, bowel and sexual outcomes following task-specific locomotor training in human spinal cord injury. PLoS One 13: e0190998, 2018. doi ...

6. neurorestoration.jefferson.edu neurorestoration.jefferson.edu/programs-clinical-trials/rises-program.html

Reynolds Innovative Spinal Electrical Stimulation (RISES ... The goal of this study is to evaluate if non-invasive electrical spinal stimulation can help people with paralysis caused by spinal cord injury.