Non-invasive Neuro-orthosis for Quadriplegia

Recruiting at 1 trial location

Overseen By David Friedenberg, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Ohio State University

Disqualifiers: Pacemaker, Seizure disorder, Cancer, others

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

Compensation: Varies

Number of Visits: 7

Duration: 12 weeks

12 Participants Needed

Trial Summary

What is the purpose of this trial?

The goal of this pilot clinical study is to investigate the NeuroLife EMG-FES Sleeve System, a closed-loop approach to functional electrical stimulation, in adults (n=12) with chronic (\>12 months) tetraplegia due to spinal cord injury. Briefly, the NeuroLife EMG-FES System is a completely non-invasive system (surface electrodes only, no implantable components) worn on the forearm which has up to 160 electrodes that can record electromyography (EMG), or muscle activity, and also electrically stimulate (FES) muscles. The main questions this study aims to answer are: 1) What is the safety, feasibility, and early efficacy of the NeuroLife EMG-FES system on upper extremity outcomes in chronic SCI survivors with tetraplegia, and 2) Can EMG be used as a biomarker of recovery over time in chronic SCI participants undergoing rehabilitation? Participants will complete an intensive, task-oriented rehabilitation protocol using the NeuroLife EMG-FES System (3x/week x 12 weeks) in an outpatient setting. We will assess functional outcomes using standardized clinical measures of hand and arm function at six timepoints.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you have a pacemaker or other implanted devices, you cannot participate in the trial.

What data supports the effectiveness of the NeuroLife EMG-FES Sleeve System treatment for quadriplegia?

Research on similar treatments, like functional electrical stimulation (FES) systems, shows they can help improve muscle function and mobility in people with spinal cord injuries. For example, FES has been used to assist walking in paraplegics and improve hand and arm function in those with upper spinal cord injuries, suggesting potential benefits for quadriplegia as well. ^{1 2 3 4 5}

Is the NeuroLife EMG-FES Sleeve System safe for use in humans?

Research on similar systems like NMES and FES shows they are generally safe for use in humans, even in those with heart devices, as long as individual risks are assessed beforehand. No adverse events were reported in studies involving long-term use of these systems. ^{6 7 8 9 10}

How is the NeuroLife EMG-FES Sleeve System treatment different from other treatments for quadriplegia?

The NeuroLife EMG-FES Sleeve System is unique because it is a non-invasive treatment that combines electromyography (EMG) and functional electrical stimulation (FES) to help restore muscle function in individuals with quadriplegia. Unlike invasive neuroprosthetic systems, this sleeve system does not require surgical implantation, making it a less risky and more accessible option for patients. ^{1 11 12 13 14}

Research Team

Lauren Wengerd, PhD

Principal Investigator

Ohio State University

David Friedenberg, PhD

Principal Investigator

Battelle Memorial Institute

Eligibility Criteria

This trial is for adults over 22 with chronic tetraplegia from a spinal cord injury, who can't grasp objects but can move their shoulders and elbows. They must be able to attend sessions in person and give informed consent. It's not for those with pacemakers, uncontrolled seizures or conditions that could affect safety or results.

Inclusion Criteria

I can move my shoulder and elbow on my own or with support.

I have had a spinal cord injury in my neck area for over a year.

Able to provide informed consent.

Exclusion Criteria

Comorbid medical condition that, in the opinion of the PI, may impact participant safety or study results

Pregnant or plan to become pregnant (females only)

You have severe and uncontrolled autonomic dysreflexia.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants complete an intensive, task-oriented rehabilitation protocol using the NeuroLife EMG-FES System

12 weeks

3 visits per week (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Assessments at baseline, 4 weeks, 8 weeks, post-intervention, and 4 weeks post-intervention

Treatment Details

Interventions

• NeuroLife EMG-FES Sleeve System

Trial Overview The NeuroLife EMG-FES Sleeve System is being tested on individuals with tetraplegia due to spinal cord injury. This non-invasive device uses electrodes to stimulate muscle activity in the forearm, aiming to restore hand function through rehabilitation therapy three times a week for twelve weeks.

Participant Groups

Group I: NeuroLife EMG-FES Sleeve System Experimental Treatment 1 Intervention

The NeuroLife EMG-FES System is a completely non-invasive system (surface electrodes only, no implantable components) worn on the forearm of participants and has up to 160 electrodes that can record electromyography (EMG), or muscle activity, and also electrically stimulate (FES) muscles. Using this combined, closed-loop technology participants will complete a 12-week protocol with a study therapist practicing functional activities using their hand/forearm while wearing the NeuroLife EMG-FES Sleeve System.

Who Is Running the Clinical Trial?

