Neuroprosthesis for Spinal Cord Injury

(Trunk Protocol Trial)

Overseen By Emily C Johnson, BA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Disqualifiers: Pregnancy, Non-English speaking, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

10 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to evaluate a surgically implanted functional electrical stimulation (FES) system to facilitate stability of the trunk and hips. FES involves applying small electric currents to the nerves, which cause the muscles to contract. This study evaluates how stabilizing and stiffening the trunk with FES can change the way spinal cord injured volunteers sit, breathe, reach, push a wheelchair, or roll in bed.

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 data supports the effectiveness of the treatment IRS-8, Implanted Stimulator for Walking After Stroke, IRS-8?

Research shows that similar implanted neuroprosthesis systems have helped people with spinal cord injuries regain voluntary control of their muscles and improve their ability to walk. These systems use electrical stimulation to activate muscles, and studies have demonstrated improvements in walking and standing abilities, as well as overall health benefits. ^{1 2 3 4 5}

Is the neuroprosthesis for spinal cord injury safe for humans?

The neuroprosthesis for spinal cord injury has been reported as safe and reliable in humans, with no incidents of deep-vein thrombosis, infection, cellulitis, or electrical burns. Users have noted improved health and reduced pressure sores, leg spasms, and urinary tract infections, and they expressed satisfaction with the device. ^{3 5 6 7 8}

How does the IRS-8 treatment for spinal cord injury differ from other treatments?

The IRS-8 treatment is unique because it uses intraspinal microstimulation (ISMS) to activate remaining motor-control networks in the spinal cord, potentially restoring walking with fewer electrodes and more natural movement patterns compared to other electrical stimulation methods. ^{1 3 9 10 11}

Research Team

Ronald Triolo, PhD

Principal Investigator

Louis Stokes VA Medical Center, Cleveland, OH

Eligibility Criteria

This trial is for English-speaking adults with spinal cord injuries (quadriplegia or paraplegia) between C4-T12, ASIA Scale A-C. They should be stable post-injury (>6 months), without severe bone density issues, orthopedic problems, medical complications, psychological issues, or substance abuse. Participants need normal range of motion and body size and must not be pregnant.

Inclusion Criteria

My muscle stiffness is under control and I don't have spasms that pull my hip up or inward.

My spinal injury is between the C4 and T12 vertebrae.

Your injury happened more than 6 months ago.

Exclusion Criteria

Non-English speaking

Pregnancy

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgical Procedure

Electrodes are surgically implanted into muscles of the trunk and hip musculature

1 week

1 visit (in-person)

Post-operative Recovery

Participants undergo a period of restricted activity to promote healing of surgical incisions

2-6 weeks

Training and Exercise

Participants engage in exercise and training to begin functional use of the neuroprosthesis

4-8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, including laboratory assessments of strength, balance, and functional abilities

up to 36 months

Treatment Details

Interventions

• IRS-8

Trial Overview The study tests an implanted device called IRS-8 that uses electrical currents to help stabilize the trunk and hips in people with spinal cord injuries. It aims to improve their ability to sit up straight, breathe easier, reach out, push a wheelchair more effectively, and roll over in bed.

Participant Groups

Group I: Neuroprosthesis Experimental Treatment 1 Intervention

Volunteers are evaluated for appropriateness for inclusion in the study on an intent-to-treat basis. Qualifying candidates all receive the implanted neuroprosthesis and participate in post-operative training and follow-up procedures.

IRS-8 is already approved in United States for the following indications:

Approved in United States as IRS-8 for:

• Improving walking in stroke survivors

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Findings from Research

The study involved 15 participants with spinal cord injuries who used an 8-channel neuroprosthesis for lower-extremity exercise and standing, showing consistent usage and integration into daily life over a year.

The neuroprosthesis demonstrated high safety and reliability, with over 90% component survivability and stable electrode performance, suggesting it could be a viable option for future commercialization.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Longitudinal performance of a surgically implanted neuroprosthesis for lower-extremity exercise, standing, and transfers after spinal cord injury. Triolo, RJ., Bailey, SN., Miller, ME., et al.[2021]

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 study introduces a wireless stimulator device designed for intraspinal stimulation (ISMS), which aims to activate residual motor-control networks in the spinal cord to restore walking in individuals with spinal cord injuries.

