Wearable Electrical Stimulation for Spinal Cord Injury

(RISES-T Trial)

Overseen By Erica Jones, BA

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Thomas Jefferson University

Disqualifiers: Cardiopulmonary disease, Neuropathic pain, Depression, 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 tests whether a wearable device using electrical stimulation, known as the RISES-T System, can help individuals with paralysis from a spinal cord injury (SCI) improve strength and movement in their arms, legs, hands, or feet. Participants will engage in exercise sessions while receiving targeted electrical signals to specific parts of the spinal cord. The trial seeks individuals who have had a non-progressive spinal cord injury for at least a year, possess some movement ability, and can participate in physical and occupational therapy. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could enhance rehabilitation options for SCI patients.

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 study team to get a clear answer.

What prior data suggests that the RISES-T System is safe for spinal cord injury patients?

Research has shown that the RISES-T System, which uses electrical signals to assist people with spinal cord injuries, has undergone safety testing. Studies found no major harmful effects. The main safety checks focused on skin health, vital signs like heart rate and blood pressure, pain, and fatigue. These studies demonstrated that skin remained healthy, and there were no significant changes in vital signs. Pain and fatigue were monitored closely, with no concerning patterns identified. The system uses a method that adjusts stimulation based on real-time movement, potentially enhancing safety and effectiveness. This technology has been tested multiple times, and participants have tolerated it well so far. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for spinal cord injury, which often focus on rehabilitation exercises and medications to manage symptoms, the RISES-T System uses a unique approach by delivering closed-loop transcutaneous spinal cord stimulation. This technique involves applying electrical stimulation through the skin to the spinal cord, which could potentially enhance functional recovery by directly targeting the injured area. Researchers are excited about this treatment because it integrates stimulation with occupational therapy sessions, potentially leading to improved outcomes in motor function and independence for patients. This innovative method offers a new avenue for spinal cord injury treatment, aiming to directly influence the nervous system's ability to repair and adapt.

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

Research has shown that non-invasive electrical spinal stimulation, such as the RISES-T System, may enhance strength and movement in individuals with spinal cord injuries. In this trial, participants will receive closed-loop transcutaneous spinal cord stimulation through the RISES-T System while engaging in functional task practice during occupational therapy sessions. Studies suggest that combining this therapy with specific exercises can improve muscle control and function. The RISES-T System employs a closed-loop method, adjusting stimulation based on movement feedback, which may increase its effectiveness. Some patients demonstrated significant improvements after multiple sessions, particularly when stimulation targeted the correct spinal areas. However, results can vary, and not everyone experiences the same level of benefit. ^{1 4 5 6 7}

Who Is on the Research Team?

Mijail D Serruya, MD, PhD

Principal Investigator

Thomas Jefferson University

Are You a Good Fit for This Trial?

This trial is for individuals with non-progressive spinal cord injuries from C2-T10, at least one year post-injury, and classified as B, C, or D on the ASIA scale. Participants must be able to consent and engage in physical therapy with caregiver support. It's not suitable for those with severe cardiopulmonary disease, unexcitable muscles due to lower motor neuron injury, severe neuropathic pain or cognitive disorders, skin breakdown where electrodes are placed, active implanted devices or pregnancy.

Inclusion Criteria

It has been at least a year since my spinal cord injury.

I am able to join in physical and occupational therapy programs.

Has adequate caregiver support to facilitate participation in study

Exclusion Criteria

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

My spasms prevent me from joining in study activities.

I have heart or lung conditions that are not well-managed.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants complete a baseline assessment of outcome measures and undergo mapping with sensors to characterize their motor signature

1-2 weeks

Open-loop SCS Phase

Participants undergo 15 open-loop transcutaneous spinal cord stimulation sessions combined with functional task practice

6 weeks

Closed-loop SCS Phase

Participants undergo 15 closed-loop transcutaneous spinal cord stimulation sessions combined with functional task practice

6 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Occupational/Physical Therapy
• RISES-T System

Trial Overview The RISES-T System is being tested alongside occupational/physical therapy to see if 'smart' electrical stimulation can improve movement in people paralyzed by spinal cord injuries. The study involves exercises paired with targeted spinal stimulation to potentially enhance arm and leg function.