Ohio State University

Lead Sponsor

Trials

891

Recruited

2,659,000+

United States Department of Defense

Collaborator

Trials

940

Recruited

339,000+

Battelle Memorial Institute

Collaborator

Trials

14

Recruited

1,800+

Findings from Research

The Networked Neuroprosthesis (NNP) is the first fully implanted modular neuroprosthetic system that can electrically activate paralyzed muscles and record biopotential signals, offering a significant advancement in restoring functionality for individuals with spinal cord injuries.

Bench testing confirmed that the NNP can generate stimulus pulses and accurately record myoelectric, temperature, and accelerometer signals, indicating its potential for various clinical applications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Design and Testing of Stimulation and Myoelectric Recording Modules in an Implanted Distributed Neuroprosthetic System. Makowski, N., Campean, A., Lambrecht, J., et al.[2022]

Functional Electrical Stimulation (FES) has emerged as a promising treatment for paraplegics, aiming to restore muscle function, prevent atrophy, and improve mobility and quality of life, despite no current treatments being able to fully restore locomotion.

In a clinical application involving two paraplegic patients, an implanted FES neuroprosthesis demonstrated successful outcomes, with both patients reporting satisfaction after the procedure, highlighting the potential of this technology for enhancing rehabilitation in spinal cord injury cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Computer added locomotion by implanted electrical stimulation in paraplegic patients (SUAW). von Wild, K., Rabischong, P., Brunelli, G., et al.[2019]

The study presents a system that uses EMG pattern analysis to enable upper-motor-neuron paraplegics to control functional electrical stimulation (FES) for walking with a walker, demonstrating patient-responsive capabilities.

Since its experimental application began in 1982, the system has evolved to include below-lesion EMG control to adjust stimulation levels based on fatigue, enhancing its effectiveness for users.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

EMG pattern analysis for patient-responsive control of FES in paraplegics for walker-supported walking. Graupe, D.[2009]

A second-generation implantable neuroprosthesis was successfully tested in three individuals with C5/C6 spinal cord injuries, showing significant improvements in hand grasp and pinch force over a minimum of 2 years.

The system allowed users to control their hand functions through EMG signals, leading to enhanced performance in daily activities without any system failures, although two of the EMG electrodes required surgical revision.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An implanted upper-extremity neuroprosthesis using myoelectric control. Kilgore, KL., Hoyen, HA., Bryden, AM., et al.[2021]

The novel functional electrical stimulation (FES) system integrated into a powered exoskeleton significantly reduced the motor torques needed for users with paraplegia to perform sit-to-stand transitions, indicating improved efficiency in movement.

All three subjects with spinal cord injury experienced reduced muscle spasticity after using the exoskeleton with FES, and one subject showed enhanced joint movement and further reduced motor torques during over-ground walking, highlighting the potential benefits of FES in rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

FES Coupled With A Powered Exoskeleton For Cooperative Muscle Contribution In Persons With Paraplegia. Murray, SA., Farris, RJ., Golfarb, M., et al.[2020]

A pilot safety study involving six patients with implantable cardioverter defibrillators (ICDs) showed that long-term neuromuscular electrical stimulation (NMES) of thigh muscles is safe, with no adverse events reported during the treatment.

All patients received a total of over 14 million electrical pulses without any abnormalities in ICD function, suggesting that NMES can be a viable option for improving muscle strength and endurance in patients with chronic heart failure who have ICDs, provided individual risks are assessed beforehand.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term transcutaneous neuromuscular electrical stimulation in patients with bipolar sensing implantable cardioverter defibrillators: a pilot safety study. Crevenna, R., Wolzt, M., Fialka-Moser, V., et al.[2022]

The Nucleus 'FES-22' channel stimulation system was implanted in a 25-year-old paraplegic individual to help partially restore lower limb function, demonstrating its potential for improving mobility in similar patients.

Out of twenty electrodes attached to motor nerves, fifteen successfully produced muscle contractions, indicating effective stimulation and the system's capability to facilitate joint movements.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Initial results of the nucleus FES-22-implanted system for limb movement in paraplegia. Davis, R., MacFarland, WC., Emmons, SE.[2018]

Neuromuscular electrical stimulation (NMES) can effectively increase thigh muscle strength and endurance in heart failure patients, but its use must be carefully monitored due to potential electromagnetic interference (EMI) with implantable cardioverter-defibrillators (ICDs).

In a study of eight patients with ICDs, EMI was detected in three subjects during NMES, particularly when stimulating the neck and thighs, highlighting the need for individualized safety assessments for NMES in patients with ICDs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Electromagnetic interference by transcutaneous neuromuscular electrical stimulation in patients with bipolar sensing implantable cardioverter defibrillators: a pilot safety study. Crevenna, R., Stix, G., Pleiner, J., et al.[2022]

Functional Electrical Stimulation (FES) effectively restores controlled muscle contractions and limb function in patients with severe upper motor neuron lesions, particularly benefiting spinal cord injury patients.

