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

4 Participants Needed

Trial Summary

What is the purpose of this trial?

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 function of their arms, legs, hands or feet. The study will involve therapy sessions involving exercises done at the same time as electrical stimulation therapy. This study has multiple parts to evaluate the effectiveness and safety of "smart" electrical stimulation of the spinal cord, which involves stimulating the spinal cord at precise locations and times to improve movement and function.

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 data supports the effectiveness of the treatment Occupational/Physical Therapy, RISES-T System for spinal cord injury?

Research shows that electrical stimulation can help improve muscle strength, endurance, and overall function in people with spinal cord injuries. It has been used to restore walking ability and improve other bodily functions, suggesting potential benefits for the RISES-T System in similar contexts. ^{1 2 3 4 5}

Is wearable electrical stimulation safe for humans with spinal cord injury?

Research on functional electrical stimulation (FES) for spinal cord injury, including devices like Parastep, has been conducted with human participants and has gone through FDA regulatory approval, indicating a level of safety for human use. ^{1 6 7 8 9}

How does the RISES-T System treatment differ from other treatments for spinal cord injury?

The RISES-T System is unique because it involves wearable electrical stimulation, which is a non-invasive method that can be used to enhance voluntary control of muscles in individuals with spinal cord injury. Unlike traditional methods, this system may offer a more flexible and adaptive approach to rehabilitation by using real-time, spatially selective stimulation to improve motor function. ^{1 3 4 7 10}

Research Team

Mijail D Serruya, MD, PhD

Principal Investigator

Thomas Jefferson University

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Clinical experience with functional electrical stimulation-assisted gait with Parastep in spinal cord-injured patients. [2019]

2. England pubmed.ncbi.nlm.nih.gov

Clinical applications of electrical stimulation after spinal cord injury. [2019]

3. England pubmed.ncbi.nlm.nih.gov

Targeted neurotechnology restores walking in humans with spinal cord injury. [2021]

4. England pubmed.ncbi.nlm.nih.gov

Spinal Cord Stimulation and Augmentative Control Strategies for Leg Movement after Spinal Paralysis in Humans. [2020]

5. United States pubmed.ncbi.nlm.nih.gov

Clinical evaluation of the bionic glove. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Estimating the user population of a simple electrical stimulation system for standing. [2018]

7. England pubmed.ncbi.nlm.nih.gov

A randomized trial of functional electrical stimulation for walking in incomplete spinal cord injury: Effects on walking competency. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Effect of alternating current stimulation of the spinal cord on recovery from acute spinal cord injury in rats. [2019]

9. United States pubmed.ncbi.nlm.nih.gov

An update on functional electrical stimulation after spinal cord injury. [2017]

10. United States pubmed.ncbi.nlm.nih.gov

Intraspinal microstimulation generates functional movements after spinal-cord injury. [2019]