Neuroprosthetic System for Spinal Cord Injury

(NNP-UE+T Trial)

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Kevin Kilgore

Disqualifiers: Pregnancy, Neurological conditions, Cardiopulmonary disease, 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: Unknown

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new implantable device designed to help individuals with cervical spinal cord injuries regain hand, arm, and trunk movement. The goal is to determine if this neuroprosthetic system, known as the Networked Neuroprosthetic System for Grasp and Trunk, can improve daily functions like reaching and grasping. It suits individuals who have had a cervical spinal cord injury for at least six months and retain some muscle strength in their arms and trunk. Participants will receive the implant and undergo training to enhance their functional abilities. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research and potentially benefit from innovative technology.

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 conditions like severe cardiopulmonary disease or are on medications that interact with implantable devices, you might need to discuss this with the trial team.

What prior data suggests that this device is safe for individuals with cervical spinal cord injury?

Research has shown that neuroprosthetic devices have been safely used in people with spinal cord injuries for over 30 years. These devices are implanted to help restore functions like moving arms and hands. Past studies found that most patients tolerated these devices well.

Some side effects have been reported, but they are usually mild and manageable. Overall, the safety record for these devices is encouraging, prompting researchers to continue studying them. However, discussing any concerns with a doctor before joining a trial is important. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the networked neuroprosthetic system for spinal cord injury because it offers a groundbreaking way to restore hand, arm, and trunk functions. Unlike traditional treatments, which may rely on physical therapy or external devices, this system involves an implanted device that directly interfaces with the nervous system. This innovative approach allows for more natural and coordinated movements, potentially improving the quality of life for those with spinal cord injuries. Additionally, the system's integration with the body could lead to more effective and personalized rehabilitation outcomes compared to existing methods.

What evidence suggests that this neuroprosthetic system is effective for spinal cord injury?

Research has shown that implanted devices called neuroprosthetics have been used for over 30 years to assist people with spinal cord injuries. These devices improve hand and arm movement by sending electrical signals to the muscles. In this trial, participants will receive the Networked Neuroprosthetic System, which previous studies have shown to help people better grasp and release objects. This system aims to restore movement in the hands, arms, and upper body, offering hope for improving daily activities for those with cervical spinal cord injuries. Early results suggest it enhances control and function of the upper body. ^{1 2 3 4 5}

Are You a Good Fit for This Trial?

This trial is for individuals over 16 years old with cervical spinal cord injuries (C4-C8 level, AIS grade A-D) who are at least six months post-injury. Participants must have some arm and trunk muscle strength, be medically stable for surgery, and willing to participate. Pregnant women, those with certain neurological conditions or severe diseases, active infections, or other implantable devices are excluded.

Inclusion Criteria

I am older than 16 years.

I have a spinal cord injury at the neck level and it's been over 6 months since the injury.

My arm and trunk muscles respond well to stimulation.

Exclusion Criteria

You have other implanted medical devices that might not work well with the new implant.

You have a pacemaker or defibrillator, unless there are specific exceptions.

I have fractures that stop me from using my arm or body properly.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Implantation and Initial Assessment

Participants receive the implanted networked neuroprosthetic system and undergo initial functional training and assessment

4-6 weeks

Functional Training and Assessment

Participants undergo functional training and assessment to optimize the use of the neuroprosthetic system for hand, arm, and trunk function

3 months

Regular in-person visits for training and assessment

Follow-up

Participants are monitored for safety and effectiveness after the initial training and assessment phase

3 months

What Are the Treatments Tested in This Trial?

Interventions

• Networked Neuroprosthetic System for Grasp and Trunk

Trial Overview The study tests a fully implanted neuroprosthetic system designed to restore hand function, reach ability, and trunk control in people with cervical spinal cord injuries. It aims to evaluate the device's effectiveness in improving motor functions that were affected by the injury.

How Is the Trial Designed?

Group I: Intervention - implant neuroprosthesis Experimental Treatment 1 Intervention

Receives implanted networked neuroprosthetic system for hand, arm, and trunk function. Undergoes functional training and assessment.

Networked Neuroprosthetic System for Grasp and Trunk is already approved in United States for the following indications:

Approved in United States as Networked Neuroprosthetic System for:

• Cervical spinal cord injury for hand function, reach, and trunk function

Who Is Running the Clinical Trial?

Kevin Kilgore

Lead Sponsor

Trials

1

Recruited

30+

National Institute of Neurological Disorders and Stroke (NINDS)

Collaborator

Trials

1,403

Recruited

655,000+

Congressionally Directed Medical Research Programs

Collaborator

Trials

59

Recruited

10,600+

Case Western Reserve University

Collaborator

Trials

314

Recruited

236,000+

FDA Orphan Products Division

Collaborator

Trials

1

Recruited

30+

Published Research Related to This Trial

The NESS Handmaster neuroprosthesis was found to be safe and effective for improving hand function in individuals with C5 or C6 tetraplegia, with all 7 participants successfully completing daily living tasks after using the device.