How Is the Trial Designed?

Group I: Treatment Arm Experimental Treatment 2 Interventions

Participants will receive closed-loop transcutaneous spinal cord stimulation via the RISES-T System while completing functional task practice in occupational therapy sessions.

Who Is Running the Clinical Trial?

Thomas Jefferson University

Lead Sponsor

Trials

475

Recruited

189,000+

Kessler Foundation

Collaborator

Trials

190

Recruited

11,300+

Published Research Related to This Trial

A 16-week program of FES-assisted walking significantly improved mobility in individuals with chronic incomplete spinal cord injury compared to a non-FES exercise program, as shown by the increase in the SCIM mobility sub-score.

Both groups showed improvements in walking speed, endurance, and balance, indicating that task-oriented training is beneficial for enhancing walking ability, even in chronic stages of spinal cord injury.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized trial of functional electrical stimulation for walking in incomplete spinal cord injury: Effects on walking competency. Kapadia, N., Masani, K., Catharine Craven, B., et al.[2021]

Epidural spinal cord stimulation can activate spared neural circuitry below severe spinal cord injuries, enabling paralyzed individuals to achieve motor outputs like standing and stepping during assisted treadmill exercises.

This stimulation not only generates immediate motor responses but also supports rehabilitation by promoting long-term neural plasticity, potentially leading to lasting improvements in motor function for patients with spinal cord injuries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Spinal Cord Stimulation and Augmentative Control Strategies for Leg Movement after Spinal Paralysis in Humans. Minassian, K., Hofstoetter, US.[2020]

Targeted spinal cord stimulation allowed individuals with spinal cord injuries, who had been paralyzed for over four years, to regain voluntary control of their leg movements within a week of treatment.

Participants showed significant improvements in walking ability and could perform activities like walking or cycling in real-world settings after months of rehabilitation, demonstrating the potential of this technology for enhancing recovery and daily living post-injury.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Targeted neurotechnology restores walking in humans with spinal cord injury. Wagner, FB., Mignardot, JB., Le Goff-Mignardot, CG., et al.[2021]

The Parastep method, a functional electrical stimulation device, enabled 13 out of 15 spinal cord-injured patients to achieve independent ambulation with a walker after an average of 20 training sessions, demonstrating its potential for improving mobility.

Despite its benefits, the Parastep method has limited applications for daily mobility due to high energy costs and cardiovascular strain, although it can still provide significant psychological and physical fitness benefits for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical experience with functional electrical stimulation-assisted gait with Parastep in spinal cord-injured patients. Brissot, R., Gallien, P., Le Bot, MP., et al.[2019]

Intraspinal microstimulation (ISMS) effectively restored locomotion in four adult male cats with complete spinal-cord transection, demonstrating bilateral weight-bearing stepping with good foot clearance during movement.

The technique showed minimal fatigue and maintained consistent kinematics over 40 consecutive steps, suggesting that ISMS could be a viable method for improving mobility after spinal cord injuries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intraspinal microstimulation generates functional movements after spinal-cord injury. Saigal, R., Renzi, C., Mushahwar, VK.[2019]

Citations

1. 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 ...

2. 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 ...

3. mdpi.com mdpi.com/2306-5354/12/4/410

Optimizing Transcutaneous Spinal Cord Stimulation The closed-loop mode can adjust stimulation parameters dynamically based on real-time movement data, allowing for enhanced responsiveness during therapy. A ...

4. withpower.com withpower.com/trial/phase-spinal-cord-injuries-1-2022-d2782

Wearable Electrical Stimulation for Spinal Cord Injury · Info ... 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 ...

5. 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 ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39421013/

An innovative and activity-based closed-loop framework for ... Primary safety outcome measures included adverse events (AEs) and skin integrity; secondary measures were vital signs, pain, and fatigue ...

7. researchgate.net researchgate.net/publication/372634681_The_RISES_System_An_Innovative_and_Activity-Based_Closed-Loop_Platform_for_Spinal_Cord_Injury_Rehabilitation_and_Recovery

An Innovative and Activity-Based Closed-Loop Platform for ... The trial included open-loop and closed-loop blocks of transcutaneous spinal cord stimulation (tSCS). Results Results showed no serious adverse ...