Acute animal experiments have shown that ISMS can effectively produce coordinated walking patterns, and this wireless system is intended for chronic studies, paving the way for potential human applications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An implantable neural stimulator for intraspinal microstimulation. Troyk, PR., Mushahwar, VK., Stein, RB., et al.[2021]

An implanted neuroprosthesis significantly improved walking distance for a female participant with C6 AIS C spinal cord injury, increasing her walking distance from 95 meters to 488 meters, while also enhancing her walking speed over longer distances.

The use of electrical stimulation not only improved joint movements (like hip and knee flexion) but also reduced oxygen consumption and upper extremity forces, indicating a more efficient walking pattern with the device.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of an implanted neuroprosthesis on community ambulation in incomplete SCI. Lombardo, LM., Kobetic, R., Pinault, G., et al.[2019]

The surgically implanted neuroprosthesis allowed 12 volunteers with longstanding paralysis to stand, transfer, and manipulate objects, demonstrating significant functional improvements after rehabilitation.

The system showed reliable performance with a 90% survival rate of implanted electrodes over 4 years, and users experienced health benefits such as reduced risk of pressure sores and improved spasticity management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preliminary performance of a surgically implanted neuroprosthesis for standing and transfers--where do we stand? Davis, JA., Triolo, RJ., Uhlir, J., et al.[2006]

In a study of 11 individuals with spinal cord injuries who had received a surgically implanted neuroprosthesis, all participants reported significant health improvements, including fewer pressure sores, leg spasms, and urinary tract infections, indicating the device's efficacy in enhancing health outcomes.

The neuroprosthesis was deemed safe and reliable, with no serious complications reported, and recipients expressed high satisfaction with its performance, showing a strong willingness to undergo the procedure again for similar benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term user perceptions of an implanted neuroprosthesis for exercise, standing, and transfers after spinal cord injury. Agarwal, S., Triolo, RJ., Kobetic, R., et al.[2015]

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]

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]

An intracortical neuroprosthetic intervention targeting the motor cortex significantly improved locomotion in rats with incomplete spinal cord injury, alleviating issues like leg dragging and enhancing control of leg movements.

Long-term neuroprosthetic training led to lasting improvements in cortical control of locomotion, suggesting that directly stimulating the motor cortex could be a promising approach for rehabilitation after spinal cord injuries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An intracortical neuroprosthesis immediately alleviates walking deficits and improves recovery of leg control after spinal cord injury. Bonizzato, M., Martinez, M.[2021]

A new fully implantable epidural spinal cord stimulation (ESCS) system has been developed for use in rats, allowing researchers to study the neural mechanisms of recovery after spinal cord injury (SCI) in a more practical and efficient way.

This innovative system is programmable and batteryless, enabling chronic experiments without the need for tethering, which could lead to better understanding and advancements in treatments for functional recovery in individuals with SCI.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Fully Implantable Stimulator With Wireless Power and Data Transmission for Experimental Investigation of Epidural Spinal Cord Stimulation. Xu, Q., Hu, D., Duan, B., et al.[2015]

A new wireless telemetry system has been developed to enhance the control of functional electrical stimulation (FES) for walking in spinal cord injury (SCI) patients, allowing for reliable and interference-resistant operation.

This system enables patients to control their gait phases using crutches, improving their ability to stand and walk, and is currently being utilized in rehabilitation settings for both complete and incomplete SCI cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Voluntary telemetry control of functional electrical stimulators. Matjacić, Z., Munih, M., Bajd, T., et al.[2019]

References

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

Longitudinal performance of a surgically implanted neuroprosthesis for lower-extremity exercise, standing, and transfers after spinal cord injury. [2021]

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

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

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

An implantable neural stimulator for intraspinal microstimulation. [2021]

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

Impact of an implanted neuroprosthesis on community ambulation in incomplete SCI. [2019]

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

Preliminary performance of a surgically implanted neuroprosthesis for standing and transfers--where do we stand? [2006]

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

Long-term user perceptions of an implanted neuroprosthesis for exercise, standing, and transfers after spinal cord injury. [2015]

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

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

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

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

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

An intracortical neuroprosthesis immediately alleviates walking deficits and improves recovery of leg control after spinal cord injury. [2021]

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

A Fully Implantable Stimulator With Wireless Power and Data Transmission for Experimental Investigation of Epidural Spinal Cord Stimulation. [2015]

11. England pubmed.ncbi.nlm.nih.gov

Voluntary telemetry control of functional electrical stimulators. [2019]