Participants showed significant improvements in grip strength (from 0.57 N to 16.5 N) and finger motion (from 0 cm to 8.4 cm), with no safety issues reported, and 6 out of 7 subjects rated their performance as 'excellent' after the intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Persons with C5 or C6 tetraplegia achieve selected functional gains using a neuroprosthesis. Alon, G., McBride, K.[2019]

In a study involving 12 participants with motor complete spinal cord injury, significant electrical activity was detected in 89% of the muscles below the injury level, indicating that these muscles can potentially serve as command sources for neuroprostheses.

At least two muscles from each participant showed enough activity to be considered viable command signals, suggesting that even in cases of clinically complete spinal cord injury, some voluntary control may still exist and can be harnessed for restoring movement functions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A novel command signal for motor neuroprosthetic control. Moss, CW., Kilgore, KL., Peckham, PH.[2021]

The advanced neuroprosthesis has been successfully implanted in 4 individuals with cervical spinal cord injuries, showing significant improvements in grasp strength, range of motion, and independence in daily activities over a minimum follow-up of 16 months.

No medical complications were reported from the implanted components, indicating the system's safety and stability in providing essential grasping and reaching functions for users with tetraplegia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An advanced neuroprosthesis for restoration of hand and upper arm control using an implantable controller. Peckham, PH., Kilgore, KL., Keith, MW., et al.[2019]

The implanted neuroprosthesis successfully restored arm and hand function in two individuals with high-level tetraplegia, demonstrating functionality for at least 2.5 years post-implantation.

Both participants were able to achieve movements in the hand, wrist, elbow, and shoulder, allowing them to perform some activities of daily living, although they required a mobile arm support due to limitations from spasticity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implanted neuroprosthesis for restoring arm and hand function in people with high level tetraplegia. Memberg, WD., Polasek, KH., Hart, RL., et al.[2021]

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]

The Freehand system is the first implantable neuroprosthesis that helps tetraplegic patients with stable shoulder function regain grasp and hold capabilities, significantly improving their ability to perform daily activities.

Successful use of the neuroprosthesis relies on careful preoperative planning, muscle stimulation, and tailored rehabilitation, which together enhance patients' quality of life and independence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neuroprosthetics of the upper extremity--clinical application in spinal cord injury and future perspectives. Rupp, R., Gerner, HJ.[2005]

In a study involving 19 patients with complete thoracic spinal cord injury, the Neuro-Spinal Scaffold (NSS) implantation was found to be safe, with no serious adverse effects reported over a 24-month follow-up period.

44% of evaluable patients showed neurological improvement, with some achieving higher ASIA Impairment Scale grades at 12 and 24 months, indicating potential long-term benefits of the NSS in promoting recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acute Implantation of a Bioresorbable Polymer Scaffold in Patients With Complete Thoracic Spinal Cord Injury: 24-Month Follow-up From the INSPIRE Study. Kim, KD., Lee, KS., Coric, D., et al.[2023]

Neuroprosthetic systems for upper extremity use in spinal cord injured individuals have been successfully implanted for over 20 years, demonstrating significant long-term durability.

The implanted components, especially the stimulating electrodes and leads, have shown a high level of durability, which is crucial for devices expected to function for potentially over 50 years.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Twenty year experience with implanted neuroprostheses. Kilgore, KL., Peckham, P., Keith, MW.[2020]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6786403/

Risk-benefit value of upper extremity function by an ... Implanted neural stimulation devices (neuroprosthetics) have been used in spinal cord injury (SCI) for over 30 years. One implanted ...

2. apps.dtic.mil apps.dtic.mil/sti/tr/pdf/AD1093290.pdf

Efficacy Study of a Fully Implanted Neuroprosthesis for ... - DTIC We propose to complete a Phase II Clinical Trial to demonstrate the safety and efficacy of a fully-implanted neuroprosthesis to provide upper extremity function ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05863754?term=neuroprosthesis&viewType=Table&rank=4

Grasp-Release Assessment of a Networked ... The overall objective of this trial is to characterize the safety and effectiveness of the Networked Neuroprosthesis Device - Upper Extremity (NP-UE) in ...

4. fescenter.org fescenter.org/research/clinical-trials/spinal-cord-injury-programs/grasp-release-assessment-nnp-device/

Grasp-Release Device Assessment This study is testing the effectiveness of an implanted networked neuroprosthesis device to improve the ability to grasp and release objects.

5. withpower.com withpower.com/trial/phase-spinal-cord-injuries-1-2022-1c144

Neuroprosthesis Device for Spinal Cord Injury This trial is testing an implantable device called NP-UE that helps people with cervical spinal cord injuries move their arms and hands.