To enhance patient acceptance and usability, future advancements in electrode technology and the development of 'close-loop' systems for better control and activation are necessary.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical applications of functional electrical stimulation. Kumar, VP., Lau, HK., Liu, J., et al.[2020]

Long-term use of functional electrical stimulation (FES) with percutaneous intramuscular wire electrodes has been shown to be effective and relatively safe for over 17 years in two participants with paraplegia, allowing them to stand and walk with assistance.

The study found that while localized inflammation and superficial infections were common, they were manageable with treatment, and improvements in electrode design significantly increased their survival rates, indicating a promising approach for rehabilitation in individuals with mobility impairments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Functional electrical stimulation for walking in paraplegia: 17-year follow-up of 2 cases. Agarwal, S., Kobetic, R., Nandurkar, S., et al.[2019]

A neuroprosthesis implant significantly improved walking speed, endurance, and overall gait performance in 21 patients with chronic foot drop due to central lesions, with notable improvements measured by various walking tests.

The procedure was safe, with only one case of postoperative bleeding (4%) and no need for surgical revisions, leading to high patient satisfaction (95%) and quality of life improvements (90%).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Foot drop treatment by implantation of a neuroprosthesis (ActiGait®)]. Yao, D., Jakubowitz, E., Ettinger, S., et al.[2018]

This study successfully demonstrated that an EEG-based brain-computer interface (BCI) can control a functional electrical stimulation (FES) system for overground walking in a person with paraplegia due to spinal cord injury, marking a significant step towards restoring voluntary movement.

The participant completed 30 walking tests over 19 weeks with high information transfer rates and no adverse events, suggesting that this noninvasive approach could lead to further research on brain-controlled walking solutions for individuals with spinal cord injuries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The feasibility of a brain-computer interface functional electrical stimulation system for the restoration of overground walking after paraplegia. King, CE., Wang, PT., McCrimmon, CM., et al.[2018]

The hybrid functional-electrical stimulation (FES) gait system, which includes a computer-controlled orthosis, significantly reduces muscle fatigue and improves movement control compared to traditional FES alone, as shown in a study with four subjects with paraplegia.

By using controllable friction brakes at the hip and knee joints, the system allows for better regulation of limb trajectories and provides necessary support during stance, although further hardware design improvements are needed for practical use outside the lab.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preliminary evaluation of a controlled-brake orthosis for FES-aided gait. Goldfarb, M., Korkowski, K., Harrold, B., et al.[2006]

Functional electrical stimulation (FES) of peripheral mixed nerves can effectively restore motor activity in patients with damaged upper motor neurons, as shown through various neurophysiological and clinical observations.

The therapeutic effects of FES are linked to mechanisms involving spinal reflexes and proprioceptive feedback, suggesting that this method can serve as a valuable orthotic aid for conditions like hemiplegia, paraparesis, and cerebral palsy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Functional electrical stimulation in control of motor output and movements. Gracanin, F.[2007]

References

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

Design and Testing of Stimulation and Myoelectric Recording Modules in an Implanted Distributed Neuroprosthetic System. [2022]

2. Austria pubmed.ncbi.nlm.nih.gov

Computer added locomotion by implanted electrical stimulation in paraplegic patients (SUAW). [2019]

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

EMG pattern analysis for patient-responsive control of FES in paraplegics for walker-supported walking. [2009]

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

An implanted upper-extremity neuroprosthesis using myoelectric control. [2021]

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

FES Coupled With A Powered Exoskeleton For Cooperative Muscle Contribution In Persons With Paraplegia. [2020]

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

Long-term transcutaneous neuromuscular electrical stimulation in patients with bipolar sensing implantable cardioverter defibrillators: a pilot safety study. [2022]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Initial results of the nucleus FES-22-implanted system for limb movement in paraplegia. [2018]

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

Electromagnetic interference by transcutaneous neuromuscular electrical stimulation in patients with bipolar sensing implantable cardioverter defibrillators: a pilot safety study. [2022]

9. Singapore pubmed.ncbi.nlm.nih.gov

Clinical applications of functional electrical stimulation. [2020]

10. England pubmed.ncbi.nlm.nih.gov

Functional electrical stimulation for walking in paraplegia: 17-year follow-up of 2 cases. [2019]

11. Germany pubmed.ncbi.nlm.nih.gov

[Foot drop treatment by implantation of a neuroprosthesis (ActiGait®)]. [2018]

12. England pubmed.ncbi.nlm.nih.gov

The feasibility of a brain-computer interface functional electrical stimulation system for the restoration of overground walking after paraplegia. [2018]

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

Preliminary evaluation of a controlled-brake orthosis for FES-aided gait. [2006]

14. Netherlands pubmed.ncbi.nlm.nih.gov

Functional electrical stimulation in control of motor output and movements. [2007]