Neuroprosthesis Device for Spinal Cord Injury

(GRANND Trial)

Overseen By KIm Walsh, OTR/L

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: MetroHealth Medical Center

Disqualifiers: MS, Diabetes, Cervical spine pathology, 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: 3

13 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new device, the Networked Neuroprosthesis Device, to help people with spinal cord injuries regain arm and hand function. The researchers aim to determine if this device is safe and effective for those with cervical spinal cord injuries. Participants will have the device implanted and then undergo training to improve upper limb movement. It suits individuals who have had a stable spinal cord injury for over six months and retain some muscle function in their arms. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could enhance future treatments for spinal cord injuries.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team to get a clear answer.

What prior data suggests that the Networked Neuroprosthesis Device is safe for individuals with spinal cord injury?

Research shows that implanted devices for spinal cord injuries have been used safely for over 30 years, aiming to improve arm and hand movements. Although the specific device under study, the Networked Neuroprosthesis Device (NP-UE), is still in testing, similar devices have demonstrated a good safety record. Some adverse events have been reported, but they are usually mild and manageable. Based on this information, the treatment is expected to be well-tolerated. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the networked neuroprosthesis device for spinal cord injury because it represents a leap forward in restoring arm and hand function. Unlike traditional treatments, which might include physical therapy or medications to manage symptoms, this device directly interfaces with the nervous system. It uses a sophisticated network of sensors and electrodes implanted in the body, allowing for more precise control and coordination of movements. This innovative approach has the potential to significantly improve the quality of life for individuals with spinal cord injuries by offering them greater independence and functionality.

What evidence suggests that the Networked Neuroprosthesis Device is effective for spinal cord injury?

Research shows that devices called implanted neuroprosthetics have helped people with spinal cord injuries for over 30 years. In this trial, participants will receive the Networked Neuroprosthesis Device, which sends electrical signals to muscles to improve arm and hand movement. Studies have found that similar devices can help people with spinal cord injuries regain movement. In previous trials, researchers successfully implanted the Networked Neuroprosthesis System in several participants, and follow-ups showed promising improvements in their arm and hand movement. This suggests that the device could effectively improve upper body movement for those with injuries to the neck area of the spinal cord. ^{1 2 4 5 6}

Who Is on the Research Team?

Anne Bryden, PhD, OTR/L

Principal Investigator

MetroHealth Medical Center

Are You a Good Fit for This Trial?

This trial is for individuals over 16 years old with a stable cervical spinal cord injury (SCI) at levels C1-C7 and AIS grades A, B, or C. They must have certain upper extremity muscle strength and be medically stable. Excluded are those with other neurological conditions, active infections, pregnancy, co-existing cervical spine issues, or involvement in conflicting studies.

Inclusion Criteria

My spinal cord injury is in my neck and is classified as severe to moderate.

I had nerve surgery on my arm and have been stable for over a year.

My health condition is currently stable.

Exclusion Criteria

I have a history of blood clotting disorders, HIV, heart/lung disease, slow heart rate, uncontrolled nerve system reactions, or COPD.

Progressive SCI

I have a neurological condition like MS or diabetes affecting my nerves.

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

3 months

Multiple visits for implantation and initial assessments

Post-implant Follow-up

Participants are monitored for safety and effectiveness with assessments at 3, 6, and 12 months post-implant

12 months

Assessments at 3, 6, and 12 months post-implant

What Are the Treatments Tested in This Trial?

Interventions

• Networked Neuroprosthesis Device

Trial Overview The Networked Neuroprosthesis Device - Upper Extremity (NP-UE) is being tested for safety and effectiveness in helping people with cervical SCI to regain grasp-release functions of their hands.

How Is the Trial Designed?

Group I: Experimental: Intervention - implant neuroprosthesis Experimental Treatment 1 Intervention

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

Networked Neuroprosthesis Device is already approved in United States for the following indications:

Approved in United States as Networked Neuroprosthesis Device for:

• Upper extremity function in individuals with cervical spinal cord injury (SCI)

Who Is Running the Clinical Trial?

MetroHealth Medical Center

Lead Sponsor

Trials

125

Recruited

22,600+

National Institute of Neurological Disorders and Stroke (NINDS)

Collaborator

Trials

1,403

Recruited

655,000+

Case Western Reserve University

Collaborator

Trials

314

Recruited

236,000+

Published Research Related to This Trial

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]

Neuroprosthetic systems are being developed to assist severely disabled individuals, highlighting the importance of balancing their innovative benefits with potential risks.

The FDA is actively promoting a patient-centered approach in the development of these devices, emphasizing the need for patient input in assessing the benefits and risks throughout the product's life cycle.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neuroprosthetics and the science of patient input. Benz, HL., Civillico, EF.[2019]

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 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 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]

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]

Combining neuromuscular electrical stimulation (NMES) with robotic devices can enhance the accuracy and repeatability of arm and hand movements in individuals with tetraplegia, potentially restoring functional independence after spinal cord injuries.

Current hybrid NMES-robotic systems face challenges in usability outside clinical settings due to their complexity, highlighting the need for improvements in technology, user interfaces, and standardized performance assessments to facilitate real-world application.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A review of methods for achieving upper limb movement following spinal cord injury through hybrid muscle stimulation and robotic assistance. Dunkelberger, N., Schearer, EM., O'Malley, MK.[2020]

Implanted neuroprostheses that electrically stimulate paralyzed muscles can significantly improve functional abilities in individuals with spinal cord injuries and strokes, enabling activities like standing, stepping, and grasping.

These devices are designed for chronic use, offering reliable and low-maintenance solutions that are generally well-accepted by patients, highlighting their potential for long-term rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implanted stimulators for restoration of function in spinal cord injury. Bhadra, N., Kilgore, KL., Peckham, PH.[2019]

Citations

1. 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 ...

2. 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 ...

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

Efficacy Study of a Fully Implanted Neuroprosthesis for ... - DTIC We successfully implanted the Networked Neuroprosthesis (NNP) System in five spinal cord injured subjects. All subject follow-up was performed under the ...

4. 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. The device sends ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7353817/

Powering strategies for implanted multi-function ... Implantable motor neuroprosthetic systems can restore function to individuals with significant disabilities, such as spinal cord injury, stroke, cerebral palsy,

6. 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.